A panel of advisers to the Food and Drug Administration overwhelmingly voted against a Depomed drug to treat hot flashes and other symptoms of menopause.
The FDA panel voted 12-2 that the risks of the company's drug Sefelsa outweighed its benefits when used by menopausal women.
Depomed and other drugmakers have been experimenting with non-hormonal treatments for menopause, following studies showing that estrogen therapy could increase the risk of heart disease, stroke and breast cancer.
Known generically as gabapentin, Depomed's drug has long been used to treat pain and seizures. Doctors also prescribe the drug off-label, or without an FDA indication, to treat menopause symptoms. Newark, Calif.-based Depomed has asked the FDA to approve its version of the drug for that use, which would allow the company to explicitly market it directly to menopausal women.
However, panelists overwhelmingly recommended the FDA reject the use, pointing out that three company studies failed to show a significant reduction in hot flashes over 12 weeks. Patients also experienced side effects including dizziness, fatigue and balance problems. Gabapentin already carries a warning label that it can increase the frequency of suicidal thoughts.
Some panelists pointed out that the drug is already available off-label if doctors want to prescribe it, but that it didn't deserve full FDA approval given the weak results in company studies.
The FDA is scheduled to make a decision on whether to approve Depomed's application by May 31. The agency often follows the groups' advice, though it is not required to do so.
Trading in Depomed Inc. shares was halted ahead of the FDA meeting.