FDA Panel Backs Proposed Epilepsy Drug From Glaxo, Valeant

A Food and Drug Administration panel Wednesday backed a proposed epilepsy drug called Potiga developed by Valeant Pharmaceuticals International (VRX) and GlaxoSmithKline PLC (GSK, GSK.LN).

The panel unanimously said the companies provided data showing the product was effective as an add-on treatment in certain epilepsy patients. The panel also said it believed patients could be monitored for urinary-side effects, which the FDA said is the main safety concern with the product.

Specifically, 11 members of the panel said urinary retention could by "mitigated by patient monitoring" while two people abstained from voting on that question.

Potiga, also known by its generic name ezogabine, is being reviewed Wednesday by the FDA's Peripheral and Central Nervous System Drugs Advisory Committee. The positive votes on its effectiveness and safety amount to a recommendation that the FDA approved the product. The FDA usually follows the advice of its panels of non-FDA medical experts but is not required to.

Potiga is designed to treat adults with partial onset seizures who aren't adequately treated with other medications. Potiga would be added to other medications.

Valeant is being acquired by Canadian pharmaceutical firm Biovail Corp. (BVF) in a deal that's expected to close by the end of the year.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com

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