The Food and Drug Administration has approved a new medication, Lynkuet, to treat hot flashes, night sweats, and sleep disturbances in menopausal women — expanding treatment options beyond traditional hormone therapy.
The drug, developed by Bayer and containing the compound elinzanetant, is among the few nonhormonal therapies available for menopause-related symptoms. Clinical trials showed that elinzanetant significantly reduced both the frequency and intensity of vasomotor symptoms — the hot flashes and night sweats experienced by as many as 80% of women during menopause. Many participants also reported improved sleep quality.
Elinzanetant works by blocking two types of brain receptors involved in regulating body temperature, mood, and sleep. That dual mechanism distinguishes it from fezolinetant, another nonhormonal treatment approved in 2023 under the brand name Veozah, which affects only one of those receptors. Researchers believe this additional target may help alleviate sleep problems often associated with menopause.
In double-blind clinical trials involving women aged 40 to 65, results appeared within a week of treatment. After 12 weeks, more than 70% of participants taking the drug experienced at least a 50% reduction in hot flashes compared with about 40% of those on a placebo. At 26 weeks, the improvement persisted, with more than 80% reporting continued relief.
Side effects were generally mild and included headache, fatigue, and joint pain. Some participants experienced temporary increases in liver enzymes, though there were no serious cases of liver toxicity. Still, the FDA recommends periodic liver function tests for patients taking the drug, as is advised with other medications in the same class.
Lynkuet is not recommended for individuals with existing liver conditions, and experts emphasized that it is not a substitute for estrogen-based therapies, which can address a broader range of menopause-related symptoms, such as vaginal dryness and bone loss. However, for women who cannot or prefer not to use hormones — including those with a history of breast or ovarian cancer — the new drug offers a promising alternative.
Bayer said Lynkuet will be available in pharmacies by November. A 30-day supply will cost $625, though patients with insurance may pay as little as $25.
Source: NYT