Advisors to the FDA recommended Monday that the agency reject a drug made by Depomed, Inc., which reduces the frequency and severity of hot flashes associated with menopause.
The advisory panel voted 13-1 that Depomed failed to prove convincingly that the drug worked – and that the drug’s risks outweighed its benefits.
Clinical trials of Depomed's drug found that it only partially reduced hot flashes and had numerous side effects, including dizziness, sleepiness, headache and nausea.
Meanwhile, the FDA does not have to follow the recommendations of its advisory panels but it usually does.
Depomed's drug was approved in the United States in 2011 to treat shingles-related pain and is marketed under the brand Gralise. Shares of the drug were halted pending the panel's vote at $6.52 on Nasdaq.
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