Women who suffer from hot flashes caused by menopause will be able to get some relief now that the U.S. Food and Drug Administration (FDA) has approved an oral medication designed to treat moderate to severe symptoms.
Veozah became the first neurokinin 3 receptor antagonist approved by the FDA. It blocks NK3 receptor activity, which regulates body temperature, according to an FDA press release.
"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, the 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."
Patients prescribed Veozah are advised to take one 45mg pill by mouth once a day, either with or without food, at the same time each day, the press release days. Patients should aim to take them at the same scheduled time every day, but if a dose is missed it should be taken as soon as possible.
Veozah's effectiveness in treating hot flashes was studied in two phase 3 clinical trials, each consisting of a 12-week randomized, placebo-controlled, double-blind portion. After the initial 12 weeks, participants on placebo were then switched to Veozah for a 40-week extension study to evaluate safety. The trials lasted a total of 52 weeks, with an average participant age of 54 years, the release stated.
The press release said women could experience side effects taking Veozah. The most common side effects included abdominal pain, diarrhea, insomnia, back pain, hot flush, and elevated hepatic transaminases. Also, Veozah carries a warning for potential liver injury. Before starting Veozah, patients are advised to undergo liver function tests and have regular blood work done every three months for the first nine months of treatment.
The bad news: the price, as with many new medications. "Veozah will be available in pharmacies within the next three weeks, and the cost of the pill will be $550 for a one-month supply, according to the company," a report in Everyday Health says. "They also plan to offer a financial support program to make the medication more affordable."
