Depomed Fails to Win U.S. Approval for Menopause Drug

Depomed Inc. failed to win U.S. approval for a drug to ease hot flashes associated with menopause that regulatory advisers had said was too risky to clear for sale.

The Food and Drug Administration can’t approve the application in its present form, the Newark, California-based company said in a statement today. Depomed, which already sells gabapentin as a treatment called Gralise for pain associated with shingles, reiterated that it won’t further invest in plans to expand the drug to be used for menopausal hot flashes.

The drug would have been a non-hormonal alternative to existing medicines found to increase the risk of heart attack, breast cancer and stroke. However, advisers to the FDA voted March 4 that the risks of gabapentin outweighed the benefits. The panel reached the same conclusion about another treatment to ease hot flashes from Hisamitsu Pharmaceutical Co.

Depomed said then it would stop spending on the drug’s development as a hot flash treatment.

Clinical trials struggled to show gabapentin had an effect up to 12 and 24 weeks out, FDA staff said in a February staff report. The treatment also carries a risk of suicidal thoughts as indicated on the labels of other drugs with the same active ingredient including Gralise and anti-seizure medications.

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