US EditionNew Menopause Drug to Target Hot Flashes without Hormones Gets FDA Approval
- The U.S. Food and Drug Administration approved once-daily oral Lynkuet for moderate to severe hot flashes due to menopause, Bayer said, calling it an important new option for women and providers.
- JoAnn V. Pinkerton, MD, UVA Health's director of midlife health, said hormone therapy is most effective but causes side effects and some women cannot use it due to contraindications to estrogen.
- The randomized OASIS 1, 2 and 3 double-blind, placebo-controlled Phase 3 trials showed postmenopausal women ages 40-65 receiving 120 mg elinzanetant daily reported significant reductions in vasomotor symptom frequency and severity, with improvements maintained over time, Bayer said.
- Pinkerton reported mild headache and fatigue as common adverse events, with no severe side effects in trials, reflecting the safety profile for trial participants and symptomatic menopausal women.
- Described as a novel therapy, Lynkuet is Bayer's first and only neurokinin-1 and neurokinin-3 receptor antagonist for menopause, highlighting its nonhormonal approach and Bayer's century-long women’s health research.
59 Articles
59 Articles
Night sweats and heat surges: New drug takes aim at menopause symptoms
Drugmaker Bayer announced that the Food and Drug Administration has approved a first-of-its-kind drug to treat moderate to severe hot flashes due to menopause.Lynkuet is a once-daily soft gel capsule that studies show can reduce the frequency and severity of hot flashes. The drug works by blocking both NK1 and NK3 receptors on KNDy neurons, calming the overactive temperature signals that trigger moderate to severe hot flashes.The drug has alread…
The U.S. Food and Drug Administration (FDA) approved another one-day hormone-free pill to treat moderate to severe hot flashes in menopausal women, reported this Friday...
New Medicine for Menopause to Treat Hot Flashes without Hormones Gets Fda Approval News Channel 3-12
By Jacqueline Howard, CNN The US Food and Drug Administration (FDA) has approved another once-a-day pill that works without hormones to treat moderate to severe hot flashes in menopausal women, drugmaker Bayer said Friday. The drug, elinzanetant, is expected to be available in the US starting in November under the brand name Lynkuet, according to Bayer. It works by blocking brain chemicals responsible for hot flashes and night sweats — what doct…
FDA approves nonhormonal drug to ease menopause hot flashes and night sweats
The federal Food and Drug Administration today approved a new menopause drug that reduces hot flashes and night sweats after the drug was successfully tested at UVA Health and other sites in the United States and around the world.
Coverage Details
Bias Distribution
- 89% of the sources are Center
Factuality
To view factuality data please Upgrade to Premium
