Elinzanetant’s impact on vasomotor symptoms prompts study on menopausal sleep disturbances
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Key takeaways:
- Elinzanetant was associated with reduced frequency and severity of vasomotor symptoms in the OASIS studies.
- NIRVANA will assess elinzanetant for reducing sleep disturbances associated with menopause.
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.
Elinzanetant (Bayer) is an investigational dual neurokinin-1, 3 receptor antagonist. In the OASIS 1 and 2 phase 3 studies, elinzanetant demonstrated statistically significant reductions in both the frequency and severity of moderate to severe vasomotor symptoms related to menopause. Elinzanetant was also associated with reduced hot flash frequency from baseline to 1 week and improved sleep disturbances and menopause-related quality of life.
“Sleep is an incredible complex aspect of health and the human experience, and unfortunately, its importance is often underestimated and undervalued — for those experiencing menopause this is especially the case,” Hadine Joffe, MD, MSc, professor of psychiatry at Brigham and Women’s Hospital, Boston, said in the release.
NIRVANA, a phase 2, multicenter, double-blind, randomized, parallel group, placebo-controlled interventional study, will randomly assign 78 women from eight countries to assess the safety and efficacy of elinzanetant on sleep disturbances associated with menopause. The primary endpoint of NIRVANA is the impact of elinzanetant on wakefulness after sleep onset at 4 weeks measured by polysomnography.
“By adding NIRVANA to our broad clinical development program, we are further exploring the potential of elinzanetant to address sleep disturbances associated with menopause, an area of important unmet need in women’s health,” Christian Rommel, PhD, global head of research and development and member of the executive committee of Bayer AG’s pharmaceutical division, said in the release.