The Food and Drug Administration on Friday approved a new drug for the treatment of hot flashes and night sweats in menopausal women.
The drug, Lynkuet, which contains the compound elinzanetant, adds to a limited number of nonhormonal treatment options for these symptoms. Doctors said it might also be better than previous nonhormonal options at treating menopause-related sleep issues, though that comparison has yet to be directly studied.
The medication works by blocking two kinds of receptors in the brain that affect temperature regulation and may have effects on mood and sleep. Clinical trials showed that the drug significantly reduced the frequency and severity of vasomotor symptoms, meaning hot flashes and night sweats, compared with the placebo.
Hot flashes and night sweats affect up to 80 percent of women during menopause. These symptoms can be debilitating and long-lasting, with some women experiencing them for a decade or more. Studies have found that Black women, in particular, experience more severe and frequent hot flashes and for longer durations.
Hormone therapy — estrogen, often coupled with progesterone — is a safe and effective treatment for many women. But some women, including those who have or are at high risk for certain types of breast and ovarian cancer, cannot take it, and others aren’t comfortable with hormone therapy.
“To have nonhormonal options for them is tremendously important,” said Dr. JoAnn Manson, an endocrinologist and professor at Harvard Medical School.
Elinzanetant belongs to a similar class of drugs as fezolinetant, which the F.D.A. approved under the brand name Veozah in 2023. Before fezolinetant, the only approved nonhormonal drug for menopause-related hot flashes was the antidepressant paroxetine, though some doctors prescribe other medications off label.
Elinzanetant is the first drug approved by the F.D.A. for hot flashes that works on two different kinds of receptors in the brain; fezolinetant blocks only one of those two. Both receptors are involved in temperature regulation; the additional one targeted by elinzanetant may also independently regulate sleep. That could mean that elinzanetant is more effective at treating sleep disturbances in addition to vasomotor symptoms, but no trial has directly compared the two drugs.
The trials studying elinzanetant looked at postmenopausal women age 40 to 65 who had persistent and bothersome hot flashes, said Dr. JoAnn Pinkerton, a professor of obstetrics and gynecology at the University of Virginia Health System and one of the trial investigators. In two separate, double-blinded trials, symptom improvement began one week after starting the treatment. More than 70 percent of people receiving the drug reported at least a 50 percent drop in the frequency of hot flashes at 12 weeks, compared with more than 40 percent of patients receiving the placebo.
Patients taking elinzanetant also experienced significantly less sleep disturbance.
The effects persisted over time — and those in the placebo group who switched to taking the drug at 12 weeks benefited roughly equally, Dr. Pinkerton said. At 26 weeks, more than 80 percent of patients receiving the drug reported at least a 50 percent drop in the frequency of hot flashes.
Side effects included headache, fatigue and joint pain. A few patients showed elevated liver enzyme levels, but Dr. Pinkerton said there were no concerning signs of liver toxicity.
Elinzanetant would not be recommended for patients with known liver issues. Liver toxicity is a rare side effect of fezolinetant, and patients taking that drug are advised to have their liver function tested every few months; patients taking elinzanetant will also be advised to receive tests.
Dr. Jewel Kling, a menopause expert and the chair of women’s health internal medicine at the Mayo Clinic in Arizona, said she had been pleased to see no clear sign of liver toxicity in the trials of elinzanetant, though rare side effects can sometimes fail to show up in clinical trials.
Many menopausal women have trouble falling or staying asleep. Often, this is a consequence of hot flashes and night sweats, but menopause may also affect sleep directly. The dual action of elinzanetant might help with those issues in a way fezolinetant doesn’t, said Dr. Mary Jane Minkin, a clinical professor of obstetrics, gynecology and reproductive sciences at the Yale School of Medicine who specializes in menopause.
Bayer, the manufacturer of Lynkuet, said it expected the drug to be available by November. The cost for a 30-day supply is $625, but eligible patients with insurance could pay as little as $25, the company said.
Dr. Minkin said elinzanetant would not be a full substitute for hormone therapy. Estrogen can treat not only hot flashes and sleep disturbances but also a wide range of menopausal symptoms across the body, including body aches, vaginal dryness and more; it also helps protect against osteoporosis.
But Dr. Minkin and other experts agreed that it was significant to have a new nonhormonal option.
“Having more tools in our tool kit to improve women’s quality of life is a good thing,” Dr. Kling said.
Nina Agrawal is a Times health reporter.
Maggie Astor covers the intersection of health and politics for The Times.
The post F.D.A. Approves New Menopause Drug appeared first on New York Times.
