Daily Dose: FDA Approves Fezolinetant for Treatment of Hot Flashes Caused by Menopause

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On May 15, 2023, we reported on the US Food and Drug Administration (FDA) approval of fezolinetant (Veozah™, Astellas Pharma Inc.) 45 mg once daily for the treatment of moderate-to-severe vasomotor symptoms (VMS) due to menopause.

The approval

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

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.

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

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