The United States Food and Drug Administration recently approved the first non-hormonal solution to hot flashes associated with menopause; it is the drug Brisdelle. Nearly 75% of menopausal women experience hot flashes, which are extreme feelings of warmth accompanied with redness and sweating. While hot flashes can spread over the entire body, they are mostly concentrated in the face and neck. Hot flashes are the most common side effect of menopause, and while the exact cause of hot flashes is unknown, a great deal of research is conducted on alleviating this discomfort for women. This new drug Brisdelle offers a non-hormonal alternative to the hormone therapy options currently available.
Brisdelle contains paroxetine mesylate, a serotonin reuptake inhibitor, which differs from other FDA-approved hot flash treatments that contain the hormones estrogen and progestin. Brisdelle underwent two randomized, double-blind, placebo-controlled studies with 1,175 postmenopausal participants and was found to produce positive results compared to the placebo control. The drug is taken once a day and some side effects include nausea, vomiting, fatigue, and headache. The director of the Division of Bone, Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research, Hylton V. Joffe, M.D., M.M.Sc., expressed that Brisdelle is a breakthrough product for women “who cannot or do not want to use hormonal treatments” for hot flashes associated with menopause. Brisdelle can now be added to the many treatment options available to women who experience symptoms related to menopause.
To read more about Brisdelle, click here.