Two phase 3 trials showed that elinzanetant reduced VMS frequency and improved VMS severity at weeks 4 and 12
By Elana Gotkine HealthDay Reporter
TUESDAY, Aug. 27, 2024 (HealthDay News) — For menopausal vasomotor symptoms (VMS), elinzanetant is efficacious and well-tolerated, according to a study published online Aug. 22 in the Journal of the American Medical Association.
JoAnn V. Pinkerton, M.D., from the University of Virginia Health in Charlottesville, and colleagues examined the efficacy and safety of elinzanetant, a selective neurokinin-1,3 receptor antagonist, for the treatment of moderate-to-severe menopausal VMS in two randomized, double-blind, phase 3 trials (OASIS 1 and 2), including postmenopausal participants aged 40 to 65 years. Eligible participants were randomly assigned to elinzanetant 120 mg for 26 weeks (199 and 200 in OASIS 1 and 2, respectively) or matching placebo for 12 weeks followed by elinzanetant 120 mg for 14 weeks (197 and 200 in OASIS 1 and 2, respectively).
The researchers found a significant reduction in VMS frequency with elinzanetant at week 4 (â3.3 and â3.0 in OASIS 1 and 2, respectively) and week 12 (â3.2 and â3.2 in OASIS 1 and 2, respectively). In addition, the severity of VMS was improved with elinzanetant at week 4 (â0.3 and â0.2 in OASIS 1 and 2, respectively) and week 12 (â0.4 and â0.3 in OASIS 1 and 2, respectively). Improvement in sleep disturbances and menopause-related quality of life was seen with elinzanetant at week 12, and the safety profile was favorable.
“Elinzanetant has the potential to provide a well-tolerated and efficacious nonhormonal treatment option to address the unmet health needs of many menopausal individuals with moderate-to-severe VMS,” the authors write.
Several authors disclosed ties to pharmaceutical companies, including Bayer, which manufactures elinzanetant and funded the OASIS 1 and 2 trials.
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