2023-05-15 15:55:05
The Food and Drug Administration (FDA), the regulatory agency of the United States equivalent to Anvisa, approved on Friday (12/5) the use of a non-hormonal drug intended for the treatment of moderate to severe hot flashes caused by menopause.
Treatment is an option for women who cannot take hormone therapies because of a history of vaginal bleeding, stroke, heart attack, blood clots or liver disease.
Veozah, made by Japanese drugmaker Astellas Pharma, is a neurokinin 3 (NK3) receptor antagonist. It works by blocking the activities of the NK3 receptor, which plays a role in regulating body temperature in the brain.
During menopause, a woman’s body produces less estrogen and progesterone hormones. It is estimated that 8 out of 10 suffer from hot flashes at this stage. They may include periods of sweating, redness of the skin, and chills that last for several minutes.
“Hot flashes as a result of menopause can be a serious physical burden for women and affect their quality of life,” Janet Maynard, director of the FDA’s Office of Rare Diseases, Pediatrics, Urological and Reproductive Medicine, said in a statement. .
clinical study
A phase 3 clinical study, the most advanced, showed that the daily use of the drug, always at the same time, helped to reduce the frequency and severity of the volunteers’ vasomotor symptoms and improved their quality of life while undergoing treatment. The results contributed to the authorization of the North American regulatory agency.
The most common side effects were abdominal pain, diarrhea, insomnia, back pain and elevated liver enzymes. There is, however, a warning regarding the risk of liver damage. The FDA says women considering taking it should have blood tests to ensure they don’t have any liver damage or infection before starting the drug, and they need to be monitored with blood tests every three months.
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