Brisdelle wins FDA approval for treatment of hot flashes

The FDA today approved paroxetine to treat moderate to severe hot flashes associated with menopause, according to a press release.

The agency’s decision makes paroxetine (Brisdelle, Noven Therapeutics), which is a selective serotonin reuptake inhibitor, the only non-hormonal treatment for hot flashes, the release stated.

Researchers assessed the safety and efficacy of paroxetine in two randomized, double blind, placebo-controlled studies that included a total of 1,175 postmenopausal women with a minimum of seven to eight hot flashes per day or 50 to 60 per week. Duration of treatment was 12 weeks in one study and 24 weeks in the other. Results indicated that paroxetine reduced hot flashes, as compared with placebo. The most common side effects reported in patients treated with paroxetine were headache, fatigue and nausea or vomiting.

The mechanism by which paroxetine reduces hot flashes remains unknown.

The drug contains 7.5 mg of paroxetine and is dosed once daily at bedtime. Other medications, including Paxil (GlaxoSmithKline) and Pexeva (Noven), contain higher doses of paroxetine, according to the release, and are approved for treating conditions such as major depressive disorder, obsessive-compulsive disorder, panic disorder and generalized anxiety disorder. These medications have a boxed warning about an increased risk for suicide in children and young adults. Consequently, because Brisdelle also contains the same active ingredient, a boxed warning about suicidality is also included in the Brisdelle label.

The label also includes warnings about a possible reduction in the efficacy of tamoxifen when both medications are used together; an increased risk for bleeding; and a risk for developing serotonin syndrome.

Paroxetine will be dispensed with a medication guide informing patients of the most important information about the medication, according to the release.