Bayer is expanding the clinical development program for the investigational compound elinzanetant, being developed as a non-hormonal treatment for sleep disturbances associated with menopause. 

The first study participants were recently enrolled in NIRVANA, an exploratory phase 2 study to evaluate the efficacy and safety of elinzanetant, a dual neurokinin 1 and 3 receptor antagonist. 

Together with vasomotor symptoms (also known as hot flashes) and mood symptoms, sleep disturbances belong to the most frequent and disruptive symptoms associated with menopause. Approximately 40% to 60% of women experience sleep disturbances during the menopausal transition, which may include trouble falling asleep or staying asleep, potentially causing a negative impact on women’s quality of life and limiting their daily activities, including performance at work. 

Sleep disturbances associated with menopause may also be associated with negative effects on metabolism, body fat gain, poor cardiovascular health in later life, cognitive health decline, and depressive symptoms. Current treatments do not specifically target sleep disturbances associated with menopause.

“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,” says Christian Rommel, PhD, member of the executive committee of Bayer AG’s pharmaceutical division and global head of research and development, in a release. 

The NIRVANA phase 2 trial is a multi-center, double-blind, randomized, parallel-group, placebo-controlled interventional study. It is intended to randomize approximately 78 participants in eight countries. The primary endpoint for the NIRVANA study is the efficacy of elinzanetant on wakefulness after sleep onset at week four as measured by polysomnography.

“Sleep is an incredibly 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,” says Hadine Joffe, MD, MSc, professor of psychiatry in the field of women’s health based at Brigham and Women’s Hospital and psychiatrist and sleep researcher in women’s mental health, in a release.

Additionally, Bayer announced the results of the pivotal phase 3 studies OASIS 1 and 2 evaluating the efficacy and safety of elinzanetant. Elinzanetant met all four primary endpoints in both studies, demonstrating statistically significant reductions in the frequency and severity of moderate to severe vasomotor symptoms from baseline to week four and 12 compared to placebo. 

Both studies also achieved all three key secondary endpoints, showing a statistically significant reduction in the frequency of vasomotor symptoms from baseline to week 1, as well as statistically significant improvements in sleep disturbances and menopause-related quality of life compared to placebo, according to the company. The safety profile observed in the OASIS 1 and 2 studies is overall consistent with previously published data on elinzanetant.

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