The Food and Drug Administration Friday approved the first nonhormonal drug designed to treat hot flashes, one of the most bothersome symptoms of menopause.
The drug, which will be sold with the brand name Brisdelle, is a low-dose form of the antidepressant paroxentine, commonly known as Paxil. It will be marketed by Noven Pharmaceuticals Inc., a U.S. unit of Hisamitsu Pharmaceutical Co.
The decision is a surprise after an FDA advisory panel voted in March, 10 to 4 against the drug's benefit-risk profile. The same panel split in a 7 to 7 vote on whether clinical data submitted in support of the drug showed it was effective at reducing hot flashes. The FDA, however, isn't bound by advisory panel decisions.
"There are a significant number of women who suffer from hot flashes associated with menopause and who cannot or do not want to use hormonal treatments," said Hylton V. Joffe, the director of FDA's bone, reproductive and urologic products division.
Other approved FDA products for hot flashes contain estrogen alone or estrogen plus a progestin. FDA has advised doctors to prescribe those products at the lowest dose for the shortest possible amount of time.