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FDA Panel Rejects Depomed Menopause Treatment

From Associated Press (March 4, 2013)

WASHINGTON -- Shares of Depomed slid Friday after a panel of advisers to the Food and Drug Administration overwhelmingly voted against its 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.

The company believes it will be difficult to get a drug for hot flashes approved, said Depomed CEO Jim Schoeneck in a press release. Depomed will stop all spending related to the experimental treatment "until we believe there is a positive direction for Sefelsa."

Depomed and other drug makers 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 had 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 advice from advisory panels, though it is not required to do so.

Depomed shares fell 64 cents, or 9.8 percent, to close at $5.89.


Posted: March 2013