New Hormone-Free Pill Approved for Menopausal Hot Flashes
The US Food and Drug Administration has approved a new once-a-day pill, elinzanetant, which provides a hormone-free treatment for moderate to severe hot flashes in menopausal women, drugmaker Bayer announced. The medication is expected to become available in the United States in November under the brand name Lynkuet, reports BritPanorama.
Elinzanetant functions by blocking the brain chemicals that trigger hot flashes and night sweats, known as vasomotor symptoms. More than 80% of women experience hot flashes during menopause, indicating a widespread need for effective treatments.
A Phase 3 clinical trial involving 628 postmenopausal women demonstrated significant results. Those taking elinzanetant for 12 weeks reported a more than 73% reduction in the frequency of vasomotor symptoms, compared to a 47% reduction reported by those on a placebo. The most common side effects included drowsiness, fatigue, and headaches.
Christine Roth, Bayer’s executive vice president of global product strategy and commercialization, commented on the approval, stating, “This FDA approval represents a bold step forward – our first hormone-free treatment for alleviating vasomotor symptoms of menopause.” Roth emphasized the importance of personalized approaches in menopause care, noting that Lynkuet addresses a significant gap in treatment options.
For many women, conventional hormone therapy is a viable treatment for menopause symptoms, such as hot flashes. However, there are instances where women with specific health concerns may be advised against it. Experts suggest that alternatives like elinzanetant can play a crucial role for those who cannot or choose not to undergo hormone replacement therapies.
Researcher Dr. JoAnn Pinkerton from UVA Health noted, “This yearlong study not only confirmed the initial findings of rapid and significant reduction in the frequency and severity of hot flashes and night sweats but also provided evidence that these effects were sustained over a year, offering hope for longer-term relief.” Pinkerton highlighted the persistent nature of hot flashes and their negative impact on women’s lives, reinforcing the need for effective non-hormonal treatments.
As estrogen levels decrease during menopause, the hypothalamus becomes more active, resulting in an overproduction of neurokinins that trigger hot flashes. Both elinzanetant and the previously approved fezolinetant utilize a new understanding of this mechanism to provide relief by blocking neurokinin activity.
In 2023, the FDA approved fezolinetant, marking a shift in menopause treatment and expanding options beyond traditional hormone therapies. This progress reflects a broader understanding of menopause and the need for diverse treatment solutions to cater to women’s varying health profiles and preferences.
