FDA Approves New Nonhormonal Menopause Medication to Treat Hot Flashes

Strategic Insights -

Lindsey Bever at The Washington Post reported that the Food and Drug Administration (FDA) has approved a new nonhormonal menopause medication to treat hot flashes. Elinzanetant, under the brand name Lynkuet, is a once-daily pill designed to target a key mechanism responsible for menopause-related hot flashes and night sweats. The medication, developed by Bayer, is expected to be available in the United States in November. With up to 80 percent of people experiencing hot flashes and night sweats during menopause, having limited effective treatment options outside hormone therapy is a significant issue.

Key Takeaways:

  • Elinzanetant, a nonhormonal menopause medication, has been approved by the FDA to treat hot flashes, targeting KNDy neurons in the hypothalamus, a region of the brain responsible for temperature regulation.
  • The medication, under the brand name Lynkuet, is a once-daily pill and is expected to be available in the United States in November.
  • In a clinical trial, elinzanetant reduced the frequency of daily moderate to severe hot flashes by more than 73 percent after 12 weeks compared to 47 percent on the placebo.
  • The medication also targets NK1 receptors, which are involved in sleep regulation, and may help with sleep and reduce the frequency and severity of hot flashes by dilating blood vessels.
  • The FDA is recommending liver function tests before starting Lynkuet and at the three-month mark due to the risk of liver problems, although clinical trials showed no cases of liver enzyme elevations meeting the criteria for liver injury.
  • Clinical trial participants reported headache, fatigue, and joint pain as side effects.
  • The wholesale cost of Lynkuet is $625 for a 30-day supply, with a copay savings card allowing some users to pay only $25 a month.
  • Several other nonhormonal treatments for menopause, including Brisdelle, Gabapentin, and off-label uses of selective serotonin reuptake inhibitors, have been mentioned in the article.

Statistics:

  • 80 percent of people experience hot flashes and night sweats during menopause.
  • 73 percent reduction in daily moderate to severe hot flashes was seen in clinical trials after 12 weeks of taking elinzanetant.
  • 47 percent reduction in daily moderate to severe hot flashes was reported by those on the placebo in clinical trials.
  • $625 is the wholesale cost of a 30-day supply of Lynkuet.
  • $25 is the estimated copay price after using a copay savings card.
  • 30-day supply duration for the medication.

Sources:

  • The Washington Post: Lindsey Bever
  • FDA Approval Document for Lynkuet (Elinzanetant)
  • Bayer Press Release: Lynkuet (Elinzanetant) Approval