FDA approves treatment for Clostridium difficile infection

The U.S. Food and Drug Administration today approved Dificid (fidaxomicin) tablets for the treatment of Clostridium difficile-associated diarrhea (CDAD).

Clostridium difficile (C. difficile) is a bacterium that can cause diarrhea and lead to colitis, other serious intestinal conditions, and death in severe cases. C. difficile bacteria are found in the stool of an infected person, and others can become infected if they touch items or surfaces contaminated with the bacteria or spores and then touch their mouths.

The safety and efficacy of Dificid were demonstrated in two trials that included 564 patients with CDAD that compared Dificid with vancomycin, a common antibiotic used to treat CDAD. The clinical response was similar in the Dificid group compared with the vancomycin group in both studies. In some patients with CDAD, symptoms can return. In the Dificid trials, a greater number of patients treated with Dificid had a sustained cure three weeks after treatment ended versus those patients treated with vancomycin.

“In recent years, many in the infectious disease community have seen an increase in the number of cases of people with a C. difficile infection,” said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “Dificid is an effective new treatment option for patients who develop Clostridium difficile-associated diarrhea.”

Dificid, a macrolide antibacterial, should be taken two times a day for 10 days with or without food.

To maintain the effectiveness of Dificid, and to reduce the development of drug-resistant bacteria, the drug should be used only to treat infections that are proven or strongly suspected to be caused by C. difficile.

The most common side effects reported with Dificid included nausea, vomiting, headache, abdominal pain, and diarrhea.

People at risk of developing the bacterial infection include the elderly, patients in hospitals or nursing homes, and people taking antibiotics for another infection. The most effective way to prevent CDAD is thorough handwashing with soap and warm water.

Dificid was developed by San Diego-based Optimer Pharmaceuticals Inc.

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New Shoulder Surgery Successfully Treats Serious Injuries

A surgeon at the Emory Sports Medicine Center has helped to pioneer a surgical option for people suffering from severe shoulder injuries.

Spero Karas, MD, Emory orthopaedic surgeon and team doctor for the Atlanta Falcons, has found safe and effective results using a procedure called the “Bridge Technique” for rotator cuff injuries. This procedure uses a skin graft that is surgically attached to both the deficient tendon and bone to ‘bridge’ the defect.

“We have a number of treatments available to fix most rotator cuff injuries, but there are times when the tendon defect is so severe that those options are inadequate,” says Karas, who is also an associate professor of orthopaedics at Emory University School of Medicine.

For individuals with severe injuries that were untreatable in the past, this is a procedure that now offers a potential alternative.

"When the rotator cuff is repaired using this technique, it reestablishes normal function of the rotator cuff," Karas explains. "This results in eliminating pain, improving function and potentially slowing the progression of arthritis."

Not only does this procedure offer help for patients who may never have been able to completely recover from a serious injury, but Karas says it also may give the patient the ability to return to normal activity.

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FDA approves new treatment for Type 2 diabetes

The U.S. Food and Drug Administration today approved Tradjenta (linagliptin) tablets, used with diet and exercise, to improve blood glucose control in adults with Type 2 diabetes.

People with Type 2 diabetes do not produce or respond normally to insulin, a hormone that regulates the amount of glucose in the blood. Over time, high blood glucose levels can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney damage.

"This approval provides another treatment option for the millions of Americans with Type 2 diabetes," said Mary Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “It is effective when used alone or when added to existing treatment regimens.”

Type 2 diabetes is the most common form of the disease, affecting between 90 percent and 95 percent of the 24 million people in the United States with diabetes. Tradjenta increases the level of hormones that stimulate the release of insulin after a meal by blocking the enzyme dipeptidyl peptidase-4 or DPP-4, which leads to better blood glucose control.

Tradjenta was demonstrated to be safe and effective in eight double-blind, placebo-controlled clinical studies involving about 3,800 patients with Type 2 diabetes. The studies showed improvement in blood glucose control compared with placebo.

Tradjenta has been studied as a stand-alone therapy and in combination with other Type 2 diabetes therapies including metformin, glimepiride, and pioglitazone. Tradjenta has not been studied in combination with insulin, and should not be used to treat people with Type 1 diabetes or in those who have increased ketones in their blood or urine (diabetic ketoacidosis).

Tradjenta will be dispensed with an FDA-approved Patient Package Insert that explains the drug’s uses and risks. The most common side effects of Tradjenta are upper respiratory infection, stuffy or runny nose, sore throat, muscle pain, and headache.

Tradjenta is marketed by Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Conn., and Indianapolis-based Eli Lilly Co.

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Protein Inhibitor May Bring a Topical Treatment for HPV

/PRNewswire/ -- Human papillomavirus (HPV) causes cervical cancer, the second most common cause of cancer death for women, and is a common cause of anogenital and some head and neck cancers. Thanks to research being done at Tufts University School of Medicine, patients infected with cancer-causing HPV may someday have an alternative to surgical and harsh chemical treatments. In a study funded by the National Institutes of Health and published online in advance of print in The FASEB Journal, the researchers report on the development of a protein-based inhibitor that could provide a topical treatment for HPV.

"Currently, there is no cure for HPV, and the available treatment options involve destroying the affected tissue. We have developed a protein inhibitor that blocks HPV protein expression in cell culture, a first step toward a topically-applied treatment for this cancer-causing virus," said senior author James Baleja, Ph.D., associate professor of biochemistry at Tufts University School of Medicine (TUSM) and member of the biochemistry program faculty at the Sackler School of Graduate Biomedical Sciences at Tufts.

"Vaccines are helping to lower the incidence of HPV, but vaccines will not help the millions of women and men who currently have an infection, especially those who have high-risk and persistent infections. Social and economic challenges make widespread administration of a vaccine difficult, particularly in developing countries. A topical treatment for HPV could provide an economical option," he continued.

HPV affects approximately 20 million people in the United States, making it the most common sexually transmitted infection. There are more than 100 types of HPV of which more than 40 are sexually transmitted. These include two high-risk types, HPV-16 and HPV-18, which cause the majority of cervical and anogenital cancers, and some portion of head and neck cancers, particularly oral cavity and oropharynx cancers. Cervical cancer is diagnosed in nearly 500,000 women each year, killing 250,000 annually. In the United States, it was estimated that 12,000 women in 2010 would be diagnosed with cervical cancer, while 10,100 women and men in the United States get vulvar, vaginal, penile or anal cancers each year. In addition, some portion of the head and neck cancers in the United States (11,300 men and women each year) is attributable to HPV. Other types of HPV, or low-risk HPV, can cause genital warts or are infections that clear on their own.

In their efforts to inhibit HPV, Baleja and his team zeroed in on the viral protein E2, which controls viral activities including DNA replication and the activation of cancer-causing genes. Using structure-guided design, the team developed a protein called E2R that prevents E2 from functioning normally. When the researchers applied E2R to a cell model of HPV biology, viral gene transcription was halted. Because HPV infects epithelial cells, the outermost layer of the skin and the mucous membranes, protein inhibitors such as E2R could be applied in a topical form.

Baleja and colleagues used biophysical tools including circular dichroism spectroscopy and x-ray crystallography to test the structure and stability of different inhibitors. The most stable inhibitor was then tested in mammalian cells and was found to inhibit the E2 protein of HPV-16, the high-risk strain that is most commonly associated with cancers. The data in this study suggest that the inhibitor may also be effective against another high-risk virus, HPV-18, as well as a low-risk virus, HPV-6a, which causes warts.

Additional authors on the paper are first author Kakoli Bose, Ph.D., formerly a postdoctoral fellow in the Baleja laboratory at TUSM and now with the Advanced Centre for Treatment, Research and Education in Cancer at the Tata Memorial Center in India; Gretchen Meinke, Ph.D., senior research associate in the Bohm Laboratory at TUSM, and Andrew Bohm, associate professor in the Department of Biochemistry at TUSM and member of the biochemistry program faculty at the Sackler School of Graduate Biomedical Sciences.

This research was funded by the National Cancer Institute, part of the National Institutes of Health, and by the Lifespan/Tufts/Brown Center for AIDS Research (CFAR), a joint research effort between Tufts and Brown Universities and their affiliated hospitals and centers. CFAR is funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.

Bose K, Meinke G, Bohm A, and Baleja J. The FASEB Journal. "Design and characterization of an enhanced repressor of human papillomavirus E2 protein." Published online April 11, 2011. DOI 10.1096/fj.10-176461

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Study Suggests an Alternative to Foot Amputation for Some Diabetic Patients

/PRNewswire/ -- A recent study published in the March issue of Foot & Ankle International (FAI), the official scientific journal of the American Orthopaedic Foot & Ankle Society (AOFAS) describes a possible amputation alternative for patients with neuropathic ulceration of the first metatarsophalangeal (MTP) or big toe joint. The findings are noteworthy as diabetes is the leading cause for non-accident/injury leg and foot amputations among US adults, with more than 60,000 lower extremity amputations performed annually. In addition, neuropathy (nerve damage or loss of feeling) of the foot occurs in 60-70% of diabetic patients.

The study's alternative operative treatment to amputation includes debridement and resection arthroplasty with temporary external fixation and VAC dressing. Nicholas Smith, corresponding author of the study says, "While the study includes only a small sample, it does represents the largest group followed in literature. Given that patients are very satisfied with the outcomes and that we achieved an equally positive end point compared to more radical amputation, we are hopeful that this option will be considered for select patients in the future."

The retrospective study examined 16 patients (the largest group followed in the literature) who underwent resection arthroplasty with external fixation for first MTP ulceration. The patients were studied post-operatively for an eight year period. The purpose of the study was to obtain information on long-term outcomes for all patients who underwent the procedure. Ten out of 16 patients were ulcer free at the conclusion of the study and required no further surgery. The remaining six patients required a secondary procedure which required amputation.

Treatment includes complete debridement of the infected tissue, application of external fixator with pins and wires, and 6 to 8 weeks of antibiotics with use of negative pressure wound therapy (NPWT) for the postoperative treatment of open wounds

The findings are noteworthy for diabetic patients with foot ulcerations. The authors of the study feel the procedure warrants consideration in the treatment of deep forefoot ulcerations, yet concede that if the ulceration fails to heal, amputation may be the only viable option.

For more information on diabetic foot as well as resources on foot and ankle care, visit the AOFAS website, www.aofas.org. The site also features a surgeon referral service that makes it easy for patients to find a local orthopaedic surgeon specializing in foot and ankle care.

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FDA approves the first vaccine to prevent meningococcal disease in infants and toddlers

The U.S. Food and Drug Administration today approved the use of Menactra in children as young as 9 months for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135. Menactra already is approved for use in people ages 2 through 55 years.

Meningococcal disease is a life-threatening illness caused by bacteria that infect the bloodstream (sepsis) and the lining that surrounds the brain and spinal cord (meningitis). Neisseria meningitidis is a leading cause of meningitis in young children. Even with appropriate antibiotics and intensive care, between 10 percent and 15 percent of people who develop meningococcal disease die from the infection. Another 10 percent to 20 percent suffer complications such as brain damage or loss of limb or hearing.

Although the rates of meningococcal disease are low in the United States, infants and toddlers are more susceptible to getting this serious illness. Meningococcal disease is particularly dangerous because it progresses rapidly and can cause death within hours. Early symptoms are often difficult to distinguish from influenza and other common illnesses.

“The highest rate of meningococcal disease occurs in children under one year of age. With today’s approval, Menactra can now be used in children as young as 9 months of age to help prevent this potentially life-threatening disease,” said Karen Midthun, M.D., director of FDA's Center for Biologics Evaluation and Research.

The safety of Menactra in children as young as 9 months was evaluated in four clinical studies in which over 3,700 participants received the vaccine. The most common adverse events reported in children who received Menactra at 9 months and 12 months of age were injection-site tenderness and irritability. Occurrence of fever was comparable to other vaccines routinely recommended for young children.

Menactra is given as a two-dose series beginning at 9-months, three months apart; and the study results showed the vaccine produces antibodies in the blood that are protective against the disease.

Menactra was originally approved on Jan. 14, 2005, for use in individuals ages 11 years through 55 years and was approved in October 2007 for children as young as 2 years. Menactra is manufactured by Sanofi Pasteur Inc. of Swiftwater, Pa.

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UGA compound offers new hope for treatment of painful adult shingles

Researchers at the University of Georgia and Yale University have discovered a compound with the potential to be more effective than existing agents in treating the very painful blisters known as shingles—a condition that affects up to 30 percent of Americans, mostly elderly, and for which no specific treatment exists.

Most adults remember the fever, itchy blisters and possibly tiny scars they experienced as children when they had chickenpox, which is caused by the varicella-zoster virus, or VZV.Unfortunately, that memory can come back—with a vengeance—when they are older. The VZV virus from childhood chickenpox hides in the nerves, emerging most frequently in adults over the age of 60 as a blistering rash on one side of the body. The rate of complications, including nerve pain that can persist for months or years after the shingles attack is gone, also increases with age.

The novel and effective anti-shingles agent called L-BHDA may change that. Rights to the shingles treatment have been licensed to Bukwang Pharmaceutical Company for preclinical investigations by the University of Georgia Research Foundation, Inc. and Yale University.

“We need new options for medications with increased potency and specificity that can treat VZV, including strains that may be resistant to existing drugs,” said medicinal chemist Chung (David) Chu, Distinguished Research Professor of Pharmaceutical and Biomedical Sciences at UGA, one of the inventors of L-BHDA.

A collaboration between Chu and co-inventor Yung-Chi (Tommy) Cheng, the Henry Bronson Professor of Pharmacology at Yale, has resulted in an extensive portfolio of antiviral compounds that target such diseases as HIV, shingles, hepatitis and cancers.

Chu, who is head of the Drug Discovery Group in the UGA College of Pharmacy, said that although there are generic antiviral drugs to reduce the duration and pain of shingles, and a variety of pain medications and topical creams to relieve long-term pain, “They are only moderately effective.We need more effective anti-VZV agents.

“L-BHDA has the potential to be more effective than existing agents,” said Chu. He noted that the new compound has been tested in the laboratory and demonstrated in mice models by a group of researchers headed by Jennifer Moffat, associate professor of microbiology and immunology, State University of New York Upstate Medical University.

A vaccine to prevent shingles, available to older adults since 2006, can cut the likelihood of a shingles attack in half. However, according to a recent study in the American Journal of Preventive Medicine, only a small percentage of older people receive the shot, principally because of cost, lack of insurance reimbursement and shortage of supply.

It is likely that immunization against chickenpox during childhood also protects against shingles, because the vaccine uses a weakened strain of the virus. However, the vaccine was only introduced in 1995, and there are not enough data to provide a definitive answer.

“Dr. Chu and Dr. Cheng have been working diligently to fill a much needed gap in the treatment options for such a prevalent disease,” said Rachael Widener, UGARF technology licensing manager. “Before the chicken pox vaccine became widely used in the mid-1990s, older, unvaccinated individuals would have their immunity boosted naturally.

“Now, with less exposure to chicken pox, shingles is becoming more prevalent,” said Widener. “This, combined with the aging baby boomer population, underscores the need for more directed treatment. We are hopeful that L-BHDA will allow patients to get well sooner and feel less pain, and will lessen their chances of complications.”

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FDA approves Rituxan to treat two rare disorders

The U.S. Food and Drug Administration today approved Rituxan (rituximab), in combination with glucocorticoids (steroids), to treat patients with Wegener’s granulomatosis (WG) and microscopic polyangiitis (MPA), two rare disorders that cause blood vessel inflammation (vasculitis).

Vasculitis in patients with WG and MPA can lead to tissue damage. WG mostly affects the respiratory tract (sinuses, nose, trachea, and lungs) and kidneys, while MPA commonly affects the kidneys, lungs, nerves, skin, and joints. Both of these diseases affect people of all ages and ethnicities, and both genders. The causes of these disorders are unknown, and both are considered orphan diseases because they each affect less than 200,000 people in the United States.

“This new indication for Rituxan provides the first approved therapy for these two orphan diseases,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.

Rituxan is an antibody that is manufactured through biotechnology methods. The drug works by greatly reducing the number of specific immune cells in the blood, known as B cells.

The safety and effectiveness of Rituxan was demonstrated in a single controlled trial, in which 197 patients with WG or MPA were assigned at random to receive either Rituxan plus glucocorticoids once a week for four weeks or oral cyclophosphamide plus glucocorticoids daily to induce remission. After six months, 64 percent of patients treated with Rituxan had complete remission compared to 53 percent of patients treated with cyclosphosphamide.

Retreatment with Rituxan was not formally evaluated; therefore, the safety and efficacy of retreatment with subsequent courses of Rituxan has not been established. More data are needed to determine the safety of more than one course of Rituxan and long term safety of use of Rituxan in patients with WG and MPA. These questions will be further evaluated in a required post-marketing study.

Rituxan carries a Boxed Warning for infusion reactions, which can occur during infusion or within 24 hours afterwards. Other Boxed Warnings for Rituxan include rashes and sores in the skin and mouth (severe mucocutaneous reactions); and progressive multifocal leukoencephalopathy, a brain infection that generally is fatal. Rituxan is not recommended for use in patients with severe, active infections.

The most common side effects in study participants with WG and MPA included infection, nausea, diarrhea, headache, muscle spasms, and anemia.

Rituxan, which has been marketed since 1997, is also indicated for the treatment of patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis.

Rituxan is manufactured by San Francisco-based Genentech, a member of the Roche Group.

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FDA approves Actemra to treat rare form of juvenile arthritis

The U.S. Food and Drug Administration today approved Actemra (tocilizumab), given alone or in combination with methotrexate, for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in children ages 2 years and older.

SJIA, or Still’s disease, is a rare, potentially life-threatening disorder in children that causes severe inflammation throughout the body. SJIA is distinguished from other forms of juvenile idiopathic arthritis (JIA) by the prominence of systemic and inflammatory features, including spiking fevers; rash; swelling and inflammation of lymph nodes, liver, and spleen; and high white blood cell and platelet counts. The prevalence of JIA is an estimated 1 to 2 per 1,000 children, and SJIA affects about 10 percent of all JIA patients.

Actemra is an interleukin-6 receptor blocker approved by the FDA on Jan. 8, 2010, for treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to other approved therapies.

“This new indication of Actemra provides the first approved therapy for children with this rare disease,” said Badrul Chowdhury, M.D., Ph.D., director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.

An international, multicenter controlled trial demonstrated the safety and effectiveness of Actemra, in which 112 patients received either Actemra infusions or placebo infusions every two weeks. Study participants included patients with SJIA aged 2 to 17 years old who had inadequate response to or who were unable to take nonsteroidal anti-inflammatory drugs and corticosteroids.

Eighty-five percent of those receiving Actemra responded to treatment, compared with 24 percent of patients receiving placebo. Response was defined as at least 30 percent improvement in the American College of Rheumatology’s JIA efficacy variables, along with absence of fever in the preceding seven days. In the long-term, follow-up period of the trial there were three cases of macrophage activation syndrome (MAS) among SJIA patients receiving Actemra. MAS is a potentially fatal complication of childhood systemic inflammatory disorders, thought to be caused by excessive activation and proliferation of certain immune cells.

Actemra carries a Boxed Warning for serious infections. Patients treated with Actemra who develop a serious infection should stop Actemra treatment until the infection is controlled. A Boxed Warning is a brief, concise summary of the information that is critical for a prescriber to be aware of, including any restriction on distribution or use, which is included in a black box at the beginning of the drug label.

Changes in certain laboratory test results such as liver tests, blood counts, and cholesterol are not uncommon with Actemra and should be monitored with regular blood tests. The most common side effects in trial participants with SJIA included upper respiratory tract infection, headache, sore throat, and diarrhea.

Actemra is marketed by San Francisco-based Genentech Inc., a subsidiary of the Roche Group.

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Doctors Recommend Different Treatments for Patients Than for Themselves

A patient who can't decide between two available treatments asks his doctor: "What should I do?" Another patient, torn between the same two treatments, asks: "Doctor, what would you do if you were me?"

Will those two patients get the same answer? That question, posed by researchers from Duke University and the University of Michigan in a national survey of physicians, found doctors often recommend different treatments for patients than they would choose for themselves.

The study, from professor Peter Ubel and post-doctoral associate Andrea Angott of Duke University's Fuqua School of Business and professor Brian Zikmund-Fisher of the University of Michigan, appears in the April 11 edition of the Archives of Internal Medicine. Funding for the study was provided by the American Cancer Society, the National Science Foundation and the National Institutes of Health.

In the study, the researchers conducted a randomized experiment asking some physicians to make a recommendation to a patient seeking advice, while other physicians were asked what they themselves would choose as a patient facing the same health care decision.

Doctors frequently advised patients to pursue treatments with higher rates of side effects and lower mortality rates, while choosing treatments with lower rates of side effects and higher mortality rates for themselves.

"Our research found that people felt living with a colostomy or being paralyzed was better than dying. From that perspective, the ‘right' decision is to take the risk of side effects and reduce the chances of dying," Ubel said.

However, emotions brought on by potential significant side effects often push people away from the "right" decision. Doctors -- free from the side effects of treatment -- can make more objective treatment recommendations to their patients.

"When making recommendations to patients, physicians can push aside any emotions that would lead them astray," Ubel said. "But those emotions may loom large when a doctor is deciding for him or herself. In other words, the act of giving advice to others may reset the balance between emotion and reason."

Ubel noted, "Many physicians are biased by their own backgrounds, valuing things that patients don't necessarily value, or they can even be influenced by financial and professional conflicts of interest that can skew judgment."

As a result, you might not always get the objective advice you seek, Ubel said. "Instead, the advice you get could depend on whether your doctor is thinking about what you should do, or instead thinking about what he or she would do in your situation."

A detailed report on the research is available at http://archinte.ama-assn.org/.

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FDA approves new treatment for large brain aneurysms

The U.S. Food and Drug Administration has approved the cPAX Aneurysm Treatment System for surgery on brain aneurysms that are difficult to manage because of their size and shape.

An aneurysm is a bulge in the wall of a blood vessel, which can rupture as it increases in size, causing hemorrhage or death. Brain aneurysms often produce no symptoms until they grow and press on nerves in the brain, or until they begin to leak blood or rupture.

Aneurysms can be repaired in two ways: surgeons can close the base of the aneurysm with a surgical clip, or use a technique commonly known as coiling, in which surgeons use a catheter to thread metallic coils through a blood vessel in the groin and into the blood vessel in the brain that contains the aneurysm. Surgeons then fill the aneurysm with the detachable coils, which block it from circulation and cause blood to clot, effectively destroying the aneurysm.

Aneurysms larger than 10millimeters are difficult to treat with clipping or coiling. The cPAX Aneurysm Treatment System is indicated for use in those brain aneurysms.

“Like coiling, the cPAX Aneurysm Treatment System is a form of endovascular repair,” said Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “But instead of tiny metallic coils, it uses a special polymer material to fill the space within the aneurysm.”

The cPAX polymeric filler material can be secured in the aneurysm in one of two ways, either by insertion through openings in a permanent stent, which is a tiny metal scaffold placed along the vessel wall, or by using a temporary balloon catheter to block off the opening to the aneurysm and keep the filler material from coming out of the aneurysm as it is being delivered.

By filling the bulging space within the aneurysm with implant material, the blood flow through the aneurysm is stopped and any remaining space around the implant material clots. When filled with implant material and blood clot, and the risk of rupture of the aneurysm decreases.

The cPAX Aneurysm Treatment System was approved on April 1, 2011, under a Humanitarian Device Exemption (HDE). The HDE makes medical devices available to patients with rare medical conditions that affect fewer than 4,000 people a year. The approval for this HDE was based on safety data from two studies of 43 subjects.

The cPAX device system is indicated for use in adults ages 22 and older and should not be used in patients with an active infection or in those in whom anticoagulation and antiplatelet therapy is contraindicated.

The cPAX Aneurysm Treatment System is manufactured by Neurovasx Inc., Maple Grove, Min.

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FDA approves Horizant to treat restless legs syndrome

On April 6, the U.S. Food and Drug Administration approved Horizant Extended Release Tablets (gabapentin enacarbil), a once-daily treatment for moderate-to-severe restless legs syndrome (RLS).

RLS is a disorder that causes a strong urge to move the legs. This urge often occurs with unpleasant feelings in the legs. People who have RLS describe feeling pulling, itching, tingling, burning, or aching in their legs, and moving the legs temporarily relieves these feelings. The urge to move often happens when a person is inactive, and the symptoms typically are worse in the evening and early morning.

“People with restless legs syndrome can experience considerable distress from their symptoms,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Horizant provides significant help in treating these symptoms.”

The effectiveness of Horizant was studied in two 12-week clinical trials in adults. The trials showed that people taking the medication had an improvement in their RLS symptoms, compared with people taking an inactive pill (placebo).

Horizant will be dispensed with an FDA-approved Medication Guide that explains the drug’s uses and risks. Horizant may cause drowsiness and dizziness and can impair a person’s ability to drive or operate complex machinery.

Horizant contains gabapentin enacarbil that becomes gabapentin, a drug used to treat seizures in people with epilepsy, when absorbed into the body. All drugs used to treat epilepsy carry warnings that they may cause suicidal thoughts and actions in a small number of people. Horizant will have the same warning.

Horizant was developed by GlaxoSmithKline of Research Triangle Park, N.C., and Xenoport of Santa Clara, Calif.

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FDA approves new treatment for rare form of thyroid cancer

The U.S. Food and Drug Administration today (April 6) approved vandetanib to treat adult patients with late-stage (metastatic) medullary thyroid cancer who are ineligible for surgery and who have disease that is growing or causing symptoms.

Thyroid cancer is a cancerous growth of the thyroid gland, which is located in the neck. Medullary thyroid cancer involves specific types of cells that are found in the thyroid gland and can occur spontaneously, or be part of a genetic syndrome.

About 44,600 new thyroid cancer cases were diagnosed in the United States during 2010, and about 1,690 people died from the disease, according to the National Cancer Institute. Medullary thyroid cancer is estimated to represent 3 to 5 percent of all thyroid cancer; its estimated incidence in the United States for 2010 is about 1,300 to 2,200 patients, making it one of the rarer forms of thyroid cancer.

Common symptoms of medullary thyroid cancer may include coughing, difficulty swallowing, enlargement of the thyroid gland, swelling of the neck, a lump on the thyroid, and changes in a person’s voice or hoarseness.

Vandetanib targets medullary thyroid cancer’s ability to grow and expand. There are currently no FDA-approved treatments for this type of cancer. Vandetanib is administered orally on a daily basis.

Vandetanib’s safety and effectiveness were established in a single, randomized international study of 331 patients with late-stage medullary thyroid cancer. Patients in the study were selected to receive vandetanib or placebo (sugar pill).

The study was designed to measure the length of time a patient lived without the individual’s cancer progressing (progression-free survival). Patients who received vandetanib had a longer period of time without disease progression when compared to patients receiving placebo. Median progression-free survival was 16.4 months in the placebo arm and at least 22.6 months in the vandetanib arm. It is too early to determine the median progression-free survival in patients treated with vandetanib or to tell whether they will live longer (overall survival) compared to patients treated with placebo.

“Vandetanib’s approval underscores FDA’s commitment to approving treatments for patients with rare and difficult to treat diseases,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research.

Common side effects occurring from vandetanib use include diarrhea, rash, nausea, high blood pressure, headache, fatigue, decreased appetite, and stomach (abdominal) pain. Serious side effects reported during the study resulted in five deaths in patients treated with vandetanib. Causes of death included breathing complications, heart failure, and a bacterial infection in the blood (sepsis).

Vandetanib was shown to affect the electrical activity of the heart, which in some cases can cause irregular heart beats that could lead to death. Vandetanib is being approved with a Risk Evaluation and Mitigation Strategy (REMS) to inform health care professionals about these serious heart-related risks. Only health care professionals and pharmacies certified through the vandetanib REMS program, a restricted distribution program, will be able to prescribe and dispense the drug. Patients will also receive an FDA-approved Medication Guide informing them of the potential risks.

Vandetanib is marketed by AstraZeneca Pharmaceuticals LP of Wilmington, Del. There is no trade name established for this drug at this time.

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FDA approves Benlysta to treat lupus

The U.S. Food and Drug Administration today approved Benlysta (belimumab) to treat patients with active, autoantibody-positive lupus (systemic lupus erythematosus) who are receiving standard therapy, including corticosteroids, antimalarials, immunosuppressives, and nonsteroidal anti-inflammatory drugs.

Benlysta is delivered directly into a vein (intravenous infusion) and is the first inhibitor designed to target B-lymphocyte stimulator (BLyS) protein, which may reduce the number of abnormal B cells thought to be a problem in lupus.

Prior to Benlysta, FDA last approved drugs to treat lupus, Plaquenil (hydroxychloroquine) and corticosteroids, in 1955. Aspirin was approved to treat lupus in 1948.

Lupus is a serious, potentially fatal, autoimmune disease that attacks healthy tissues. It disproportionately affects women, and usually develops between ages 15 and 44. The disease affects many parts of the body including the joints, the skin, kidneys, lungs, heart, and the brain. When common lupus symptoms appear (flare) they can present as swelling in the joints or joint pain, light sensitivity, fever, chest pain, hair loss, and fatigue.

Estimates vary on the number of lupus sufferers in the United States ranging from approximately 300,000 to 1.5 million people. People of all races can have the disease; however, African American women have a 3 times higher incidence (number of new cases) than Caucasian women.

“Benlysta, when used with existing therapies, may be an important new treatment approach for health care professionals and patients looking to help manage symptoms associated with this disease,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.

Two clinical studies involving 1,684 patients with lupus demonstrated the safety and effectiveness of Benlysta. The studies diagnosed patients with active lupus and randomized them to receive Benlysta plus standard therapy, or an inactive infused solution (placebo) plus standard therapy. The studies excluded patients who had received prior B-cell targeted therapy or intravenous cyclophosphamide, and those who had active lupus involving the kidneys or central nervous system.

Patients treated with Benlysta and standard therapies experienced less disease activity than those who received a placebo and standard of care medicines. Results suggested, but did not definitively establish, that some patients had a reduced likelihood of severe flares, and some reduced their steroid doses.

African American patients and patients of African heritage participating in the two studies did not appear to respond to treatment with Benlysta. The studies lacked sufficient numbers to establish a definite conclusion. To address this concern, the sponsor has agreed to conduct an additional study of people with those backgrounds to further evaluate the safety and effectiveness of Benlysta for this subgroup of lupus patients.

Those receiving Benlysta during clinical studies reported more deaths and serious infections compared with placebo. The drug should not be administered with live vaccines. The manufacturer is required to provide a Medication Guide to inform patients of the risks associated with Benlysta.

The most common side effects in the studies included nausea, diarrhea, and fever (pyrexia). Patients also commonly experienced infusion reactions, so pre-treatment with an antihistamine should be considered.

Human Genome Sciences Inc., based in Rockville, Md., developed Benlysta and will co-market the drug in the United States with GlaxoSmithKline of Philadelphia.

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Cost to Treat Heart Disease in United States Will Triple by 2030

/PRNewswire/ -- The cost to treat heart disease in the United States will triple by 2030, according to a policy statement published in Circulation: Journal of the American Heart Association.

"Despite the successes in reducing and treating heart disease over the last half century, even if we just maintain our current rates, we will have an enormous financial burden on top of the disease itself," said Paul Heidenreich, M.D., chair of the American Heart Association expert panel issuing the statement.

The panel estimated future medical costs based on the current rates of disease and used Census data to adjust for anticipated population shifts in age and race. The rigorous methods they devised didn't double count costs for patients with multiple heart conditions.

"These estimates don't assume that we will continue to make new discoveries to reduce heart disease," Heidenreich said. "If our ability to prevent and treat heart disease stays where we are right now, costs will triple in 20 years just through demographic changes in the population."

The panel said effective prevention strategies are needed to limit the growing burden of cardiovascular disease -- the leading cause of death in the United States that accounts for 17 percent of overall national health expenditures.

"Unhealthy behaviors and unhealthy environments have contributed to a tidal wave of risk factors among many Americans," said Nancy Brown, American Heart Association CEO. "Early intervention and evidence-based public policies are absolute musts to significantly reduce alarming rates of obesity, hypertension, tobacco use and cholesterol levels."

Currently, 1 in 3 Americans (36.9 percent) have some form of heart disease, including high blood pressure, coronary heart disease, heart failure, stroke and other conditions. By 2030, approximately 116 million people in the United States (40.5 percent) will have some form of cardiovascular disease, the panel said. The largest increases are anticipated in stroke (up 24.9 percent) and heart failure (up 25 percent).

Between 2010-30, the cost of medical care for heart disease (in 2008 dollar values) will rise from $273 billion to $818 billion, the authors predicted. "We were all surprised at the remarkable increase in costs that are expected in the next two decades," Heidenreich said. "We need to continue to invest resources in the prevention of disease, the treatment of risk factors and early treatment of existing disease to reduce that burden."

Heart disease will also cost the nation billions more in lost productivity, increasing from an estimated $172 billion in 2010 to $276 billion in 2030. Productivity losses include days missed from home or work tasks because of illness and potential lost earnings due to premature death.

Co-authors writing on behalf of the various councils are: Justin G. Trogdon, Ph.D.; Olga A. Khavjou, M.A.; Javed Butler, M.D.; Kathleen Dracup, R.N., D.N.Sc.; Michael D. Ezekowitz, M.B.Ch.B., D.Phil.; Eric Andrew Finkelstein, Ph.D.; Yuling Hong, M.D., Ph.D.; S. Claiborne Johnston, M.D., Ph.D.; Amit Khera, M.D.; Donald M. Lloyd-Jones, M.D.; Sue A. Nelson, M.P.A.; Graham Nichol, M.D.; Diane Orenstein, Ph.D.; Peter W.F. Wilson M.D. and Y. Joseph Woo, M.D.

Author disclosures are on the manuscript.


The American Heart Association/American Stroke Association receives funding mostly from individuals. Foundations and corporations donate as well, and fund specific programs and events. Strict policies are enforced to prevent these relationships from influencing the association’s science content. Financial information for the American Heart Association, including a list of contributions from pharmaceutical companies and device manufacturers, is available at www.heart.org/corporatefunding .

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FDA Approves Viibryd to Treat Major Depressive Disorder

/PRNewswire/ -- The U.S. Food and Drug Administration today approved Viibryd tablets (vilazodone hydrochloride) to treat major depressive disorder in adults.

Major depressive disorder, also called major depression, is characterized by symptoms that interfere with a person's ability to work, sleep, study, eat, and enjoy once-pleasurable activities. Episodes of major depression often recur throughout a person's lifetime, although some may experience only a single occurrence.

Signs and symptoms of major depression include: depressed mood, loss of interest in usual activities, significant change in weight or appetite, insomnia or excessive sleeping (hypersomnia), restlessness/pacing (psychomotor agitation), increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicide attempts or thoughts of suicide. All people with major depression do not experience the same symptoms.

"Major depressive disorder is disabling and prevents a person from functioning normally," said Thomas Laughren, M.D., director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research. "Medications affect everyone differently, so it is important to have a variety of treatment options available to patients who suffer from depression."

The most frequent adverse reactions reported by patients taking Viibryd in clinical trials included diarrhea, nausea, vomiting, and insomnia.

The drug will be available in 10, 20 and 40 milligram tablets.

Viibryd and all other antidepressant drugs have a boxed warning and a patient medication guide describing the increased risk of suicidal thinking and behavior in children, adolescents, and young adults ages 18 to 24 during initial treatment.

The warning also says data did not show this increased risk in adults older than 24 and that patients ages 65 and older who take antidepressants have a decreased risk of suicidal thinking and behavior. The warning says depression and other serious psychiatric disorders themselves are the most important causes of suicide and that close monitoring of patients starting these medications is necessary.

Viibryd is manufactured by PGxHealth, New Haven, Conn.

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FDA Approves Head Lice Treatment for Children and Adults

The U.S. Food and Drug Administration today approved Natroba (spinosad) Topical Suspension 0.9% for the treatment of head lice infestation in patients ages 4 years and older.

Head lice are parasitic insects found on people’s head, eyebrows, and eyelashes. They feed on human blood several times a day but are not known to cause disease. Head lice are spread mainly by direct head-to-head contact with a person who already has head lice. Lice move by crawling and can easily travel from child to child because children play closely together and often in large groups.

“Natroba provides another option for the topical treatment of head lice infestations, which are especially prevalent in the pediatric population,” said Julie Beitz, M.D., director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research. “Head lice is a common problem among school children in the United States.”

Natroba is a topical drug product and should be applied only to the child’s scalp or hair. The product should be used exactly as prescribed by a health care professional.

The safety and effectiveness of Natroba Topical Suspension 0.9 %, has been established in two multicenter, randomized, active-controlled studies. A total of 552 subjects received a 10-minute treatment with Natroba. If live lice were seen a week later, a second treatment was applied. The proportion of subjects who were lice-free fourteen days after the final treatment of Natroba was approximately 86 percent compared to 44 percent of the control group.

Common adverse events reported include redness or irritation of the eyes and skin.

Safety in pediatric patients below the age of 4 years has not been established. Although Natroba is not approved for use in children younger than 4 years, it is especially important not to use in infants because the product contains benzyl alcohol. Benzyl alcohol has been associated with serious adverse reactions, including death, when applied topically to the skin of children younger than 6 months.

Natroba is manufactured for ParaPRO LLC of Carmel, Ind.

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FDA approves opioid analgesic to help cancer patients manage pain

The U.S. Food and Drug Administration today approved Abstral (fentanyl) transmucosal tablets to manage breakthrough pain for adults with cancer. Fentanyl immediate-release transmucosal medications are administered on the soft surfaces of the mouth (inside of the cheek, gums, tongue), or the nasal passages or throat where they dissolve and are absorbed.

“This is an important step for patients with cancer pain to have options for the treatment of their breakthrough pain,” said John Jenkins, M.D., director of FDA’s Office of New Drugs in the Center for Drug Evaluation and Research.

Abstral is indicated for the management of breakthrough pain in patients with cancer, ages 18 years and older, who already use opioid pain medication around the clock and who need and are able to safely use high doses of an additional opioid medicine. Breakthrough pain is pain that comes on suddenly for short periods of time and is not alleviated by a patient’s normal pain management plan. These patients are considered opioid tolerant because of their current opioid medication use. Only health care professionals skilled in the use of Schedule II opioids to treat pain should prescribe this drug product.

Abstral is available only through a Risk Evaluation and Mitigation Strategy (REMS) program, which is intended to minimize the risk of misuse, abuse, addiction and overdose. Under this program, pharmacies, distributors, and health care professionals who prescribe to outpatients are required to enroll in the program to prescribe, dispense and distribute this product. FDA has standardized key components of the REMS program to facilitate the adoption of a single shared system. These components include the REMS document, the Patient-Prescriber Agreement, and the enrollment form. These components can be used by all sponsors of immediate release transmucosal fentanyl products to develop individual REMS programs such as the program approved for Abstral. FDA has also directed the sponsors of this class of products to work together on a single shared system to implement the REMS.

“This approval is also a significant step toward reducing the burden on the health care system of implementing REMS programs,” added Dr. Jenkins. “When fully implemented, FDA expects that prescribers, pharmacies, and distributors of all immediate release transmucosal fentanyl products will be able to use standardized materials and a single shared system to implement the REMS.”

The safety of Abstral was evaluated in 311 opioid-tolerant cancer patients with breakthrough pain. Two hundred and seventy of these patients were treated in multiple-dose studies. The duration of therapy for patients in multiple-dose studies ranged from 1-405 days with an average duration of 131 days and with 44 patients treated for at least 12 months.

Common adverse reactions include nausea, constipation, drowsiness and headache. Serious adverse events, including deaths, have been reported in patients with other immediate-release transmucosal fentanyl products. The deaths occurred as a result of improper patient selection and/or improper dosing.

Consumers and health care professionals are encouraged to report adverse side effects or medication errors from the use of Abstral to the FDA's MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-332-1088.

Abstral is manufactured by ProStraken Inc., based in Bedminister, N.J.

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FDA: Gardasil approved to prevent anal cancer

The U.S. Food and Drug Administration today (December 22) approved the vaccine Gardasil for the prevention of anal cancer and associated precancerous lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18 in people ages 9 through 26 years.

Gardasil is already approved for the same age population for the prevention of cervical, vulvar, and vaginal cancer and the associated precancerous lesions caused by HPV types 6, 11, 16, and 18 in females. It is also approved for the prevention of genital warts caused by types 6 and 11 in both males and females.

“Treatment for anal cancer is challenging; the use of Gardasil as a method of prevention is important as it may result in fewer diagnoses and the subsequent surgery, radiation or chemotherapy that individuals need to endure,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research.

Although anal cancer is uncommon in the general population, the incidence is increasing. HPV is associated with approximately 90 percent of anal cancer. The American Cancer Society estimates that about 5,300 people are diagnosed with anal cancer each year in the United States, with more women diagnosed than men.

Gardasil’s ability to prevent anal cancer and the associated precancerous lesions [anal intraepithelial neoplasia (AIN) grades 1, 2, and 3] caused by anal HPV-16/18 infection was studied in a randomized, controlled trial of men who self-identified as having sex with men (MSM). This population was studied because it has the highest incidence of anal cancer. At the end of the study period, Gardasil was shown to be 78 percent effective in the prevention of HPV 16- and 18-related AIN. Because anal cancer is the same disease in both males and females, the effectiveness data was used to support the indication in females as well.

Gardasil will not prevent the development of anal precancerous lesions associated with HPV infections already present at the time of vaccination. For all of the indications for use approved by the FDA, Gardasil's full potential for benefit is obtained by those who are vaccinated prior to becoming infected with the HPV strains contained in the vaccine.

Individuals recommended for anal cancer screening by their health care provider should not discontinue screening after receiving Gardasil.

As of May 31, 2010, more than 65 million doses of Gardasil had been distributed worldwide, since its approval in 2006 according to the manufacturer, Merck and Co. Inc, of Whitehouse Station, N.J. The most commonly reported adverse events include fainting, pain at the injection site, headache, nausea, and fever. Fainting is common after injections and vaccinations, especially in adolescents. Falls after fainting may sometimes cause serious injuries, such as head injuries. This can be prevented by keeping the vaccinated person seated for up to 15 minutes after vaccination. This observation period is also recommended to watch for severe allergic reactions, which can occur after any immunization.

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Oncologists Value Survival Over Quality of Life, Study Finds

For oncologists, drugs that help cancer patients live longer are worth more than drugs that help patients live well, according to research from Duke University's Fuqua School of Business and several health-related centers.

On average, oncologists were willing to prescribe treatments that cost about $245,000 to prolong life for one year, but the cost threshold dropped to about $119,000 per year for treatments that improve quality of life without prolonging patients' lives.

"Oncologists are understandably focused on survival, but they need to pay equal attention to the quality of life people experience during and after treatment," said senior author Peter Ubel, M.D., the John O. Blackburn professor of business administration at Fuqua.

The researchers found a wide range in what cancer doctors considered reasonable treatment costs. The threshold varied from $10,000 to $5 million per quality adjusted life year (QALY), a standard for assessing the cost-effectiveness of medical interventions. The spending thresholds assessed in the study were also measured in QALYs.

The research can be found on Medical Decision Making's website: http://bit.ly/fBIYBP.

The results highlight a critical problem in the struggle to control health care costs, Ubel said. Increasingly, doctors are being asked to consider whether very expensive cancer drugs -- some of which offer only small gains in survival -- are worth prescribing. But according to Ubel, the data on cost-effectiveness comes without guidelines for determining appropriate financial value in cancer care.

"Currently, individual oncologists are left to decide whether the benefits of expensive new drugs justify their costs," said Ubel. "Cancer care spending is unlikely to drop when there is such a broad range in what oncologists consider reasonable."

"The fact that these highly trained, wonderful doctors are confused about the issue suggests we as a society should discuss the cost of cancer care more explicitly. With health care spending emptying patients' pocketbooks, and bankrupting state and federal governments, we need to decide how much we should spend for small improvements in the quantity or quality of patients' lives."

The study results are based on a survey sent to members of the American Society of Clinical Oncology. The 768 physicians who responded considered two hypothetical scenarios involving a patient with metastatic cancer and a year to live.

The first scenario asked the doctor how much benefit, in months of survival gained, a new drug would need to provide for them to prescribe it. The new drug cost $75,000 more than standard treatment. The second scenario asked the doctor to indicate the highest cost at which they would prescribe a medication to improve the quality of life without prolonging survival.

The respondents consistently chose to spend more on life-prolonging treatments than on quality-enhancing treatments.

Additional authors of the study include Michael A. Kozminski and Aleksandra Jankovic of the Center for Behavioral and Decision Sciences in Medicine, University of Michigan Medical School in Ann Arbor, Mich.; Peter J. Neuman of the Institute for Clinical Research and Health Policy Studies, Tufts Medical Center in Boston; and Eric S. Nadler of the Charles Sammons Cancer Center, Baylor University Medical Center in Dallas.

The study was funded by grants from the California Healthcare Foundation and the Tufts Medical Center.

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