The FDA has approved Bayer’s Lynkuet (elinzanetant), a novel once-daily non-hormonal medication for the treatment of moderate to severe hot flashes and night sweats in menopausal women. Lynkuet offers an alternative for patients who cannot or prefer not to use hormone therapy due to health risks or personal preference.
Lynkuet works by blocking neurokinin 1 and 3 (NK1/NK3) receptors on brain cells that regulate body temperature, interrupting the chemical signals that trigger vasomotor symptoms. Clinical studies, including the pivotal Phase 3 OASIS program, showed over a 73% reduction in the frequency of hot flashes within 12 weeks of treatment, compared to 47% for placebo. This effect was sustained for up to a year, with improvements also seen in sleep quality and overall menopause-related quality of life.
Hot flashes and night sweats affect nearly 80% of menopausal women, with symptoms sometimes lasting over a decade. Lynkuet’s approval expands the options for symptom management beyond traditional hormone therapy, which is contraindicated for some women with cancer or cardiovascular risks. Bayer expects Lynkuet to be available in the U.S. in November. Common side effects include mild drowsiness, fatigue, and headache.
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