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Drug approval

FDA Approves New Nonhormonal Menopause Medication to Treat Hot Flashes

Strategic Insights

— 2 min read

Lindsey Bever writes that the Food and Drug Administration has approved a new nonhormonal menopause medication, elinzanetant, to treat hot flashes. Elinzanetant, under the brand name Lynkuet, is a once-daily pill expected to be available in the United States in November. This medication belongs to a new class of drugs designed to target what is believed to be a key mechanism responsible for menopause-related hot flashes and night sweats.

Key Takeaways:

  • Elinzanetant, a nonhormonal medication, targets neurons in a part of the brain responsible for temperature regulation and appears to help reduce hot flashes by more than 73% after 12 weeks in clinical trials.
  • The medication is intended to target KNDy neurons in the hypothalamus, a region of the brain responsible for temperature regulation.
  • Elinzanetant also blocks NK1 receptors, which are involved in sleep regulation, and may help with sleep and may have an additional hot-flash benefit by playing a role in dilating the blood vessels, which helps to cool the body.
  • The FDA is recommending liver function tests before starting Lynkuet (elinzanetant) and at the three-month mark, due to the potential risk of rare cases of liver injury.
  • Clinical trial participants also reported headache, fatigue, and joint pain.
  • Bayer, the maker of Lynkuet, said the wholesale cost will be $625 for a 30-day supply, and patients may pay a portion depending on their insurance coverage.
  • The medication is expected to be covered by insurance, with a copay savings card that may allow patients to pay only $25 a month.
  • The only other nonhormonal medication approved by the FDA to treat symptoms of menopause is Brisdelle, which contains a lower dose of paroxetine than the antidepressant Paxil.
  • Having multiple medications that are effective for managing hot flashes is important because hot flashes have been linked to an increased risk of cardiovascular disease and dementia.

Statistics:

  • Up to 80 percent of people experience hot flashes and night sweats during menopause (Source: The facts).
  • Elinzanetant reduced the frequency of daily moderate to severe hot flashes by more than 73% after 12 weeks in clinical trials (Source: The fact - In a clinical trial, the drug reduced the frequency of daily moderate to severe hot flashes by more than 73 percent after 12 weeks. Those on the placebo reported a 47 percent reduction).
  • Clinical trials did not find any cases of liver enzyme elevations meeting the criteria for liver injury (Source: Is it toxic to the liver, and does it cause other side effects?).
  • The wholesale cost of Lynkuet (elinzanetant) will be $625 for a 30-day supply (Source: How much will it cost?).

Sources:

  • The Food and Drug Administration (FDA)
  • Bayer
  • The Menopause Society
  • The Center for Women's Health at Mayo Clinic
  • The University of Virginia
  • The Midlife Health division at the University of Virginia
  • UCLA Health's Comprehensive Menopause Program

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