FDA panel recommends approval of new anti-epileptic drug

posted on:
September 1, 2010


A  Food and Drug Administration (FDA) advisory board has given a “thumbs-up” to GlaxoSmithKline’s new epilepsy drug Potiga (ezogabine), saying three clinical trials with patients taking the drug show that it effectively controls seizures when used as an add-on treatment in certain epilepsy patients. The main safety concern with Potiga is urinary side effects, which 11 members of the advisory panel said could be mitigated by patient monitoring. Two advisors abstained from voting on that issue.

Potiga is designed to treat adults with partial onset seizures who aren’t adequately treated with other medications. Reported side effects include inability to urinate, dizziness and fatigue. The FDA is not required to follow the recommendation of its advisory board, however it usually does. If approved for marketing in the United States, Potiga stands to make millions in a market that brought in about $13 billion in global sales last year alone.

Seventeen AEDs are FDA-approved for the treatment of seizures, yet one-third of epileptics cannot control their disorders with the medications currently available. Medications also carry side effects that can be harmful for neurological patients who tend to be more sensitive to inactive ingredients and subtleties between brand name and generic formulations of the same drug. If approved, Potiga would be used as a second-line treatment for patients whose seizures are not adequately controlled with currently available AEDs.

Potiga was developed through a partnership between GlaxoSmithKline and Valeant Pharmaceuticals International. Valeant is being acquired by Canadian pharmaceutical firm Biovail Corp., a deal expected to close by the end of 2010. 

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