Elinzanetant Demonstrates Sustained Efficacy Over One Year in Managing Menopausal Vasomotor Symptoms
Elinzanetant's Efficacy and Safety:
Elinzanetant, a non-hormonal dual neurokinin-1,3 (NK-1,3) receptor antagonist, has shown sustained efficacy and safety over one year in managing moderate to severe vasomotor symptoms (VMS) associated with menopause.
Clinical Trials:
The OASIS 1, 2, and 3 phase 3 studies have demonstrated significant reductions in VMS frequency, improvements in sleep disturbances, and enhancements in menopause-related quality of life. These studies included a large number of participants aged between 40 to 65 years.
Long-Term Safety:
The OASIS 3 study, which evaluated elinzanetant over 52 weeks, confirmed its long-term safety profile, consistent with previous studies and published data.
Impact on Sleep Disturbances:
Elinzanetant has also shown potential in treating sleep disturbances associated with menopause (SDM), a prevalent symptom affecting 40% to 60% of menopausal women. The NIRVANA trial is currently assessing its efficacy in this area.
Non-Hormonal Solution:
Elinzanetant offers a non-hormonal treatment option for menopausal symptoms, addressing a significant unmet need in women's health. Bayer plans to submit applications for marketing authorizations based on the positive results from the OASIS studies.