July 10, 2013
Nonhormonal Hot Flash Treatment Will Be Available
Later This Year

Washington, D.C.—Menopausal women who suffer moderate-to-severe hot flashes now have a novel treatment option, the first nonhormonal compound approved by the FDA for that purpose.

Brisdelle (paroxetine), developed by Noven Pharmaceuticals of Miami and New York, contains the selective serotonin reuptake inhibitor (SSRI) paroxetine mesylate. It is expected to be available in pharmacies by November.

Approval came despite a 10 to 4 vote by the FDA’s Reproductive Health Drugs Advisory Committee that the overall risk/benefit profile of low-dose mesylate salt of paroxetine was not acceptable to support approval.

The other FDA-approved treatments for hot flashes contain either estrogen alone or estrogen plus a progestin.

“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, MD, MMSc, director of the FDA’s Division of Bone, Reproductive and Urologic Products. “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.”

Two randomized, double-blind, placebo-controlled studies involving 1,175 postmenopausal women with moderate to severe hot flashes—defined as a minimum of seven to eight per day or 50 to 60 per week—established the safety and effectiveness of Brisdelle, according to the FDA.

The studies, with a 12-week treatment period in one study and a 24-week treatment period in the other study, showed that Brisdelle reduced hot flashes compared to placebo, although the FDA noted that the mechanism by which Brisdelle does that is not known.

Headache, fatigue, and nausea/vomiting were the most common side effects reported for Brisdelle, which contains 7.5 mg of paroxetine and is dosed once daily at bedtime.

Because Brisdelle contains the same active ingredient as Paxil and Pexeva, a Boxed Warning about increased suicidality in children and young adults is included in its label. The FDA pointed out, however, that 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.

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, which can cause confusion, rapid heart rate, and high blood pressure.

A Medication Guide informing patients of the most important information about the medication will be required to be dispensed with Brisdelle each time a prescription is filled or refilled.

U.S. Pharmacist Social Connect