Epilepsy Therapy Project President Joyce Cramer to Provide Critical Perspective and New Insights into Suicidality Incidence

Incidence of Suicidality Relates to Pre-existing Psychiatric Disorders

Joyce A. Cramer, President of the Epilepsy Therapy Project (ETP), will be presenting today, Thursday, July 10, 2008, before the US Food and Drug Administration’s (FDA) Joint Meeting of the Peripheral and Central Nervous Drugs Advisory Committee and the Psychopharmacologic Drugs Advisory Committee on the incidence of suicidality and correlation to pre-existing psychiatric disorders among patients being treated with anti-epilepsy therapeutics. In her comments, Ms. Cramer will both discuss the unintended consequences of proposed FDA actions and also new insights into pre-existing psychiatric disorders and the recognition of co-morbidities that predate the prescribing of seizure disorder medications.

The Joint Meeting of these FDA Advisory Committees has been convened today to discuss results of an FDA meta analysis and issues related to antiepileptic (AED) drugs and suicidality. In her testimony, Ms. Cramer will present the position of the Epilepsy Therapy Project and its scientific advisory board, which does not concur with the FDA findings on the risk of suicidality related to antiepileptic drugs as a class or with the proposition that a “black box” warning on the labels of this class of drugs is warranted. In addition, Ms. Cramer will propose that such a warning may have serious clinical health consequences for the epilepsy patient population and for the support of future epilepsy drug development. In her presentation, Ms. Cramer will introduce top-line clinical observations from a recently completed study by the VA Health Services Research Group, demonstrating that the risk of suicidality can be diagnosed prior to and separately from antiepileptic drug therapy, as well as a clear linkage to pre-existing psychiatric disorders among certain patients. The full results of this case-controlled clinical study of 112,000 patients who have been diagnosed and newly treated with FDA-approved AEDs is expected to be published in a major peer-reviewed journal in 2008.

Key highlights of her discussion:

• The Epilepsy Therapy Project is concerned that current media coverage of suicidality will confuse patients and potentially physicians on treatment decisions.
• A "black box" warning for the entire class of antiepileptic drugs may have serious consequences for patient compliance and the management of seizure conditions.
• ETP urges patients and families to contact their physicians before stopping an epilepsy medication because this may lead to uncontrolled seizures (for additional information, please visit www.epilepsy.com.)
• Top-line findings from the Department of Veterans Affairs demonstrate that suicidality in epilepsy is linked to co-morbid psychiatric diagnoses -- not the medications. These data suggest that the FDA data analyses may not be replicable in other large carefully-defined cohorts.
• There needs to be a clear understanding and message from the FDA that any such psychological tendency is best diagnosed and understood prior to starting treatment with an AED.
• One-third of patients diagnosed with seizure conditions are not helped by approved medications. ETP is focused on accelerating the discovery and development of new drugs, and not increasing the number of patients who must live with uncontrolled seizures.

Media may call ETP for more information or comment. For more information on epilepsy, please visit www.epilepsy.com.

Joyce A. Cramer, ETP President, Associate Research Scientist, Yale University School of Medicine, Department of Psychiatry

Warren Lammert, ETP Chairman and Co-founder

Orrin Devinsky, M.D., ETP Vice President for Development, Professor of Neurology, Neurosurgery, and Psychiatry at NYU School of Medicine

Jacqueline French, M.D., ETP Vice President for Research, Professor of Neurology and Co-Director, Pennsylvania Epilepsy Center, University of Pennsylvania

Steven Schachter, M.D., ETP Vice President for Medical Information, Editor-in-Chief, epilepsy.com, Professor of Neurology, Harvard Medical School, Director of Research Beth Israel Deaconess Medical Center Department of Neurology

About the Epilepsy Therapy Project

The Epilepsy Therapy Project is a non-profit organization whose mission is to advance new therapies for people living with epilepsy. Founded in 2002 by a group of parents, distinguished physicians and researchers, the Epilepsy Therapy Project supports the commercialization of new therapies through direct grants and investments in promising academic and commercial projects. The organization has raised over six million dollars towards its mission. Learn more at www.epilepsy.com.

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