FDA Approves First Non-Hormonal Drug for Menopause Hot Flashes
The Food and Drug Administration approved fezolinetant, a new non-hormonal medication, today to treat moderate to severe hot flashes and night sweats associated with menopause.
The drug, marketed as Lynkuet by Bayer, works by blocking neurokinin 3 (NK3) receptors in the brain, which are believed to play a key role in regulating body temperature. Clinical trials demonstrated significant reductions in the frequency and severity of vasomotor symptoms – the medical term for hot flashes and night sweats – without the risks associated with hormone therapy. This approval offers a new option for the millions of women experiencing menopause, many of whom seek alternatives to traditional hormone replacement.
Data presented to the FDA showed the therapy was well-tolerated, with the most common side effects being mild and including headache and upper respiratory tract infection. The approval is based on results from the Embrace 1 and Embrace 2 clinical trials. “This approval marks a significant step forward in providing women with additional treatment options for managing menopause symptoms,” stated an FDA representative. More information about managing menopause can be found at the National Women’s Health Information Center.
Lynkuet is expected to be available by prescription in the coming months. The FDA continues to review data on long-term effects and will monitor the drug’s performance in real-world settings, as detailed in our coverage of recent advances in women’s health.
Officials stated they will continue to evaluate new therapies for menopausal symptoms as they become available.
