The US Food and Drug Administration (FDA) approved a new oral drug last Friday for the treatment of moderate to severe vasomotor symptoms, or hot flashes, due to menopause. The drug is called Wozah (phaseolinent), and according to the agency, it works by blocking the activities of a receptor in the brain that plays a role in regulating body temperature.
“Hot flashes as a result of menopause can be a serious physical burden for women and can affect their quality of life,” said Janet Maynard, director of the Office of Rare Diseases, Pediatrics, Urological and Reproductive Medicine, in the FDA report. He adds: “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 known to be a normal and natural change in a woman’s life that usually occurs between the ages of 45 and 55. During menopause, a woman’s body gradually produces fewer hormones. Hot flashes occur in about 80% of menopausal women and may include periods of sweating, hot flashes, and chills lasting several minutes. However, some of these women cannot take hormonal therapy because they have a history of blood clots, liver disease, or stroke. But Wozah is not a hormone.
Patients taking Wozah should take one 45 mg tablet by mouth once a day with or without food. The tablet should be taken at the same time every day. If a dose is missed or not taken at the usual time, patients should take it as soon as possible and return to their regular schedule the next day. Its effectiveness in treating hot flashes was shown in the first 12 weeks of the two clinical trials where the drug was tested.
The most common side effects of Wozah include abdominal pain, diarrhea, insomnia, back pain, hot flashes, and elevated liver transaminases. Astellas Pharma US, Inc. is a pharmaceutical company manufacturing the drug. The company announced that the drug would cost $550 dollars (only 2.5 million Colombian pesos) for a 30-day supply. The company said it would launch an assistance program “to help patients access the medicines they’ve been prescribed”.
