FDA approves new treatment for rare type of pancreatic cancer

On Thursday, the U.S. Food and Drug Administration approved Afinitor (everolimus) to treat patients with progressive neuroendocrine tumors located in the pancreas (PNET) that cannot be removed by surgery or that have spread to other parts of the body (metastatic).

Neuroendocrine tumors found in the pancreas are slow-growing and rare. It is estimated that there are fewer than 1,000 new cases in the United States each year.

“Patients with this cancer have few effective treatment options,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. “Afinitor has demonstrated the ability to slow the growth and spread of neuroendocrine tumors of the pancreas.”

The safety and effectiveness of Afinitor was established a clinical trial in 410 patients with metastatic (late-stage) or locally advanced (disease that could not be removed with surgery) disease. Patients in the study were selected to receive Afinitor or placebo (sugar pill). The trial was designed to measure the length of time a patient lived before their disease spread or worsened (progression-free survival).

In patients treated with Afinitor, the median length of time they lived without the cancer spreading or worsening was 11 months compared with 4.6 months in patients who received placebo. Patients who received placebo were able to receive Afinitor if their disease worsened.

In patients treated with Afinitor for neuroendocrine pancreatic tumors, the most commonly reported side effects included inflammation of the mouth (stomatitis), rash, diarrhea, fatigue, swelling (edema), stomach (abdominal) pain, nausea, fever, and headache.

Afinitor is also approved to treat patients with kidney cancer (advanced renal cell carcinoma) after they fail treatment with Sutent (sunitinib) or Nexavar (sorafenib); and patients with subependymal giant cell astrocytoma (a type of brain cancer) associated with tuberous sclerosis (a disease that causes tumors in various parts of the body), who cannot be treated by surgery.

Afinitor has another trade name, Zortress, and is approved to treat certain adult patients to prevent organ rejection after a kidney transplant. Zortress has a different safety profile in these patients.

Afinitor is marketed by East Hanover, N.J.-based Novartis.

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FDA Approves Saphris to Treat Schizophrenia and Bipolar Disorder

The U.S. Food and Drug Administration has approved Saphris tablets (asenapine) to treat adults with schizophrenia, a chronic, severe and disabling brain disorder, and to treat bipolar I disorder in adults, a serious psychiatric disorder that causes shifts in a person's mood, energy, and ability to function.

“Mental illnesses like schizophrenia and bipolar disorder can be devastating to patients and families, requiring lifelong treatment and therapy,” said Thomas Laughren, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “Effective medicines can help people with mental illness live more independent lives.”

The most common symptoms of schizophrenia include hearing voices, or seeing things that are not there, having false beliefs (for example, believing that others are controlling thoughts, reading minds, or plotting harm), and being inappropriately suspicious or paranoid. These thoughts may be terrifying and can cause fearfulness, withdrawal, agitation or violence.

Bipolar I disorder is a chronic, severe, and recurrent psychiatric disorder that causes alternating periods of depression and high, increased activity and restlessness, racing thoughts, talking fast, impulsive behavior, and a decreased need for sleep.

Saphris is in a class of drugs called atypical antipsychotics. All atypical antipsychotics contain a boxed warning, the FDA’s strongest warning. The warning alerts prescribers to an increased risk of death associated with off-label use of these drugs to treat behavioral problems in older people with dementia-related psychosis (a brain disorder that lessens the ability to remember, think, and reason). Saphris is not approved for these patients.

The efficacy of Saphris in treating schizophrenia was studied in three short-term placebo-controlled and active-drug controlled clinical trials. In two of the trials Saphris demonstrated superior efficacy compared to an inactive pill (placebo) in reducing the symptoms of schizophrenia.

The efficacy of Saphris in the treatment of bipolar disorder was studied in two short-term placebo-controlled and active-drug controlled clinical trials in which Saphris was shown to be superior to placebo in treating symptoms of bipolar disorder.

The most common adverse reactions reported by patients in clinical trials being treated for schizophrenia with Saphris were the inability to sit still or remain motionless (akathisia), decreased oral sensitivity (oral hypoesthesia) and drowsiness (somnolence).

The most common adverse reactions reported by patients in clinical trials using Saphris to treat bipolar disorder were drowsiness, dizziness, movement disorders other than akathisia and weight increase.

Saphris is manufactured by Schering-Plough, Kenilworth, N.J.

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FDA Approves Cambia™ for Migraine

(BUSINESS WIRE)--Kowa Pharmaceuticals America, Inc. (KPA), a privately-held specialty pharmaceutical company headquartered in Montgomery, AL, announced today that the U.S. Food and Drug Administration (FDA) has approved Cambia™, a diclofenac-based non-steroidal anti-inflammatory drug (“NSAID”) combined with potassium bicarbonate, for the treatment of acute migraine with or without aura in adults.

Cambia™, formulated with KPA’s patented Dynamic Buffering Technology (DBT), was specifically developed to address widespread unmet needs among patients by offering fast and effective relief of migraine pain. In randomized clinical trials, Cambia™ was shown to be effective not only in migraine pain, but also in treating photophobia (sensitivity to light), phonophobia (sensitivity to sound), and nausea commonly associated with migraine attacks. Cambia™ was also shown to provide statistically significant onset of relief of migraine pain within 15 to 30 minutes.

“The approval is the culmination of over three years of effort from our partners at Applied Pharma Research and the internal team at Kowa,” said William Maichle, Chief Operating Officer of Kowa Pharmaceuticals America, Inc. “Patients and physicians consistently mention rapid pain relief as most important when asked about primary attributes of a migraine medication. We believe Cambia™ addresses these needs and will be a valuable addition to physicians’ migraine armamentarium.”

KPA obtained exclusive U.S. and Canadian marketing rights for Cambia™ from Applied Pharma Research (APR), a Swiss drug delivery and drug development company, in 2005. The product is currently marketed by Novartis Pharma AG, via a license from APR, under the trademarks Voltfast or Catafast in several European countries. KPA and APR have been granted patents that cover Cambia™ through 2026. KPA and APR are currently in the final stages of negotiations with a marketing partner and expect Cambia™ to launch in 4th quarter 2009.

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The Alliance for the Advancement of Adult Stem Cell Therapy and Research Announces Successful Treatment of End-Stage Heart Disease with Stem Cells

(BUSINESS WIRE)--Zannos Grekos, MD, Associate Clinical Professor at Nova Southeastern University, has announced six month follow-up results for a patient treated with adult stem cells in a clinical study of idiopathic dilated cardiomyopathy. The clinical study is a collaborative effort among physicians at Regenocyte Therapeutic, an American stem cell therapy clinic; researchers and scientists from Theravitae, a biotechnology company from Israel; and physicians from the American Institute for Regenerative Medicine, Dominican Republic.

Leonard Narracci, 71 from Venice, Florida, underwent the adult stem cell therapy in October 2008. Since being diagnosed with idiopathic dilated cardiomyopathy and congestive heart failure, Narracci's ejection fraction was severely reduced at 18% (with normal being over 55%). Within three months of the treatment, his ejection fraction improved to 40% and it is now at 51%.

“It goes against traditional theory that we should try to fix damaged heart muscle, but we are generating new heart tissue with impressive results that improve cardiac function and quality of life,” said Dr. Leonel Fernandez Liriano, Professor of Medicine at Pontifical Catholic University School of Medicine (PCUSM), and the head of the cardiology team that treated the patient with adult stem cells.

Grekos states, “After comparing this patient’s echocardiogram and MUGA nuclear scans before and after treatment, we are very pleased to see a profound increase in cardiac function.”

Regenocyte Therapeutic has treated several similar patients and they are demonstrating correlative improvements. Grekos continues, “We have had success in the ischemic heart disease patients since 2006, and it is encouraging to see that the technology can now be applied to other diseases.” Regenocyte Therapeutic is also treating patients with pulmonary hypertension, COPD, kidney disease, peripheral artery disease, and early senile dementia.

Athina Kyritsis, MD, chair of Regenocyte’s Scientific Advisory Board, says the patient results are based upon several years of Regenocyte’s clinical experience in the treatment of numerous degenerative diseases with adult stem cell therapy. “We have had consistent success in generating viable heart tissue and growing new vessels, treating diseases like cardiomyopathy and peripheral vascular disease. With the increased circulation, healing of wounds and improvement in ejection fractions, it seemed a natural progression to approach cardiomyopathy in the same manner. I believe we have only begun to discover what adult stem cells can accomplish in altering the course of diseases until now thought to be untreatable.”

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VeroScience Announces FDA Approval of Cycloset for Treatment of Type 2 Diabetes

(BUSINESS WIRE)--VeroScience, in collaboration with S2 Therapeutics, Inc. (S2), announced yesterday that the U.S. Food and Drug Administration (FDA) approved its first-in-class drug Cycloset™ for the treatment of Type 2 diabetes. Cycloset improves glycemic control across a broad patient population as a monotherapy or as an adjunctive therapy to sulfonylurea, metformin plus sulfonylurea, and single or dual oral hypoglycaemic agent therapies.

Cycloset is the first drug to be approved subsequent to the FDA’s new guidelines that require studies demonstrating that diabetes drugs do not increase cardiovascular risk. A 52 week, double-blind safety trial of 3,000 patients treated with Cycloset did not show an increase in pre-specified and independently adjudicated adverse cardiovascular outcomes—a composite of myocardial infarction, stroke, hospitalization for unstable angina, congestive heart failure, and revascularization surgery—compared to patients taking a placebo (HR 0.58; CI 0.35-0.96).

“For patients newly diagnosed with Type 2 diabetes or those who cannot adequately control their blood sugar with currently available medications, Cycloset provides a completely new approach to treating diabetes,” said J. Michael Gaziano, M.D., Cardiologist, Associate Professor, Division of Aging, Brigham & Women’s Hospital and principal investigator of the Cycloset Safety Trial. “In addition, patients with Type 2 diabetes are at high-risk for cardiovascular events, so it’s important that Cycloset has been demonstrated not to increase the risk of cardiovascular events such as heart attacks, and may actually have potential to lower this risk.”

Cycloset represents a new therapeutic approach in the management of Type 2 diabetes. It is the first drug for patients with diabetes that targets the body’s dopamine activity, a chemical messenger between neurons, or nerve cells, within the nervous system. A dopamine agonist, Cycloset increases dopamine activity. While the specific mechanism by which Cycloset improves glycemic control in humans is unknown, the development of Cycloset for the treatment of Type 2 diabetes was based upon preclinical studies that have shown brain dopamine activity to be low in metabolic disease states and that this factor contributes to multiple metabolic dysfunctions such as insulin resistance—the loss of the body’s ability to respond to the blood sugar lowering effects of insulin—observed in Type 2 diabetes. Moreover, preclinical studies of diabetic animals have shown that treatment with a dopamine agonist as in Cycloset acts upon the central nervous system to reset and improve control of peripheral metabolism.

“This approval is a major milestone for VeroScience and also represents the culmination of many years of intense research and development activities. We’re very pleased that these prodigious efforts will now translate to provide patients with a new approach to treating Type 2 diabetes,” said Anthony H. Cincotta, Ph.D., President and Chief Scientific Officer, VeroScience.

Charles P. Sutphin, President and CEO of S2 Therapeutics, Inc. said, “We are extremely happy to have been able to support and work with VeroScience to bring this diabetes therapy to the U.S. market. With the United States approval, we will collectively initiate efforts to complete applications globally with an immediate focus in Europe and Canada.” S2 Co-chairman and co-founder Brian Schrader said “S2 Therapeutics and VeroScience intend to seek a partner to commercialize Cycloset in order to bring this important new therapy to patients as soon as possible.”

About Cycloset and the Biological Clock

Preclinical studies indicate that while an increase in dopamine activity leads to improvements in diabetes, the time of day of the increased dopamine activity is also important. Studies in diabetic animals have shown that increased dopaminergic activity at a particular time of day is most effective in “resetting” the biological clock neurochemistry to a physiology that improves diabetic dysmetabolism. Taken orally, once-a-day, in the morning, Cycloset provides a single brief pulse of dopamine agonist activity shortly after its administration. Morning Cycloset improves post-prandial glucose without increasing plasma insulin concentrations and the beneficial effects of Cycloset on post-meal glycemic control in patients with Type 2 diabetes are demonstrable many hours after the drug has been substantially cleared from the circulation, for example at lunch and dinner.

The Cycloset Safety Trial, a 3,000 patient, one-year study, demonstrated that Cycloset at doses up to 4.8 mg per day used to treat Type 2 diabetes was not different from placebo regarding the rate of occurrence of all-cause serious adverse events. None of the serious adverse events grouped by System-Organ-Class occurred more than 0.3 percentage points higher with Cycloset than with placebo. Cycloset can cause hypotension, including orthostatic hypotension, and syncope, particularly upon dose initiation or escalation. The primary reason for discontinuation from clinical trials of Cycloset was nausea, which was mild to moderate and transient during the beginning of therapy.

“Cycloset represents a new treatment paradigm for Type 2 diabetes. The clinical development of Cycloset involved the collection of a vast amount of safety data prior to the drug’s approval. The information compiled to date has demonstrated that this novel therapy is both safe and effective in treating Type 2 diabetes alone or in combination with other drugs used to treat Type 2 diabetes,” said Richard Scranton M.D., M.P.H., Chief Medical Officer, VeroScience.

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Georgia State Study First to Pinpoint Why Analgesic Drugs May be Less Potent in Females than in Males

Investigators at Georgia State University’s Neuroscience Institute and Center for Behavioral Neuroscience are the first to identify the most likely reason analgesic drug treatment is usually less potent in females than males. This discovery is a major step toward finding more effective treatments for females suffering from persistent pain.

“Opioid-based narcotics (such as morphine) are the most widely prescribed therapeutic agents for the alleviation of persistent pain; however, it is becoming increasingly clear that morphine is significantly less potent in women compared with men. Until now, the mechanism driving the phenomenon was unknown,” said Anne Murphy, a Georgia State Professor of Neuroscience and member of the Center for Behavioral Neuroscience, who conducted the research with Dayna Loyd.

Murphy recently solved the mystery with findings printed in the December issue of The Journal of Neuroscience that show that previously reported differences in morphine’s ability to block pain in male versus female rats are most likely due to sex differences in mu-opioid receptor expression in a region of the brain called the periaqueductal gray area (PAG).

Located in the midbrain area, the PAG plays a major role in the modulation of pain by housing a large population of mu-opioid receptor expressing neurons. Morphine and similar drugs bind to these mu-opioid receptors analogous to a ‘lock and key’ and, ultimately, tell the brain to stop responding to pain signals to the nerve cells resulting in the reduced sensation of pain.

Using a series of anatomical and behavioral tests, Murphy and Loyd were able to determine that male rats have a significantly higher level of mu-opioid receptors in the PAG region of the brain compared with females. This higher level of receptors is what makes morphine more potent in males because less drug is required to activate enough receptors to reduce the experience of pain. Interestingly, when they used a plant-derived toxin to remove the mu-opioid receptor from the PAG, morphine no longer worked, suggesting that this brain region is required for opiate-mediated pain relief.

Additional tests also found females reacted differently to morphine depending on the stage of their estrous cycle. These findings indicate that steroid hormones may affect mu-opioid receptor levels in the region of the PAG that are essential for analgesia and also suggest that the actions of morphine are estrous stage-dependent.

“Interestingly, sex is not the only factor that has been shown to affect the potency of various pharmacological agents. Recent studies have reported an influence of age and ethnicity, and further argue for the inclusion of a wide range of study subjects in pain management research,” Murphy said. “In addition, despite the rapidly mounting evidence regarding the limitations of opiates in treating persistent pain, opioid-based drugs remain the primary pharmacological tool for pain management. Clearly additional research with the inclusion of female subjects needs to be devoted to determining a more potent treatment for persistent pain in women.”

Murphy’s work was supported by grants from the National Institutes of Health.

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