Lynkuet (elinzanetant), a new nonhormonal drug made by Bayer, is now available for treating moderate to severe hot flashes and night sweats caused by menopause.
Hot flashes and night sweats affect up to 80% of women during menopause and can last seven to 10 years. These symptoms can also lead to sleep problems and mood changes that affect quality of life.
How Well Does Lynkuet Work to Reduce Hot Flashes?
Lynkuet is the first FDA-approved menopause drug that targets and blocks two brain receptors, neurokinin 1 (NK1) and neurokinin 3 (NK3). Blocking these receptors helps stabilize the body’s internal thermostat, reducing the frequency and severity of hot flashes and night sweats.
A similar nonhormonal drug, Veozah (fezolinetant), approved in 2023, blocks only the NK3 receptor. Targeting the additional receptor may help improve sleep, said JoAnn Pinkerton, MD, a professor of obstetrics and gynecology at the University of Virginia School of Medicine and an investigator for Lynkuet’s clinical trials.
Trial results showed that Lynkuet improved hot flashes within a week in postmenopausal women ages 40 to 65. At 12 weeks, more than 70% of participants reported at least a 50% drop in the frequency of their hot flashes.
Who Would Benefit From Using Lynkuet?
New options for managing menopause symptoms are important. Since the 1940s, hormone replacement therapy (HRT) has been the main treatment for menopause.
The 2002 Women’s Health Initiative study initially found that HRT increased the risk of blood clots, breast cancer, and stroke. Later reviews showed that HRT is generally safe for women who begin treatment around the time of menopause, but many remain hesitant.
“Some women can’t take HRT because of health risks, but others remain concerned even though the clinical trial has been reevaluated,” Pinkerton said.
Lynkuet is intended for patients who can’t use HRT or prefer to avoid it, said Amy Voedisch, MD, a clinical associate professor of obstetrics and gynecology at Stanford Medicine who was not involved with the clinical trials for Lynkuet.
Voedisch said people who are considering Lynkuet can ask their doctor the following questions:
- Do you think this is an appropriate medication for me to consider?
- What benefits should I expect to gain from the medication?
- How soon should I expect to see results?
- Are there any other benefits that I can expect aside from fewer hot flashes? (Improvements in sleep were found in the clinical trials with both Veozah and Lynkuet, with even more benefit noted with Lynkuet.)
Lynkuet doesn’t help with other menopause symptoms, such as vaginal dryness.
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What Are the Side Effects of Lynkuet?
Common side effects of Lynkuet include headache, fatigue, dizziness, drowsiness, abdominal pain, rash, diarrhea, and muscle spasms. People taking the drug are also advised against eating grapefruit or drinking grapefruit juice to avoid drug interaction.
Because Veozah, a similar drug, has been linked to rare cases of liver problems, the FDA is requiring Lynkuet users to have liver function tests before starting treatment and again after three months of use. If the results are normal, no additional testing is needed.
How Much Will Lynkuet Cost?
Lynkuet is expected to cost $650 per month out-of-pocket, though Bayer may offer a savings program.
Pinkerton said that insurers are also likely to require women who want to take the drug to try two marginally effective but less expensive drugs, Gabapentin and Effexor, before authorizing Lynkuet.
