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FDA Approves New Non-Hormonal Treatment for Menopause Symptoms
**Washington D.C. ** – The U.S.
Food and Drug Administration (FDA) has given the green light to a new non-hormonal medication, elinzanetant (Lynkuet), offering a fresh option for women grappling with disruptive menopause symptoms like hot flashes and night sweats. This once-daily pill is anticipated to hit pharmacies in the coming weeks.
Menopause-related discomforts affect a significant portion of women-up to 80%-and can persist for a decade or longer, severely impacting daily life and sleep quality, according to The Menopause Society. For those unable to safely undergo hormone therapy or who prefer not to, this new treatment provides a crucial alternative.
“To have non-hormonal options for them is tremendously important,” stated Dr. JoAnn Manson, an endocrinologist and professor at Harvard Medical School.
Elinzanetant is a pioneering drug that operates by targeting and blocking two distinct receptors in the brain, both integral to the body’s temperature regulation system. By interfering with these receptors, the medication aims to stabilize a woman’s internal thermostat, thereby diminishing the frequency and intensity of hot flashes and night sweats.
Bayer, the manufacturer, has announced that Lynkuet will be available to women in November. The drug joins fezolinetant (Veozah), another non-hormonal option that targets a single receptor. Experts suggest that elinzanetant’s action on an additional receptor may also aid in regulating sleep, potentially addressing sleep disturbances common during menopause.
Dr. JoAnn Pinkerton, a trial investigator and professor at the University of Virginia Health System, noted that participants in clinical trials experienced significantly improved sleep in addition to a reduction in hot flashes. These trials, which focused on postmenopausal women aged 40 to 65 experiencing persistent hot flashes, revealed promising results:
- Symptom improvement was observed as early as one week into treatment.
- After 12 weeks, over 70% of women reported at least a 50% decrease in hot flash frequency. This improvement continued, with more than 80% reporting the same reduction at 26 weeks.
Common side effects reported included headache, fatigue, and joint pain. However, due to a small number of patients exhibiting elevated liver enzyme levels, Lynkuet will not be recommended for individuals with pre-existing liver conditions. Patients taking elinzanetant will also be advised to undergo regular liver function tests, similar to the recommendations for fezolinetant.
Dr. Jewel Kling, a menopause expert at the Mayo Clinic, expressed relief at “no clear sign of liver toxicity in the trials of elinzanetant.” She did, however, caution that rare side effects sometimes only become apparent once a drug is widely available for public use.