Oral Medication to Treat ‘Hot Flashes’ Could Be Available Soon
By Jonathan Springston, Editor, Relias Media
The FDA has approved the first neurokinin 3 (NK3) receptor antagonist to alleviate symptoms associated with moderate to severe vasomotor symptoms (“hot flashes”) caused by menopause.
Veozah (fezolinetant), a once-daily oral medication (45 mg), binds to and blocks NK3 receptors, which play a role in body temperature regulation. Hot flashes occur for many menopausal women (generally, age 45 to 55 years), leading to periods of sweating, flushing, and chills that last for a few minutes.
“Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life,” said 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. “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.”
Astellas, the drug’s manufacturer, tested the safety and efficacy of Veozah through its Bright Sky program, three Phase III clinical trials that included more than 3,000 participants in Canada, Europe, and the United States. The FDA granted priority review based on data from each of the first 12-week, randomized, placebo-controlled, double-blind portions of two of these Phase III trials.