The phase 2 trial NIRVANA evaluating the safety and efficacy of elinzanetant in women with sleep disturbances associated with menopause (SDM) has been initiated, according to Bayer.
Takeaways
- Sleep disturbances associated with menopause (SDM) affect 40% to 60% of menopausal women and are a prevalent and disruptive symptom, impacting both work performance and quality of life.
- Bayer's new phase 2 trial, NIRVANA, aims to evaluate elinzanetant's safety and efficacy in treating SDM, a crucial area of unmet need in women's health.
- Elinzanetant is a non-hormonal dual neurokinin-1,3 (NK-1,3) receptor antagonist primarily developed for managing vasomotor symptoms (VMS) related to menopause. It modulates KNDy neurons that can become hypertrophic when estrogen levels drop.
- Beyond addressing VMS, elinzanetant may also help reduce SDM, potentially mitigating various adverse outcomes such as metabolic issues, cognitive decline, depressive symptoms, and cardiovascular health risks, which are not effectively managed by current treatments.
- The NIRVANA trial is a phase 2, randomized, double-blind study assessing elinzanetant's efficacy using polysomnography and patient-reported outcomes, aiming to offer a comprehensive understanding of its potential benefits in treating SDM.
Sleep disturbances are reported in approximately 40% to 60% of menopausal women, making them the most frequent and disruptive symptoms of menopause alongside vasomotor symptoms (VSM). SDM includes trouble falling asleep or staying asleep and are associated with decreased work performance and quality of life.
Bayer has stated 47 million new women enter menopause each year, with symptoms often adversely impacting quality of life, health care utilization, and work productivity. Addressing common symptoms such as SDM is vital to maintain functional ability.
Elinzanetant is a dual neurokinin-1,3 (NK-1,3) non-hormonal receptor antagonist developed to treat VMS associated with menopause. To manage VMS, elinzanetant modulates the KNDy neurons which become hypertrophic when estrogen levels decrease.
Elinzanetant may also be used to decrease SDM, potentially reducing risks of adverse outcomes such as negative effects on metabolism, body fat gain, cognitive health decline, depressive symptoms, and poor cardiovascular health later in life. Current treatments were not developed for the management of SDM.
NIRVANA is a phase 2, randomized, parallel-group treatment, double-blind study evaluating the safety and efficacy of elinzanetant for treating SDM. Efficacy was measured using polysomnography, a validated method to study sleep and sources behind sleep disturbances.
Patient-reported outcomes were also assessed to determine efficacy. Improvements were reported based on the Pittsburgh Sleep Quality Index and Insomnia Severity Index scores.
"This trial will allow us to look at elinzanetant’s unique dual MOA to get new insight into the specific cause of sleep disturbance in menopause and how to get patients needed relief. Inadequate sleep leads to fatigue, weight gain, and decreased productivity, so [it's] an important area to understand better and be able to improve for menopausal women," said JoAnn Pinkerton, MD, professor and director of Midlife Health at UVA Health.
"There are currently no medications for women that focus solely on menopausal issues like sleep beyond improvements in hot flashes. Normally, the discussion around menopause symptoms stays focused on VMS, or ‘hot flashes,’ when in fact these other symptoms of sleep disruption and decreased quality of life can be life-altering as well," Pinkerton added.
Reference
Bayer starts Phase II study NIRVANA to evaluate elinzanetant in women with sleep disturbances associated with menopause. Bayer. January 8, 2024. Accessed January 8, 2024. https://www.bayer.com/media/en-us/bayer-starts-phase-ii-study-nirvana-to-evaluate-elinzanetant-in-women-with-sleep-disturbances-associated-with-menopause/
