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The FDA has approved paroxetine (Brisdelle), a selective serotonin reuptake inhibitor (SSRI), to treat moderate to severe hot flashes associated with menopause.
"Today's approval provides women with the first FDA-approved, nonhormonal therapeutic option to help ease the hot flashes that are so common in menopause," said Hylton Joffe, MD, director of the division of bone, reproductive, and urologic products at the FDA's Center for Drug Evaluation and Research.
The safety and efficacy of the drug in this condition was established in two randomized, double-blind, controlled studies in 1,175 postmenopausal women with moderate to severe hot flashes.
Women in the study had a minimum of seven to eight hot flashes per day or 50 to 60 per week.
Treatment lasted 12 weeks in one study and 24 weeks in another, and both trials showed that paroxetine reduced hot flashes better than placebo.
The most common side effects with the drug included headache, fatigue, and nausea or vomiting,
The dosage approved for use in hot flashes (7.5 mg) is far lower than that used in conditions such as major depressive disorder, obsessive-compulsive disorder, panic disorder, and generalized anxiety disorder.
Still, the medication will contain a boxed warning about suicidality given that this side effect is included in the label for the drug when it is used in higher doses in the other conditions.
Additional warnings that will be included in the label will note a possible reduction in the efficacy of tamoxifen if both medications are used together, an increased risk of bleeding, and a risk of developing serotonin syndrome – symptoms of which include confusion, rapid heart rate, and high blood pressure.
The drug will be marketed by Noven Therapeutics of Miami.