Could This Finally Be a Cure for Hot Flashes? FDA Approves Groundbreaking New Drug

Veozah, an oral medication to treat hot flashes, is an alternative to hormone replacement therapies or for those who have been treated for hormone-sensitive cancers


The U.S. Food and Drug Administration has approved the first nonhormonal medication to treat severe hot flashes in menopausal women.

On Friday, the agency announced the approval of oral medication fezolinetant — marketed as Veozah — which targets the neural activity in the brain that plays a role in regulating body temperature. Veozah, made by Astellas Pharma, is an alternative treatment to hormone replacement therapies or for people who have been treated for hormone-sensitive cancers.

Astellas Pharma said the new medication could be available in pharmacies within weeks and will cost $550 per month before insurance. However, the company is expecting wide coverage from insurance companies.

Menopause is the time that marks the end of a woman's reproductive years, or twelve months without a menstrual period. It usually occurs when women are in their 40s and 50s, but the average age is 51 in the U.S. Symptoms include irregular periods, hot flashes, mood swings, sleep problems, vaginal and bladder problems, loss of bone density and higher cholesterol levels — some of which come on gradually.

Hot flashes are the sudden feeling of warmth in the upper body, which is usually most intense over the face, neck and chest, according to the Mayo Clinic. This can cause sweating, rapid heartbeat, feelings of anxiety, a flushed appearance with red, blotchy skin, and a chilled sensation following the heat.

In a clinical trial of more than 3,000 women with an average age of 54, patients who took Veozah experienced a reduced number of hot flashes each week, significantly less than those who took a placebo, according to the FDA.

Related: Menopause Symptoms Cost Working Women in the U.S. $1.8 Billion Each Year, New Study Finds

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"Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life," Dr. Janet Maynard, official with the FDA's Center for Drug Evaluation and Research, said in a press 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."

Veozah is to be taken once daily, with or without food. Common side effects include abdominal pain, diarrhea, insomnia, back pain, hot flush and elevated hepatic transaminases, the agency says.

"Today's approval of fezolinetant is a significant and, I believe, long awaited milestone for individuals in the U.S. who experience moderate to severe vasomotor symptoms during the menopausal transition," Dr. Genevieve Neal-Perry, chair of Obstetrics and Gynecology at the UNC School of Medicine, said in a statement. "This therapy is based on our understanding of the biology behind hot flashes. I'm excited to know that patients will have the option to choose this nonhormonal treatment."

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