Elinzanetant

The FDA accepted a new drug application for elinzanetant, a nonhormonal treatment for moderate to severe vasomotor symptoms associated with menopause, according to an industry press release.

CHICAGO — Nonhormonal elinzanetant was associated with fewer moderate to severe vasomotor symptoms compared with placebo for up to 1 year, along with similar long-term positive safety data, researchers reported.

Once-daily oral elinzanetant was well tolerated and improved moderate to severe vasomotor symptom frequency and severity, sleep disturbances and menopause-related quality of life, according to results of two studies published in JAMA.

SAN FRANCISCO — In two phase 3 trials, the nonhormonal investigational agent elinzanetant was associated with decreased frequency and severity of menopausal vasomotor symptoms over 12 weeks with a favorable safety profile.

Women reported a significantly lower frequency of moderate to severe menopausal vasomotor symptoms while taking elinzanetant vs. placebo, according to the results of a phase 3 trial.

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.