WASHINGTON — The U.S. Food and Drug Administration approved Veozah (fezolinetant), an oral medication for the treatment of moderate to severe hot flashes, caused by menopause.
Veozah is the first neurokinin 3 (NK3) receptor antagonist approved by the FDA to treat moderate to severe hot flashes from menopause and it works by binding to and blocking the activities of the NK3 receptor, which plays a role in the brain’s regulation of body temperature.
“Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life,” said Janet Maynard, M.D., M.H.S., 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.”
Menopause, often referred to as “the change of life,” is a normal, natural change in a woman’s life when her period stops, usually occurring between ages 45 and 55. During menopause, a woman’s body slowly produces less of the hormones estrogen and progesterone. Hot flashes occur in around 80% of menopausal women and can include periods of sweating, flushing and chills lasting for several minutes.
Patients taking Veozah should take one 45-milligram pill orally, once a day, with or without food. The pill should be taken at the same time each day. If a dose is missed, or not taken at the regular time, patients should take it as soon as possible and return to their regular schedule the following day.
The effectiveness of Veozah to treat moderate to severe hot flashes was demonstrated in each of the first 12-week, randomized, placebo-controlled, double-blind portions of two phase 3 clinical trials. In both trials, after the first 12 weeks, the women on placebo were then re-randomized to Veozah for a 40-week extension study to evaluate safety. Each trial ran a total of 52 weeks. The average age of the trial participants was 54 years old.
The most common side effects of Veozah include abdominal pain, diarrhea, insomnia, back pain, hot flush and elevated hepatic transaminases.
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