fda alert

FDA Approves Novel Treatment for Menopausal Hot Flashes

Leigh Precopio

The FDA has approved fezolinetant as the first neurokinin 3 receptor antagonist approved for the treatment of moderate to severe vasomotor symptoms caused by menopause. 

Vasomotor symptoms, often called hot flashes, occur in approximately 80% of individuals experiencing menopause. Many women who experience vasomotor symptoms have a history of bleeding, stroke, or other comorbidities that prevent them for taking hormone therapies to manage these symptoms. Fezolinetant works by binding to and blocking the activities of the neurokinin 3 receptor, which targets the neural activity causing vasomotor symptoms without the need for hormones.

The approval was based on the first 12-weeks of two randomized, double-blind phase 3 trials, which first examined the effectiveness of fezolinetant. After 12 weeks, individuals initially assigned to placebo were then re-randomized to receive treatment for a 40-week extension study to examine the safety of fezolinetant. Both trials ran for a total of 52 weeks.

Individuals are to take one daily dose of fezolinetant 45 mg orally, with or without food. Patients should take their medication at the same time each day. In the case of missed doses, patients should take the dose as soon as possible and return to their regular dose schedule the following day.

Common adverse effects include abdominal pain, diarrhea, insomnia, back pain, host flush, and elevated hepatic transaminases. Fezolinetant includes a warning for elevated hepatic transaminase, and all patients should undergo blood work before beginning fezolinetant. Individuals taking fezolinetant should undergo blood work every 3 months for the first 9 months on the medication. Fezolinetant cannot be used with CYp1A2 inhibitors. Patients with prior cirrhosis, severe renal damage, or end-stage renal disease should not take fezolinetant.

“Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life,” said the director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDA’s Center for Drug Evaluation and Research, Janet Maynard, MD, MHS. “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.”



FDA approves novel drug to treat moderate to severe hot flashes caused by menopause. News release. US Food and Drug Administration; May 12, 2023. Accessed June 5, 2023.