(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)
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