Fezolinetant

The FDA added a boxed warning to highlight known risk for rare but serious liver injury associated with the use of fezolinetant, a nonhormonal medication indicated for treating menopausal hot flashes, according to an agency press release.

The FDA issued a warning that use of fezolinetant can cause rare but serious liver injury following a report of a patient with signs and symptoms of liver injury after taking the nonhormonal medication

The FDA issued a warning that use of fezolinetant, a nonhormonal medication indicated for treating menopausal hot flashes, can cause rare but serious liver injury, according to an agency press release.

Fezolinetant was associated with significant improvements in patient-reported vasomotor symptom frequency and menopause-specific quality of life, according to an analysis published in Menopause.

Fezolinetant and elinzanetant are both promising nonhormone therapies for managing vasomotor symptoms among postmenopausal women, with favorable safety profiles for up to 12 weeks, according to a systematic review published in Menopause.

Once-daily oral elinzanetant was associated with significantly reduced frequency of moderate to severe menopausal vasomotor symptoms compared with placebo, according to topline results from the OASIS 3 study.

Following positive topline data for moderate to severe vasomotor symptom treatment, a phase 2 study of elinzanetant is underway to assess its safety and efficacy on sleep disturbances associated with menopause, Bayer said in a news release.

Fezolinetant 45 mg once daily was statistically significantly more effective in reducing moderate to severe vasomotor symptom frequency compared with other nonhormonal — but not hormone-based — therapies in the U.S., researchers reported.

PHILADELPHIA — Nonhormone therapy options for vasomotor symptoms are important considerations for women who are not good candidates for or may not want to initiate hormone therapy, according to a speaker.

PHILADELPHIA — In this video exclusive, Nanette Santoro, MD, discussed efficacy for different groups of women of a nonhormonal neurokinin 3 receptor antagonist recently approved by the FDA to treat moderate to severe hot flashes.