Mayo Clinic Finds Seizure Generation in Brain is Isolated from Surrounding Brain Regions

Mayo Clinic researchers found that the part of the brain generating seizures in individuals with epilepsy is functionally isolated from surrounding brain regions. The researchers hope this finding could be a clinical biomarker to help identify individuals with abnormal brain function. This study was presented at the American Epilepsy Society's annual meeting in San Antonio on Dec. 4.

Epilepsy is a disorder characterized by the occurrence of two or more seizures. It affects almost 3 million Americans.

"The synchronization of local and distributed neuronal assemblies underlies fundamental brain processes like perception, learning and cognition," says Gregory Worrell, M.D., Ph.D., a Mayo Clinic epileptologist and an author of this study. "In neurological disease, neuronal synchrony can be altered, and in epilepsy the synchrony plays an important role in the generation of seizures."

Mayo Clinic researchers investigated neuronal synchrony by studying intracranial EEG (electroencephalogram) recordings from patients with epilepsy and control subjects with facial pain. Researchers discovered that the control patients had greater average synchrony than patients with focal epilepsy (when seizures are produced in a small part of the brain, not the entire brain). When implanted electrode pairs bridged seizure-generating brain and other brain regions, the synchrony was significantly less than between other electrode pairs in the epileptic brain and the control brain. The team also found that with greater activity in the seizure-generating region, there was less synchrony with neighboring tissue outside that region.

"Our study shows us that the part of the brain generating seizures is isolated from the surrounding brain regions," says Dr. Worrell. "This finding could serve as a clinical biomarker of an abnormal brain, and it can also be useful in epilepsy surgery and brain stimulation treatments, as well as helping us understand how seizures are generated." Other scientists involved in this research include C. Warren, Ph.D.; S. Hu; S. Stead, M.D., Ph.D.; B. Brinkmann, and M. Bower, Ph.
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FDA: Aseptic Meningitis Risk with Use of Seizure Drug Lamictal

/PRNewswire/ -- The U.S. Food and Drug Administration today warned that the drug Lamictal (lamotrigine), approved to treat seizures and bipolar disorder, can cause aseptic meningitis, an inflammation of the protective membranes (meninges) that cover the brain and spinal cord not caused by bacterial infection.

The agency is working with the drug's manufacturer, GlaxoSmithKline, to update the prescribing information and patient medication guide to include this risk.

Aseptic meningitis has a number of causes including, but not limited to, viruses, toxic agents, some vaccines, autoimmune diseases, and certain medications, including Lamictal. Symptoms can include headache, fever, chills, nausea, vomiting, stiff neck and sensitivity to light. Hospitalization may be required.

In suspected cases of meningitis, the underlying cause should be rapidly diagnosed so that treatment can be promptly initiated. Discontinuation of Lamictal should be considered if no other clear cause of meningitis is identified.

"Aseptic meningitis is a rare but serious side effect of Lamictal use," said Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. "Patients that experience symptoms should consult their health care professional immediately."

The FDA became aware of the association between Lamictal and aseptic meningitis through routine adverse event monitoring and communications with the drug's manufacturer. Since the drug's approval in December 1994 through November 2009, there were 40 cases of aseptic meningitis identified in patients taking Lamictal. The symptoms were reported to occur within one to 42 days after starting Lamictal. Thirty-five of the 40 patients required hospitalization. In most cases, symptoms ended after Lamictal was discontinued. In 15 cases, symptoms, often more severe, returned when patients restarted the drug.

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Sabril Approved by FDA to Treat Spasms in Infants and Epileptic Seizures

Sabril (vigabatrin) Oral Solution has been approved by the U.S. Food and Drug Administration to treat infantile spasms in children ages 1 month to 2 years. Sabril is the first drug in the United States approved to treat the disorder, characterized by a severe type of seizure that usually appears in the first year of life, typically between ages 4 months and 8 months. The disorder can be debilitating because of the frequency of difficult-to-control daily seizures.

Sabril (vigabatrin) Tablets have been approved for adult use in combination with other medications to treat complex partial seizures that have not responded adequately to previous drug therapies.

“Seizures can cause impaired nervous system function and reduced quality of life,” said Russell Katz, M.D., director of the Division of Neurology Products at the FDA’s Center for Drug Evaluation and Research. “Infantile spasms in children this young are very serious and this approval provides these patients and their parents a treatment option.”

Infantile spasms consist primarily of a sudden bending forward of the body with stiffening of the arms and legs; some children arch their backs as they extend their arms and legs. Spasms tend to occur upon awakening or after feeding, and often occur in clusters of up to 100 spasms. Infants may have dozens of clusters and several hundred spasms per day. Many underlying disorders, such as birth injury, metabolic disorders, and genetic disorders can give rise to spasms, making it important to identify the underlying cause. In some children, no cause can be found.

Epilepsy is a neurological condition that produces disturbances in the normal electrical functions of the brain, causing people to have recurring seizures. Seizures happen when nerve cells, or neurons, in the brain send out the wrong signals. People may have strange sensations and emotions or behave strangely. They may have violent muscle jerking, which may be repetitive, or lose consciousness.

Damage to vision is an important safety concern with the use of Sabril. The drug will have a boxed warning to alert health care professionals to this risk of a progressive loss of peripheral vision with potential decrease in visual acuity. The risk of vision damage may increase based on the dosage and duration of use, but even the lowest doses of Sabril can cause vision damage. Periodic vision testing is required for those taking Sabril. Because of the risk of permanent vision damage, the drug will be available only through a restricted distribution program.

Sabril was designated as an orphan drug by the FDA for use in treating infantile spasms. A drug is eligible for orphan drug designation if it is intended to treat a disease or condition that affects less than 200,000 people in the United States. Orphan drug status provides the company with financial incentives to promote the development of a drug to treat a rare disease or condition.

Sabril is made by Lundbeck Inc. of, Deerfield, Ill.

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U.S. Marshals Seize Drug Products Manufactured by Caraco Pharmaceutical Laboratories Ltd.

U.S. Marshals, at the request of the Food and Drug Administration, today seized drug products manufactured by Caraco Pharmaceutical Laboratories Ltd. (Caraco), at the company’s Michigan facilities in Detroit, Farmington Hills, and Wixom. The seizure also includes ingredients held at these same facilities. “The FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our good manufacturing practice requirements,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Compliance with these standards prevents harm to the public.”

This action follows Caraco’s continued failure to meet the FDA’s current Good Manufacturing Practice (cGMP) requirements, which assure the quality of manufactured drugs. Through this seizure, the FDA seeks to immediately stop the firm from further distributing drugs until there is assurance that the firm complies with good manufacturing requirements.

Since January 2009, Caraco has initiated voluntary recalls of drug products to protect the public from potentially defective medications. The recalls involved manufacturing defects, including oversized tablets and possible formulation error.

The FDA has determined that the seizure of Caraco's drugs may create a shortage of one product, choline magnesium trisalicylate oral tablets, which are commonly used as pain relievers. The FDA recommends in the event of a shortage, that health care providers consider alternative treatments that are safe and effective. Consumers and health care providers who are unable to obtain any of Caraco’s products should contact the FDA Drug Shortage Program by e-mail at drugshortages@fda.hhs.gov, or by telephone at 888-463-6332 or 301-796-3400.

The FDA’s most recent inspection of Caraco, completed in May 2009, found unresolved violations of cGMP requirements. Today’s seizure is intended to lead to major changes at Caraco’s facilities.

If the FDA identifies further significant problems, which pose risks to patient safety with any Caraco drug products on the market, the agency will take appropriate additional regulatory action and immediately notify the public.

"The FDA will continue to take swift, aggressive enforcement action when firms are identified as being in violation of our manufacturing requirements," said Michael Chappell, FDA acting associate commissioner for regulatory affairs.

Seizure of drug products is an effective remedy when there is evidence of continued poor compliance with cGMPs. Following a drug product seizure, companies often agree to a wide range of changes and improvements to their drug manufacturing practices at their facilities.

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FDA Approves Generic Topamax to Prevent Seizures

The U.S. Food and Drug Administration has approved the first generic versions of Topamax tablets (topiramate) to prevent seizures.

"Generic drugs undergo a rigorous scientific review to ensure they will provide patients with the same dose of high quality, safe and effective active ingredient as the name brand product," said Gary Buehler, director of the Office of Generic Drugs in the Center for Drug Evaluation and Research. "The FDA is committed to providing access to safe and effective generic drugs as soon as the law permits when a brand name drug’s patents and exclusivities expire."

Topiramate tablets in several different strengths have been approved to be marketed by the following firms: Roxane Laboratories Inc., Par Pharmaceuticals Inc., Mylan Pharmaceuticals Inc., Barr Laboratories Inc., TEVA Pharmaceuticals USA, Ranbaxy Laboratories Ltd., CIPLA Ltd., Glenmark Generics Ltd., Cobalt Laboratories, Apotex Inc., Zydus Pharmaceuticals USA, Aurobindo Pharma Ltd., Torrent Pharmaceuticals Ltd., Invagen Pharmaceuticals Inc., Unichem Laboratories Ltd., Sun Pharmaceuticals Ltd. and Pliva Hrvatska.

Prescribing information, or labeling, for generic topiramate will differ from the innovator drug, Topamax, because some uses of Topamax continue to be protected by patents and exclusivity.

The labeling for Topamax and generic topiramate contains an important safety warning about metabolic acidosis, a condition associated with excessive acid in the blood, which can cause symptoms such as tiredness, loss of appetite, irregular heartbeat, and impaired consciousness. Health care professionals should perform a blood test to monitor the level of a patient’s serum bicarbonate.

The use of topiramate has been associated with serious eye problems, such as a sudden decrease in vision and a blockage of fluid in the eye causing increased pressure in the eye. Patients taking topiramate should contact their health care professional immediately if they have a loss in vision or experience eye pain. These problems can lead to blindness if not treated right away.

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FDA Approves New Drug to Treat Severe Form of Epilepsy

The U.S. Food and Drug Administration has approved a new drug, Banzel (rufinamide), for use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome.

"This approval offers another treatment option for patients who suffer from these debilitating, severe seizures," said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research.

Lennox-Gastaut syndrome is a severe form of epilepsy that usually begins before 4 years of age, and can be caused by brain malformations, severe head injury, central nervous system infection and inherited degenerative or metabolic conditions. In 30-35 percent of cases, no cause can be found. Patients may have periods of frequent seizures mixed with brief, relatively seizure-free periods; and suffer from varying types of seizures including tonic (stiffening of the body, upward deviation of the eyes, dilation of the pupils, and altered respiratory patterns), atonic (brief loss of muscle tone and consciousness, causing abrupt falls), atypical absence (staring spells), and myoclonic (sudden muscle jerks).

Most children with Lennox-Gastaut syndrome experience some degree of impaired intellectual functioning or information processing, along with developmental delays and behavioral disturbances.

In a single four-month clinical trial studying patients 4 to 30 years old, patients taking Banzel had improved seizure control when compared to those taking placebo. The observed effect was approximately a 41 percent reduction of tonic plus atonic seizure frequency over placebo and 20 percent reduction of total seizure frequency over placebo. In addition, overall improvement was reported as measured by a parent/guardian evaluation.

Common adverse reactions reported by patients using Banzel in clinical trials included headache, dizziness, fatigue, drowsiness, gait disturbance, double-vision, nausea and vomiting. Banzel's labeling will include a warning that antiepileptic drugs increase the risk of suicidal thoughts or behaviors in patients taking the drug for any indication. Patients taking antiepileptic drugs should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and unusual changes in mood or behavior. This warning is based on the results of analyses performed by the FDA on nearly 200 controlled clinical trials with 11 FDA-approved antiepileptic drugs. Banzel was not included in these analyses, but the results are considered to apply to all chronically administered antiepileptic drugs, including Banzel. As discussed at a July 2008 public advisory committee meeting, the FDA is working with manufacturers of all antiepileptic drugs to include similar warning statements in prescribing information. The FDA is requiring that a patient Medication Guide be given to patients and caregivers when Banzel is dispensed. The Medication Guide will describe the risk of suicidal thoughts and behavior associated with the class of antiepileptic drugs.

Banzel is manufactured by Eisai Medical Research Inc., Woodcliff Lake, N.J.

Banzel was granted orphan drug designation by the FDA. A drug is eligible for orphan drug designation if it is intended to treat a disease or condition that affects fewer than 200,000 people in the United States. This designation can also be extended to drugs for diseases or conditions that affect a larger number of patients if there is no reasonable expectation that the cost of developing such medications and making them available will be recovered from sales.

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Keppra XR(TM) Approved for Sale in US by FDA

Epilepsy is a chronic neurological disorder affecting approximately three million people in the US-making it more common than multiple sclerosis and Parkinson's disease combined. It is caused by abnormal, excessive electrical discharges of the nerve cells, or neurons, in the brain. Epilepsy is characterized by a tendency to have recurrent seizures and defined by two or more unprovoked seizures. There are many different seizure types and epileptic syndromes. Forty percent of patients taking only one AED continue to experience seizures, and approximately 30% of patients taking adjunctive therapy continue to experience seizures. This highlights the ongoing need for the development of new AEDs. For more information about epilepsy, visit www.epilepsyfoundation.org, www.epilepsy.com, or www.epilepsyadvocate.com.

PRNewswire --- UCB announced today that the U.S. Food and Drug Administration (FDA) has approved Keppra XR(TM) (levetiracetam extended-release tablets) for use as an add-on to other antiepileptic treatments for people with partial-onset seizures who are 16 years of age and older. Keppra XR(TM) is expected to be available in U.S. pharmacies at the end of September 2008.

The goal of therapy with antiepileptic drugs (AED) is freedom from seizures and minimal side effects. While many people with epilepsy are successfully treated with one or more of the currently available antiepileptic drugs, a significant percentage still live with uncontrolled seizures or intolerable side effects.

"With solid clinical trial data supporting Keppra XR(TM) efficacy and tolerability, this once-daily antiepileptic drug can play an important role in treating people with epilepsy," said lead investigator Dr. Jukka Peltola, Department of Neurology, Tampere University Hospital, Finland. "We found in the clinical trial that Keppra XR(TM) provided significant partial onset seizure control in once-daily dosing when added to other antiepileptic drugs and that it was generally well-tolerated."

Important Safety Information

Keppra XR(TM) extended-release tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in patients 16 years of age and older with epilepsy.

Keppra XR(TM) causes somnolence, dizziness, and behavioral abnormalities. The most common adverse reactions observed with Keppra XR(TM) in combination with other AEDs were somnolence and irritability.

The adverse reactions that may be seen in patients receiving Keppra XR(TM) are expected to be similar to those seen in patients receiving immediate- release Keppra(R) tablets.

Keppra(R) immediate-release tablets cause somnolence and fatigue, coordination difficulties, and behavioral abnormalities (e.g., psychotic symptoms, suicidal ideation, and other abnormalities), as well as hematological abnormalities. In adults experiencing partial onset seizures, the most common adverse reactions observed with Keppra(R) in combination with other AEDs were somnolence, asthenia, infection and dizziness.

Keppra XR(TM) should be gradually withdrawn to minimize the potential of increased seizure frequency.

Dosing must be individualized according to the patient's renal function status. The dosage should be reduced in patients with impaired renal function receiving Keppra XR. In patients with end stage renal disease on dialysis, it is recommended that immediate-release Keppra(R) be used instead of Keppra XR(TM).

For full prescribing information, please see www.KeppraXR.com.

In order to ensure patient access to this valuable medication in the U.S., UCB is initiating a co-pay support program. For more information, contact U.S. UCB Medical Information at 1-866-822-0068 (press 9).

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Federal Agents Seize more than $24 Million in Unapproved New Drugs

Representatives of the U.S. Food and Drug Administration and the U.S. Marshals Service today seized $24.2 million worth of unapproved new drugs from KV Pharmaceutical Company of St. Louis, Mo. Agents acted after United States Attorney Catherine L. Hanaway filed a civil forfeiture suit and obtained a warrant to seize the unapproved new drug products being made by KV Pharmaceutical.

"American consumers are entitled to have safe and effective drugs," said Hanaway.

The seizure followed an inspection of several of the company's plants where FDA investigators found that the company was not complying with an FDA enforcement notice as well as manufacturing unapproved new drugs such as products for cough, cold, topical wound healing, skin bleaching, and gastrointestinal conditions, as well as narcotic drug products.

"The FDA is committed to taking enforcement action against firms that circumvent the drug approval process," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research (CDER). "Consumers need to be confident that the drugs and medical products they use are safe and effective, and the FDA will take the necessary measures to ensure safety and effectiveness throughout the lifecycle of the product, including keeping the product from reaching the marketplace."

In a routine inspection of KV Pharmaceutical's facilities in early 2008, the FDA found the company was violating its May 29, 2007, notice (72 FR 29517) requiring companies to stop manufacturing all timed-release drug products containing guaifenesin, including combination drug products in which guaifenesin is in immediate release form, but another ingredient in the combination drug product is in timed-release form, because they are unapproved new drugs. FDA took the action as part of its effort to ensure that all drugs marketed in the United States have the required FDA approval and that they are safe, effective, of good quality, and are appropriately labeled. For products in timed-release form, FDA approval is also necessary to make sure that the product releases its active ingredients at the correct rate. Improperly manufactured timed-release products may release the active ingredients too quickly, too slowly, or not at all, making the product unsafe or ineffective.

The FDA required companies to stop manufacturing the affected products before August 27, 2007, and to stop shipping the products before November 26, 2007. KV Pharmaceutical continued to manufacture and ship these unapproved new drugs after the cessation dates.

The inspection also exposed the company's manufacturing and distribution of other unapproved drug products. Today's action addresses numerous unapproved drug products manufactured and distributed by the company.

The following drug products were seized and will be destroyed:

• PhenaVent Capsules
• PhenaVent LA Capsules
• PhenaVent PED Capsules
• Ethezyme Papain-Urea Ointment
• Ethezyme 650 Papain-Urea Ointment
• Ethezyme 830 Papain-Urea Ointment
• Hista-Vent DA Tablets
• Meperidine/Promethazine Capsules
• Pseudovent Capsules
• Pseudovent 400 Capsules
• Pseudovent PED Capsules
• Tri-Vent DM Syrup
• Tri-Vent DPC Syrup
• Hydro-Tussin DM Liquid
• Hydro-Tussin CBX Syrup
• Hydro-Tussin DHC Syrup
• Hydro- Tussin EXP Syrup
• Hydro-Tussin HD Syrup
• Hyoscyamine Sulfate Sublingual Tablets
• Hydroquinone 4% Cream
• Hydroquinone 4% Cream with Sunscreen
• Bromfenex Extended Release Capsules
• Bromfenex PD Extended Release Capsules

The seized drugs had been held under embargo by the state of Missouri. Since the time of the embargo, KV Pharmaceutical has been cooperating with FDA officials.

"The FDA will take action against companies that continue to manufacture or market an unapproved product after the marketing or distribution cessation date," said Deborah M. Autor, director of the FDA's Office of Compliance within CDER. "When a company does not heed a cessation date relating to a specific product, the FDA will take enforcement action relating to the company's other unapproved drugs."

In June 2006, the FDA issued a guidance document titled, "Marketed Unapproved Drugs—Compliance Policy Guide (CPG)." This CPG makes clear that companies may not market drugs that require approval without first establishing, through applications for approval, that the products are safe and effective.

The FDA encourages consumers who may have these products to contact their health care professional about FDA-approved treatments and discard these products.

FDA Approves First Generic Divalproex Sodium to Treat Seizures, Migraine Headaches and Bipolar Disorder

The U.S. Food and Drug Administration today approved the first generic versions of Depakote delayed-release tablets (divalproex sodium). Depakote is approved by the FDA for the treatment of seizures, bipolar disorder and migraine headaches.

"Generic drugs undergo a rigorous scientific review to ensure that they will provide the patient with the same amount of high quality, safe and effective drug as the name brand product," said Gary J. Buehler, director of the FDA's Office of Generic Drugs. "This approval provides an additional treatment option for patients who suffer from epilepsy, bipolar disorder and migraines."

Generic divalproex sodium will have the same safety warnings as Depakote, including a Boxed Warning that cautions about the risk of liver damage (hepatotoxicity), including fatalities, and pancreatitis, or an inflamed pancreas, including fatal cases. The Boxed Warning also highlights the risk of birth defects (teratogenicity), including neural tube defects.

The following firms have received approval to market divalproex sodium delayed-release tablets: Sun Pharmaceutical Industries Ltd., Mumbai, India; Genpharm Inc., Ontario, Canada; Nu-Pharm Inc., Ontario, Canada; Upsher-Smith Laboratories, Maple Grove, Minn.; Sandoz Inc., Broomfield, Colo.; TEVA Pharmaceuticals USA, North Wales, Penn.; Dr. Reddy’s Laboratories, Hyderabad, India; and Lupin Limited, Mumbai, India.

Epilepsy.com Provides Seizure Information to Help Educate the Public

BUSINESS WIRE--Epilepsy.com, an award-winning patient care site, is providing accurate information regarding epilepsy and seizures to the public and the media in the wake of the reported seizure that hospitalized Senator Edward M. Kennedy (D-Mass) on May 17. The website www.epilepsy.com of which Harvard Medical School Professor of Neurology, Steven C. Schachter, MD, is Editor-in-Chief, is an online resource for more than 200,000 unique visitors and one million page views per month. Dr. Schachter is also Director of Research for the Department of Neurology at Beth Israel Deaconess Medical Center in Boston. We present here information and links to epilepsy.com that should be helpful in understanding this event.

What is a seizure? A seizure is a sudden surge of electrical activity in the brain that usually affects how a person feels or acts for a short time (http://my.epilepsy.com/101/ep101_seizure). Seizures are not a disease in themselves. Instead, they are a symptom of many different disorders that can affect the brain. Seizures can range from hardly noticeable to a convulsion (http://my.epilepsy.com/epilepsy/types_seizures).

What is epilepsy? Epilepsy is a neurological condition that affects the brain. Epilepsy is also known as a seizure disorder. Epilepsy is usually diagnosed after a person has had at least two seizures that were not caused by some non-neurological condition that secondarily affects the brain, such as extremely low blood sugar (http://my.epilepsy.com/101/ep101_epilepsy). Although epilepsy is often considered a disorder of childhood, it can begin at any age. The rate of newly diagnosed epilepsy is actually higher in seniors (elderly people) than in middle-aged adults.

What tests are usually performed when a person has their first seizure? Because there are many possible causes of seizures, a thorough medical history is obtained and a variety of medical tests are performed to determine the cause, if possible, and to evaluate the risk of further seizures. Among the tests typically done are blood tests, a test of the brainwaves called an electroencephalogram (EEG), and brain imaging tests such as CT and MRI scans (http://my.epilepsy.com/101/101_diagnosis). Very often, these tests do not reveal a cause.

What are the possible causes of seizures and epilepsy? There is a long list of possible causes (http://my.epilepsy.com/101/ep101_risks) because many of the conditions that affect brain function can possibly cause a seizure. The cause of recurrent seizures (epilepsy) that begin in later life cannot be determined in about half of the cases. Of those in whom the cause can be determined, the most common cause is strokes, including small ones that did not cause other symptoms.

When is treatment usually begun? If the medical evaluations and tests determine that a person has had more than one seizure, or that he or she is at substantial risk for a second seizure due to an identified problem with brain function, then therapy with medicines called “anticonvulsants” or “antiepileptic drugs” may be started (http://my.epilepsy.com/epilepsy/treatment; http://my.epilepsy.com/info/seniors_effectsmed).

What is appropriate first aid for seizures? Here are a few things you can do to help someone who is having a seizure of any kind (http://my.epilepsy.com/epilepsy/firstaid):

• Stay calm.
• Prevent injury. Move anything away that could harm the person if he or she struck it.
• Pay attention to the length of the seizure.
• Make the person as comfortable as possible.
• Keep onlookers away.
• Do not hold the person down.
• Do not put anything in the person's mouth. Contrary to popular belief, a person having a seizure is incapable of swallowing their tongue so don’t put your fingers or any object into the mouth of someone having a seizure.
• Do not give the person water, pills, or food until fully alert.
• If this is the first known seizure for the person, or it lasts more than five minutes, or there is an apparent injury, call 911.
• Be sensitive and supportive, and ask others to do the same.

The mission of epilepsy.com is to inform and empower patients and families facing newly diagnosed epilepsy or those struggling with epilepsy that has resisted treatment. Epilepsy.com is the home of the Epilepsy Therapy Project. Co-founded by Chairman Warren Lammert, it is a not-for-profit corporation dedicated to a singular focus: overcoming the funding gaps and roadblocks that slow the progress of new epilepsy therapies from the lab to the patient.