FDA Approves Novel Drug for the Treatment of Hot Flashes Caused by Menopause

_{©Argus/AdobeStock}

The US Food and Drug Administration (FDA) announced it has approved fezolinetant (Veozah^™, Astellas Pharma Inc.) 45 mg once daily for the treatment of moderate-to-severe vasomotor symptoms (VMS) due to menopause.

Fezolinetant is an oral medication, and it is the first neurokinin 3 (NK3) receptor antagonist approved by the FDA for treatment of moderate-to-severe VMS due to menopause, according to an FDA press release. This medication is not a hormone; fezolinetant binds and blocks activities of the NK3 receptor, which impacts the brain’s body temperature regulation, according to the agency.

“Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life,” said Janet Maynard, MD, MHS, director, Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, Center for Drug Evaluation and Research, FDA, in the May 12, 2023, press release. “The introduction of a new molecule to treat moderate to severe menopausal hot flashes will provide an additional safe and effective treatment option for women.”

Fezolinetant can be taken with or without food and should be taken at the same time each day. If a dose is missed or not taken at the regular time, patients should take it as soon as possible and return to their regular schedule the following day.

The FDA based its approval on results of two 12-week, randomized, placebo-controlled, double-blind phase 3 SKYLIGHT trials, in which women assigned fezolinetant experienced reduced VMS frequency and severity. Following the 12-week study period, women assigned placebo were re-randomized to fezolinetant for a 40-week extension study to demonstrate safety, according to the release.

The most common side effects of fezolinetant include abdominal pain, diarrhea, insomnia, back pain, hot flush, and elevated hepatic transaminases, according to the FDA.

“Today’s approval of fezolinetant is a significant and, I believe, long awaited milestone for individuals in the U.S. who experience moderate to severe vasomotor symptoms during the menopausal transition,” said Genevieve Neal-Perry, MD, PhD, Chair, University of North Carolina School of Medicine, Department of Obstetrics and Gynecology, in a May 13, 2023, Astellas press release. “This therapy is based on our understanding of the biology behind hot flashes. I’m excited to know that patients will have the option to choose this nonhormonal treatment.”