UPDATE:FDA: Proposed Epilepsy Drug Potiga Effective As Add-On Treatment
August 09 2010 - 2:32PM
Dow Jones News
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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