UPDATE:FDA: Proposed Epilepsy Drug Potiga Effective As Add-On Treatment

The Food and Drug Administration said Monday a proposed epilepsy drug called Potiga being developed by Valeant Pharmaceuticals International (VRX) and GlaxoSmithKline PLC (GSK, GSK.LN) appears to be effective.

However, the agency raised concerns about urinary side-effects, saying the main safety concern seen with Potiga was urinary retention, or in the inability to urinate.

Potiga, also known by its generic name ezogabine, faces a review by the FDA's Peripheral and Central Nervous System Drugs Advisory Committee on Wednesday. The FDA released a review of Potiga on Monday in advance of the meeting. The product is designed to treat adults with partial onset seizures who aren't adequately treated with other medications. Potiga would be added to other medications.

In a briefing memo, the FDA said three clinical trials looking at different doses of Potiga showed it helped reduce the number of seizures in patients compared to those who weren't receiving the drug when given three times a day.

The FDA said most cases of urinary retention were reversible. Other side-effects included dizziness and fatigue. The agency said it is interested in the advisory panel's view of urinary safety signals and whether the companies' plans to monitor patients for urinary retention is adequate.

The panel will be asked to vote on a series of questions about the safety and effectiveness of Potiga. The outcome of the votes will amount to a recommendation about whether the panel thinks the FDA should approve Potiga. The agency isn't required to follow the advice of its advisory panels but usually does.

In a background document also posted to FDA's website, Valeant said nearly one-third of epilepsy patients don't respond to currently available medications or experience significant drug side-effects. Valeant said Potiga has shown "convincing" effectiveness "with an acceptable safety profile."

Epilepsy is a brain disorder, often marked by seizures, in which clusters of nerve cells, or neurons, in the brain sometimes signal abnormally.

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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