NIRVANA Phase II Trial: Bayer Tests ElinzaNetant for Menopausal Sleep Issues

Bayer, a prominent entity in women's healthcare, has announced a new Phase II study named NIRVANA, designed to investigate the efficacy and safety of an experimental compound called elinzanetant. This compound is being considered as a non-hormonal treatment for sleep disturbances that are associated with menopause. Such disturbances can significantly affect a woman's quality of life, work productivity, and overall physical and mental health.

Menopause is a phase that can lead to various symptoms, with sleep disturbances being among the most common and disruptive. Studies suggest that a considerable percentage of women experience these disturbances during the menopausal transition, which can lead to a range of negative outcomes, including metabolic issues, weight gain, cardiovascular problems, cognitive decline, and depression. The current treatments available do not specifically target these sleep disturbances.

Dr. Christian Rommel, a key member of Bayer AG’s Pharmaceutical Division, has emphasized the importance of addressing this unmet need in women's health. The NIRVANA study is a significant step in this direction, aiming to explore the potential of elinzanetant in managing these sleep issues. The study will be a multi-center, double-blind, randomized, parallel-group, placebo-controlled interventional study, with approximately 78 participants across eight countries.

The primary goal of the NIRVANA study is to assess the efficacy of elinzanetant on reducing Wakefulness After Sleep Onset (WASO), as measured by polysomnography, a method used to study sleep and the underlying causes of sleep disturbances. The study will also evaluate the safety profile of elinzanetant for the treatment of sleep disturbances associated with menopause.

In addition to the NIRVANA study, Bayer has also reported positive topline results from the pivotal Phase III studies OASIS 1 and 2. These studies evaluated elinzanetant's efficacy and safety in treating moderate to severe vasomotor symptoms (VMS) associated with menopause. Elinzanetant demonstrated statistically significant reductions in the frequency and severity of VMS compared to placebo, as well as improvements in sleep disturbances and menopause-related quality of life.

Elinzanetant is a novel dual neurokinin-1,3 (NK-1,3) receptor antagonist that is in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS. It works by modulating estrogen-sensitive neurons in the hypothalamus, which are believed to contribute to the thermoregulatory disruptions that cause VMS. The compound may also help decrease sleep disturbances associated with menopause.

Menopause affects a growing global population, with projections indicating that by 2030, 1.2 billion women worldwide will be experiencing this phase. The symptoms of menopause can have a substantial impact on a woman's health, quality of life, and work productivity. Addressing these symptoms is crucial for maintaining functional ability and quality of life, which is of significant importance from both healthcare and socio-economic perspectives.

Bayer has a long-standing commitment to women's healthcare, offering a range of treatments and focusing on innovative options to meet the unmet medical needs of women globally. The company also aims to provide access to family planning for 100 million women per year in low-and-middle income countries by 2030, in line with the United Nations' Sustainable Development Goals.

Bayer is a global enterprise with a focus on life sciences, striving to support people and the planet by addressing major challenges presented by a growing and aging global population. The company is dedicated to driving sustainable development and generating a positive impact through innovation and growth.