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Drug approval

FDA Approves New Nonhormonal Treatment for Menopause Symptoms

Strategic Insights

— 2 min read

The Food and Drug Administration has approved a new nonhormonal treatment for menopause symptoms, called Lynkuet, which contains the compound elinzanetant. This treatment has been shown to reduce hot flashes, night sweats, and sleep disturbances in menopausal women, offering a new option for those who cannot or do not want to take hormone therapy. Lynkuet works by blocking two types of receptors in the brain that affect temperature regulation and mood.

Key Takeaways:

  • Lynkuet, a nonhormonal treatment, has been approved by the FDA for the treatment of hot flashes and night sweats in menopausal women.
  • The treatment, which contains the compound elinzanetant, has been shown to reduce the frequency and severity of vasomotor symptoms, such as hot flashes and night sweats, in clinical trials.
  • Lynkuet was found to be effective in reducing hot flashes and night sweats in over 80% of patients at 26 weeks, with over 70% of patients experiencing at least a 50% drop in the frequency of hot flashes at 12 weeks.
  • The treatment also showed significant improvement in sleep disturbances, with more than 70% of patients reporting less sleep disturbance.
  • The most common side effects of Lynkuet were headache, fatigue, and joint pain, with a few patients experiencing elevated liver enzyme levels.
  • Elinzanetant would not be recommended for patients with known liver issues, and patients taking the treatment will be advised to have their liver function tested regularly.
  • Lynkuet is expected to be available by November, with a cost of $625 for a 30-day supply, although eligible patients with insurance may pay as little as $25.

Statistics:

  • Hot flashes and night sweats affect up to 80% of women during menopause.
  • Lynkuet was found to reduce hot flashes and night sweats in over 80% of patients at 26 weeks.
  • Over 70% of patients taking Lynkuet experienced at least a 50% drop in the frequency of hot flashes at 12 weeks.
  • More than 70% of patients taking Lynkuet reported less sleep disturbance.
  • The cost of Lynkuet is $625 for a 30-day supply, although eligible patients with insurance may pay as little as $25.

Sources:

  • (names and organizations exactly as mentioned in the source material)
  • The New York Times, "FDA Approves New Nonhormonal Treatment for Menopause Symptoms"
  • Dr. JoAnn Manson, an endocrinologist and professor at Harvard Medical School
  • Dr. JoAnn Pinkerton, a professor of obstetrics and gynecology at the University of Virginia Health System
  • Dr. Jewel Kling, a menopause expert and the chair of women’s health internal medicine at the Mayo Clinic in Arizona
  • Dr. Mary Jane Minkin, a clinical professor of obstetrics, gynecology and reproductive sciences at the Yale School of Medicine
  • Getty Images

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