FDA approves fezolinetant to treat hot flashes caused by menopause

Key takeaways :

• The FDA approved oral fezolinetant for moderate to severe hot flashes due to menopause.
• Approval was based on results of the SKYLIGHT trials, which demonstrated safety and efficacy of fezolinetant.

The FDA announced it has approved fezolinetant for the treatment of moderate to severe hot flashes due to menopause.

Fezolinetant (Veozah, Astellas Pharma) is an oral medication. It is the first neurokinin 3 receptor antagonist approved by the FDA for treatment of moderate to severe vasomotor symptoms, according to an FDA press release. This medication is not a hormone; fezolinetant binds and blocks activities of the neurokinin 3 receptor, which impacts the brain’s body temperature regulation, according to the release.

Treatment is one 45 mg pill once daily, with or without food.

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

FDA approval was based upon results of two 12-week, randomized, placebo-controlled, double-blind phase 3 SKYLIGHT trials, in which women assigned fezolinetant experienced reduced vasomotor symptom 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 release.