Brisdelle receives FDA approval to treat hot flashes associated with menopause

FDA approves the first non-hormonal treatment for hot flashes associated with menopause

The U.S. Food and Drug Administration today approved Brisdelle (paroxetine) to treat moderate to severe hot flashes (vasomotor symptoms) associated with menopause. Brisdelle, which contains the selective serotonin reuptake inhibitor paroxetine mesylate, is currently the only non-hormonal treatment for hot flashes approved by the FDA.

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

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

"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, M.D., M.M.Sc., director of the Division of Bone, Reproductive and Urologic Products in the FDA's Center for Drug Evaluation and Research. "Today's approval provides women with the first FDA-approved, non-hormonal therapeutic option to help ease the hot flashes that are so common in menopause."

The safety and effectiveness of Brisdelle 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 50-60 per week). The treatment period lasted 12 weeks in one study and 24 weeks in the other study. The results showed that Brisdelle reduced hot flashes compared to placebo. The mechanism by which Brisdelle reduces hot flashes is unknown.

The most common side effects in patients treated with Brisdelle 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 and Pexeva 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 (signs and symptoms can include confusion, rapid heart rate, and high blood pressure). Brisdelle will be dispensed with a Medication Guide that informs patients of the most important information about the medication. The Medication Guide will be distributed to patients each time the prescription is refilled.

Consumers and health care professionals are encouraged to report adverse reactions from the use of Brisdelle to the FDA MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 1-800-FDA-1088.

Brisdelle and Pexeva are marketed by Noven Therapeutics, LLC., based in Miami, Fla. Paxil is marketed by GlaxoSmithKline, based in Philadelphia, Pa.