Astellas Announces Positive Phase 3 Long-Term Safety Results for Fezolinetant in Menopausal Vasomotor Symptoms

On March 7, 2022, Astellas announced topline results from a Phase 3 long-term safety clinical trial of fezolinant, an investigational oral non-hormonal compound. The trial aimed to evaluate the long-term safety of the drug in treating moderate to severe vasomotor symptoms (VMS) associated with menopause, to support future regulatory submissions. VMS, characterized by hot flashes and/or night sweats, are common symptoms experienced by women during menopause.

Menopausal women experience a decline in estrogen levels in the bloodstream as the ovaries stop producing estrogen, leading to VMS, commonly characterized by hot flashes and night sweats. Statistics show that nearly 80% of women will experience VMS, with most reporting moderate or severe symptoms, and these symptoms can persist for years. Fezolinetant is an investigational selective neurokinin-3 (NK3) receptor antagonist. The press release notes that if approved, fezolinetant would become the "first-in-class" non-hormonal treatment option to reduce the frequency and severity of VMS associated with menopause.

This randomized, double-blind, placebo-controlled Phase 3 clinical trial was conducted in more than 1,800 women seeking treatment for menopause-related VMS, lasting 52 weeks. The trial met its primary endpoint assessing endometrial health. The most common treatment-emergent adverse events (TEAEs) in the treatment group were headache and COVID-19, consistent with the placebo group. The main data obtained further demonstrated the long-term safety profile of fezolinant, with detailed results to be submitted for publication in the future.

(Note: The original text has been abridged)

References:

[1] Astellas Announces Topline Results from Long-Term Phase 3 Safety Study of Fezolinetant which Inform Future Regulatory Filings for the Treatment of Vasomotor Symptoms Associated with Menopause. Retrieved March 7, 2022, from https://www.astellas.com/en/news/25321

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