FDA approves new nonhormonal medication for menopause hot flashes
Betsy Goodfellow | May 15, 2023 | News story | Medical Communications | FDA, HRT, Veozah, hot flashes, menopause
The US Food and Drug Administration (FDA) has announced its approval of Veozah (fezolinetant), an oral medication to treat moderate to severe vasomotor symptoms, or hot flashes, caused by menopause.
The drug is the first neurokinin 3 (NK3) receptor antagonist approved by the FDA to treat these symptoms, and works by binding to and blocking the activities of the NK3 receptor, which plays a role in the brain’s regulation of body temperature.
According to the FDA’s press release, “hot flashes occur in around 80% of menopausal women and can include periods of sweating, flushing and chills lasting for several minutes,” so new treatment options are likely to be gratefully received.
The efficacy of the drug was assessed in the 12-week, randomised, placebo-controlled, double-blind portions of two phase 3 clinical trials. The most common side effects of the drug included abdominal pain, diarrhea, insomnia, back pain, hot flashes and elevated hepatic transaminases.
Janet Maynard, MD MHS, director of the Office of Rare Diseases, Paediatrics, Urologic and Reproductive Medicine within the FDA’s Center for Drug Evaluation and Research, commented: “Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life. 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.”
Betsy Goodfellow
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