Hot Flash Drugs Fail to Win FDA Advisers’ Support
Two drugs now on the market for other indications failed to win the backing of U.S. regulatory advisers for use in easing hot flashes associated with menopause as alternatives to hormonal therapy.
The benefits of medicines from Depomed Inc. (DEPO) and Hisamitsu Pharmaceutical Co. (4530)’s Noven unit in helping women avoid sudden sweating and feverish feelings linked to menopause didn’t outweigh side effects such as suicidal thoughts, advisers to the Food and Drug Administration voted today.
Depomed already sells gabapentin, voted down 12-2, as a treatment for postherpetic neuralgia, a complication of shingles. Hisamitsu’s paroxetine mesylate, voted down 10-4, is sold in the U.S. for depression, panic disorder and other conditions.
Hot flashes affect about 32 million women in the U.S. and 40 percent choose to not use hormones or aren’t good candidates for them, according to Newark, California-based Depomed. The company today said it will stop all spending on the drug’s development as a non-hormonal treatment for hot flashes after the FDA advisers’ decision. The shares sank.
“We recognize and appreciate the concerns that were raised by the members of the Advisory Committee,” Depomed Chief Executive Officer Jim Schoeneck said in a company statement today. “Based on today’s meeting we believe the hurdles for approval of a non-hormonal treatment for hot flashes remain high.”
The FDA isn’t required to follow the panel’s recommendations. It is scheduled to decide on Depomed’s drug by May 31 and Saga, Japan-based Hisamitsu’s product by June 28.
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