FDA approves first nonhormonal treatment for hot flashes associated with menopause

FDA has approved low-dose paroxetine capsules (Brisdelle, Noven Pharmaceuticals), 7.5 mg/day, for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause, also referred to as hot flashes and night sweats.

Prior to the approval of Brisdelle, hormone therapy was the only FDA-approved treatment for VMS. 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.

“The approval of Brisdelle provides an alternative treatment for hot flashes, which can affect a large percentage of women who experience menopause,”said Abimbola Farinde, PharmD, MS, clinical staff pharmacists at Clear Lake Regional Medical Center, Webster, Texas. “The controlled-release form of  Paxil already has an FDA-approved indication for premenstrual dysphoric disorder, so it is not surprising that it has garnered the indication for hot flashes associated with menopause as well. For some women who are opposed to taken estrogen or estrogen- and progestin- containing hormone replacement therapies, paroxetine may help to alleviate the discomfort that can be associated with hot flashes.”

Brisdelle’s safety and effectiveness were established in 2 randomized, double-blind, placebo-controlled studies in a total of 1,175 postmenopausal women with moderate to severe hot flashes (a minimum of 7 to 8 per day or 50 to 60 per week). The treatment period lasted 12 weeks in 1 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. Headache, fatigue, and nausea/vomiting were the most common side effects in patients treated with Brisdelle. Nausea occurred primarily within the first 4 weeks of treatment and fatigue occurred primarily within the first week of treatment, and decreased in frequency with continued therapy.

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

Brisdelle will be available in U.S. pharmacies in November 2013.