FDAapproves fezolinetant, an oral medication for the treatment of moderate to severe hotflashes in menopausal women. menopause womenshealth
In the two-phase trial, women were randomly assigned to receive either 30 mg or 45 mg of fezolinetant or placebo. After 12 weeks, women in placebo groups were re-randomized to fezolinetant for a 40-week safety study.
The study population included women aged 40-65 years, with an average minimum of seven moderate-to-severe hot flashes per day. The study included 120 sites in North America and Europe. At 12 weeks, both placebo and fezolinetant patients experienced reductions in moderate to severe vasomotor symptoms of approximately 60%, as well as a significant decrease in vasomotor symptom severity.
The FDA statement noted that patients should undergo baseline blood work before starting fezolinetant to test for liver infection or damage, and the prescribing information includes a warning for liver injury; blood work should be repeated at 3, 6, and 9 months after starting the medication, according to the FDA and the manufacturer
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