FDA approves new menopause drug to treat hot flashes

The US Food and Drug Administration has approved a new type of drug to treat hot flashes and night sweats associated with menopause.

Veozah, an oral medication for the treatment of moderate to severe severe vasomotor symptoms caused by menopause, is the first neurokinin 3 (NK3) receptor antagonist approved by the FDA to treat moderate to severe hot flashes from menopause.

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 occur in around 80 per cent of menopausal women and can include periods of sweating, flushing and chills lasting for several minutes.

Some women who experience hot flashes and have a history of vaginal bleeding, stroke, heart attack, blood clots or liver disease, cannot take hormone therapies.

“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 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.”

Veozah targets the neural activity which causes hot flashes during menopause. However, it 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 of Veozah reported in the studies included abdominal pain, diarrhea, insomnia, back pain, hot flush and elevated hepatic transaminases.