The FDA on May 12 approved Astellas' Veozah — a once-a-day pill meant to treat hot flashes associated with menopause.
The drug is an alternative to hormone replacement therapies typically used to treat hot flashes, flushing and chills. However, hormone therapies are not an option for all women.
Fezolinetant, the drug's generic name, works by "binding to and blocking the activities of the [neurokinin 3 receptor], which plays a role in the brain's regulation of body temperature," the FDA said in a news release.
"Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life," Janet Maynard, MD, director of FDA's Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, said in the release. "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."
Abdominal pain, diarrhea, insomnia, back pain, flushing and elevated hepatic transaminases were the most common side effects reported in clinical trials. The drug will cost $550 a month, and Astellas is hoping for wide coverage from insurers, according to CNN.