The first non-hormonal treatment for menopause-associated hot flashes has been approved by the U.S. Food and Drug Administration.
The agency approved Brisdelle to treat moderate to severe hot flashes. The new drug contains paroxetine, a selective serotonin reuptake inhibitor (SSRI) antidepressant sold under the brand names Paxil and Pexeva. Brisdelle is taken once daily at bedtime.
There are a number of FDA-approved treatments for hot flashes, but all contain either estrogen alone or estrogen plus a progestin. Approval of Brisdelle was based on two clinical trials that included a total of 1,175 postmenopausal women and found that Brisdelle was more effective than a placebo at reducing hot flashes. Common side effects included headache, fatigue and nausea/vomiting.
Paxil and Pexeva carry a warning about an increased risk of suicide in children and young adults. Because Brisdelle contains the same active ingredient as those drugs, a warning about suicide risk is included on the new drug's label.
Menopause-associated hot flashes occur in up to 75 percent of women and can persist for five years or longer. While not life-threatening, hot flashes can cause discomfort, embarrassment and sleep disruption.
"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," Dr. Hylton Joffe, director of the Division of Bone, Reproductive and Urologic Products in the FDA's Center for Drug Evaluation and Research, said in an agency news release.
Brisdelle is marketed by Noven Therapeutics, LLC. of Miami, Fla.