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FDA Approves First Non-Hormonal Therapy for Hot Flashes Associated With Menopause

Brisdelle contains low-dose paroxetine (June 28)

The FDA has approved Brisdelle (paroxetine, Noven Therapeutics) to treat moderate-to-severe hot flashes (vasomotor symptoms) associated with menopause. Brisdelle, which contains the selective serotonin reuptake inhibitor (SSRI) paroxetine mesylate, is currently the only non-hormonal treatment for hot flashes approved by the agency.

Several FDA-approved treatments are available for hot flashes, but all contain either estrogen alone or estrogen plus a progestin.

Hot flashes associated with menopause occur in up to 75% of women and can persist for up to 5 years, or even longer in some women. Hot flashes are not life-threatening, but the symptoms can be bothersome, causing discomfort, embarrassment, and disruption of sleep.

The safety and effectiveness of Brisdelle (paroxetine) were established in two randomized, double-blind, placebo-controlled studies in a total of 1,175 postmenopausal women with moderate-to-severe hot flashes (a minimum of seven to eight per day or 50 to 60 per week). Treatment lasted 12 weeks in one study and 24 weeks in the other study. The results showed that paroxetine reduced hot flashes compared with placebo. The mechanism by which paroxetine reduces hot flashes is unknown.

The most common side effects observed in patients treated with paroxetine were headache, fatigue, and nausea/vomiting.

Brisdelle contains 7.5 mg of paroxetine and is dosed once daily at bedtime. Other medications, such as Paxil (GlaxoSmithKline) and Pexeva (Noven Therapeutics), contain higher doses of paroxetine and are approved for treating conditions such as major depressive disorder, obsessive-compulsive disorder, panic disorder, and generalized anxiety disorder.

All medications that are approved for treating depression, including Paxil and Pexeva, have a boxed warning about an increased risk of suicide in children and young adults. Because Brisdelle contains the same active ingredient as Paxil and Pexeva, a boxed warning about suicidality is included in the Brisdelle label.

Additional labeled warnings include a possible reduction in the effectiveness of tamoxifen if both medications are used together, an increased risk of bleeding, and a risk of developing serotonin syndrome (characterized by confusion, rapid heart rate, and high blood pressure).

Source: FDA; June 28, 2013.

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