FDA Approves Non-Hormone Therapy for Hot Flashes! Safe Treatment That Works!

FDA Approves Non-Hormone Therapy for Hot Flashes!

Safe Treatment That Works!

An estimated 80% of women experience hot flashes or night sweats during the menopause transition, lasting up to ten years or more in many cases. Now there is help available for women who are not candidates, or do not wish to take, menopause hormone therapy (MHT) containing estrogen, the current gold standard treatment.

The FDA recently approved a game-changing, highly effective new non-hormone oral medication for treatment of menopause hot flashes and night sweats. The drug fezolinetant (name brand Veozah), is the first drug treatment for menopause-induced hot flashes to target a brain chemical called neurokinin B (NKB) that regulates body temperature. This is especially good news for women or men with a history or risk for estrogen-sensitive breast cancer who have limited options for treatment. 

Veozah is a selective estrogen receptor disruptor (SERD) that works by degrading estrogen receptors in the brain. Initial studies suggest Veozah is almost as effective as current menopause hormone therapy containing estrogen and progesterone. Until now, non-hormone therapy options included anti-anxiety or anti-depressant drugs prescribed off-label, but they may be less effective and sometimes cause undesirable side effects. Veozah appears to have an excellent safety profile, works quickly within a couple weeks of initiating treatment, and has limited side effects. Some women report headaches. Research participants reported a 57% reduction in hot flashes and improved sleep within a couple weeks of taking the daily medication. 

The FDA recommends providers conduct a blood test before prescribing Veozah and repeat it every three months for the first nine months due to rare occurrences of liver damage in earlier research studies where Veozah was prescribed at higher dosages. Liver damage has not been shown in current studies at the recommended lower dose of 45 mg per day. Veozah is considered safe during and after menopause until hot flashes have subsided. Prescribers are encouraged to recommend patients take a drug holiday every couple of years to see if their symptoms return. Veozah will be available in January 2024 at a pre-insurance cost of $550 for a 30-day supply, with patient price estimated to be lower after drug discounts and insurance coverage.