FDA Approves New Hormone-Free Pill to Treat Hot Flashes in Menopausal Women

The US Food and Drug Administration has approved a new once-a-day pill called elinzanetant, which works without hormones to treat moderate to severe hot flashes in menopausal women. Manufactured by Bayer, the pill will be available in the United States starting in November under the brand name Lynkuet. Elinzanetant is estimated to be a game-changer for over 80% of women who experience hot flashes during menopause. The pill blocks the brain chemicals responsible for hot flashes and night sweats, providing a much-needed alternative to hormone replacement therapies for women with underlying health conditions or histories.

Key Takeaways:

• The FDA has approved elinzanetant, a hormone-free pill to treat moderate to severe hot flashes in menopausal women, which will be available under the brand name Lynkuet.
• Over 80% of women experience hot flashes during menopause, and this new pill offers a hormone-free alternative to traditional hormone replacement therapies.
• A Phase 3 clinical trial of elinzanetant involving 628 postmenopausal women found that those taking the drug experienced a more than 73% reduction in vasomotor symptoms (VMS) after 12 weeks.
• The most common side effects of elinzanetant were drowsiness, fatigue, and headaches.
• The treatment options for women with moderate to severe menopausal symptoms have been limited, and this approval expands the options for women who cannot or choose not to undergo hormone therapy.
• Elinzanetant works by blocking the brain chemicals responsible for hot flashes, providing a new pathway in the brain that controls hot flashes.
• This approval provides healthcare providers with a new treatment option that can be used first-line for moderate to severe hot flashes due to menopause.
• Researcher Dr. JoAnn Pinkerton noted that this 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.

Statistics:

• Over 80% of women experience hot flashes during menopause.
• A Phase 3 clinical trial of elinzanetant involving 628 postmenopausal women found that those taking the drug experienced a more than 73% reduction in vasomotor symptoms (VMS) after 12 weeks.
• The placebo group experienced a 47% reduction in VMS.
• The most common side effects of elinzanetant were drowsiness, fatigue, and headaches.

Sources:

• Bayer
• Dr. JoAnn Pinkerton, UVA Health's director of midlife health and emeritus executive director of the North American Menopause Society
• Claire Gill, president and founder of the National Menopause Foundation
• CNN