First Non-Hormonal Menopause Medication Approved by FDA

The United States Food and Drug Administration recently approved a non-hormonal medication, Brisdelle, to treat the symptoms of hot flashes and night sweats for women going through menopause, according to a press release by the FDA. The drug, which was developed by the drug manufacturer Noven Pharmaceuticals and is currently the only FDA-approved non-hormonal medication for menopause, will be available at U.S. pharmacies this November.

Brisdelle contains a low dose of paroxetine, a drug traditionally used to treat depression, obsessive-compulsive disorder, panic disorder and other conditions. According to Noven, the drug was clinically tested on 1,276 women experiencing hot flashes and night sweats stemming from menopause. Menopause occurs when a woman’s period stops, usually after she has reached the age of 45, according to MedLinePlus. Menopause is characterized by a change in period flow, hot flashes or night sweats, difficulty sleeping and other changes. The changes from menopause can occur many years before the period fully stops.

Extreme symptoms of menopause were traditionally treated through hormonal therapy that replaced hormones the female body stops making, such as estrogen and progesterone. Hormonal therapy decreased in popularity after 2002 “when a large clinical trial showed the therapy increased the risk of heart disease and breast cancer,” according to the Reuters.

Reuters reports that an advisory committee for the FDA originally voted against Brisdelle’s approval, explaining that the drug did not show “enough benefits to offset the risks.” Along these lines, the FDA notes that the drug will come with “a Boxed Warning about suicidality.” The FDA further notes that the Boxed Warning was included because the drug contains the same active ingredient as some depression medications, and all approved depression medications include a Boxed Warning concerning suicide. Other side effects reported for Brisdelle include headache, fatigue, nausea and/or vomiting.

Noven has been developing the drug since 2007. It originally took over the manufacturing of the drug from another pharmaceutical company when the drug was in the infancy of its development. Noven Pharmeceuticals is based in Miami.