FDA green lights a new type of drug for menopausal hot flashes

The US Food and Drug Administration on Friday approved a new type of drug to treat hot flashes and night sweats during menopause.

Veozah, or fezolinetant, made by Astellas Pharma, is the first neurokinin 3 (NK3) agonist. It blocks receptors in the brain that play a role in the regulation of body temperature. It’s an alternative to traditional hormone replacement therapies to manage hot flashes, which are a common symptom of menopause that can be disruptive if they become severe.

Women at higher risk of stroke, heart attacks, or some kinds of cancer are sometimes advised against using hormone replacement therapies because they increase the risk of blood clots and cancers.

“Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life,” said Dr. Janet Maynard, director of the FDA’s Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the Center for Drug Evaluation and Research, in a news 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.”

Menopause is a normal period in a woman’s life that usually begins in her mid- to late 40s. During menopause, the body produces less estrogen and progesterone. The tapering of these hormones can trigger sleep disruptions, mood swings and hot flashes – periods of sweating, flushing and chills that may last several minutes.

In clinical trials that included more than 3,000 women in the US and Canada, Veozah reduced the number of hot flashes women experienced each week significantly more than a placebo. The studies followed women who took the drug for a year.

Veozah comes with a warning about a risk of liver injuries. The FDA says women who are considering taking it should have blood tests to make sure they don’t have any liver damage or infection before starting the medication, and they should be monitored with blood tests every three months to make sure they don’t show signs of liver damage while taking the drug.

The most common side effects reported in the studies were abdominal pain, diarrhea, insomnia, back pain, hot flush and elevated liver enzymes.


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