FDA Approves New Hormone-Free Menopause Drug to Treat Hot Flashes
The U.S. Food and Drug Administration (FDA) has approved a new hormone-free medication named Lynkuet, developed by Bayer. This once-daily pill addresses moderate to severe hot flashes in menopausal women. It is expected to be available in the United States starting in November 2023.
About Lynkuet and Its Mechanism
Lynkuet, scientifically known as elinzanetant, targets the brain’s neurotransmitters responsible for hot flashes and night sweats, collectively termed vasomotor symptoms (VMS). Hot flashes affect more than 80% of women during menopause, making effective treatment essential.
Clinical Trial Results
A Phase 3 clinical trial included 628 postmenopausal women. Participants who took elinzanetant for 12 weeks experienced a 73% decrease in the frequency of VMS. In comparison, those on a placebo showed only a 47% reduction.
Expert Insights
Christine Roth, Bayer’s executive vice president, emphasized the significance of this approval. “This FDA approval represents a bold step forward – our first hormone-free treatment for alleviating vasomotor symptoms of menopause,” she stated. Roth highlighted the need for personalized menopause care, indicating that Lynkuet fills a crucial gap in available treatments.
Dr. JoAnn Pinkerton from UVA Health, involved in the study, noted that the findings confirmed rapid and sustained relief from hot flashes and night sweats. “The disruptive nature of these symptoms can significantly affect women’s daily lives,” she mentioned, advocating for more non-hormonal treatment options.
Understanding Hot Flashes
Hot flashes involve a sudden sense of warmth, typically affecting the face, chest, and head, accompanied by intense sweating. Night sweats, occurring during sleep, can lead to further discomfort. The frequency of these episodes can range from occasional occurrences to several times a day, severely disrupting daily activities.
Treatment Options Beyond Hormones
For women unable or unwilling to use hormone therapy, alternative treatments are vital. Claire Gill, founder of the National Menopause Foundation, reaffirmed the importance of providing women with diverse treatment options. The approval of Lynkuet marks an expansion in the range of available therapies.
Significance of Lynkuet’s Approval
This new medication joins fezolinetant, another FDA-approved menopause drug from 2023, also designed to manage hot flashes without hormones. Both drugs exploit a newly identified neurokinin pathway that regulates hot flashes, marking a breakthrough in menopausal care.
- Medication: Lynkuet (elinzanetant)
- Approval Date: November 2023
- Target Symptoms: Moderate to severe hot flashes
- Clinical Trial: 73% reduction in symptoms after 12 weeks
- Common Side Effects: Drowsiness, fatigue, headaches
With the approval of Lynkuet, healthcare providers have a new first-line option for treating moderate to severe hot flashes due to menopause, improving the quality of life for many women.
