Reuters: Hot Stocks: UPDATE 1-FDA advisers vote to reject approval of Depomed's menopause drug

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UPDATE 1-FDA advisers vote to reject approval of Depomed's menopause drug Mar 4th 2013, 17:55 Tweet Share this Email Print Mon Mar 4, 2013 12:55pm EST (Updates with details) March 4 (Reuters) - Advisers to the U.S. Food and Drug Administration on Monday recommended the agency reject a drug made by Depomed Inc to reduce the frequency and severity of hot flashes associated with menopause. The panel of advisers voted 13-1 that company failed to prove convincingly that the drug worked. They voted 12-2 that its efficacy, when balanced against risk, did not warrant approval. The drug, Sefelsa, is a long-acting version of the epilepsy drug gabapentin. A short-acting version of gabapentin made by Pfizer Inc and marketed as Neurontin was approved in 1993. Clinical trials of Depomed's drug showed it only partially reduced the frequency and severity of hot flashes while side effects included dizziness, sleepiness, headache and nausea. Gabapentin has also been shown to increase the risk of suicide. The FDA does not have to follow the recommendations of its advisory panels but it generally does. Sefelsa is one of two drugs designed to reduce hot flashes being considered on Monday. The second is a drug from a unit of Hisamitsu Pharmaceutical Co Inc that comprises a low dose version of the antidepressant paroxetine. Depomed's drug was approved in the United States in 2011 to treat shingles-related pain and is marketed under the brand Gralise. Depomed's shares were halted pending the panel's vote at $6.52 on Nasdaq. (Reporting By Toni Clarke; Editing by Gerald E. McCormick and Sofina Mirza-Reid) Related Quotes and News Company Price Related News Tweet this Link this Share this Digg this Email Reprints We welcome comments that advance the story through relevant opinion, anecdotes, links and data. If you see a comment that you believe is irrelevant or inappropriate, you can flag it to our editors by using the report abuse links. Views expressed in the comments do not represent those of Reuters. For more information on our comment policy, see http://blogs.reuters.com/fulldisclosure/2010/09/27/toward-a-more-thoughtful-conversation-on-stories/ Comments (0) Be the first to comment on reuters.com. Add yours using the box above.

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