FDA Approves First Non-Hormonal Treatment for Menopausal Hot Flashes

The US Food and Drug Administration (FDA) has approved Noven Pharmaceuticals Inc.’s once-daily Brisdelle (paroxetine) capsules to reduce moderate to severe hot flashes and night sweats that can last up to five years in menopausal women.

Unlike previously approved medications for vasomotor symptoms (VMS) associated with menopause, Brisdelle doesn’t contain estrogen or estrogen with a progestin, making it the first and only non-hormonal VMS treatment approved for use in US women. Instead, the capsules contain 7.5 milligrams of paroxetine as a mesylate salt — a smaller dose of the selective serotonin reuptake inhibitor compared to medications currently approved for treating major depressive disorder, obsessive-compulsive disorder, and panic disorder, such as Noven’s existing Pexeva pharmaceutical.

Aside from the standard suicide warning that accompanies the active ingredient paroxetine, Brisdelle’s label also includes precautions about possible reduction in the efficacy of tamoxifen when administered with paroxetine, increased bleeding risk, and a risk of developing serotonin syndrome, whose signs and symptoms can comprise confusion, rapid heart rate, and high blood pressure. Among the 1,175 VMS patients enrolled in the drug’s two randomized phase 3 studies that established safety and effectiveness in reducing hot flashes compared to placebo, the most commonly reported adverse reactions to Brisdelle were headache, fatigue, and nausea and vomiting.

In a company press release, Joel Lippman, MD, FACOG, executive vice president of product development and chief medical officer at Noven, said 24 million women in the US experience moderate to severe VMS; however, Lippman noted that roughly two-thirds of those patients aren’t presently treating the bothersome symptoms because they’re unable or unwilling to take hormonal therapy for the condition. To make a non-hormonal treatment option available to all women with VMS, Noven President and CEO Jeffrey F. Eisenberg said he estimates Brisdelle will be offered at US pharmacies by November 2013.

“The FDA approval of Brisdelle addresses the unmet need for a clinically proven, non-hormonal treatment option for hot flashes and night sweats,” David Portman, MD, director of the Columbus Center for Women’s Health Research and a compensated consultant for Noven, said in the company’s press release. “As a clinician, the comprehensive prescribing information and proven data for Brisdelle enable me to confidently offer women with moderate to severe VMS a non-hormonal option that is safe and effective.”