Hormone-free drug for hot flashes succeeds in phase 3 trials

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MedlinePlus defines menopause as the time in a woman's life when her period stops.

Fezolinetant first ‘highly effective drug without significant side effects’

Hot flashes — that prize you get for surviving menstrual cramps for three or four decades — might soon be a thing of the past, thanks to a new drug.

During its phase 3 SKYLIGHT-2 trial, fezolinetant, an investigational, nonhormonal treatment, reduced the number of hot flashes caused by menopause.

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Genevieve Neal-Perry, MD, PhD, of the University of North Carolina at Chapel Hill, presented her findings at ENDO 2022, the Endocrine Society’s annual meeting in Atlanta.

In her study of 484 women with moderate to severe hot flashes — or vasomotor symptoms — taking fezolinetant once a day “significantly improved frequency and severity of VMS versus placebo.”

Study participants were given either a 30mg or 45mg dose of fezolinetant, with both doses cutting down how often VMS occurred in the first 12 weeks. When a 40-week extension was tacked on, VMS frequency continued to decrease.

In addition to fewer hot flashes, the researchers said fezolinetant was linked to improved sleep.

“It is a novel, nonhormonal treatment that women who either cannot take hormones or who have, for some reason, selected not to do so,” Neal-Perry said at a press conference. “They now have an opportunity to have treatment for their bothersome symptoms.”

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She continued: “There hasn’t been a lot of focus ... on hot flashes. It’s something that women are just expected to live through.

“(Fezolinetant) is a boon because we haven’t had other treatment options that are highly effective without significant side effects,” she concluded.

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