FDA approves non-hormonal pill for menopausal hot flashes

The U.S. Food and Drug Administration (FDA) has approved a new non-hormonal pill to treat moderate to severe hot flashes, a common symptom of menopause.
“Having safe and effective non-hormonal options for the treatment of bothersome hot flashes is extremely important,” says JoAnn E. Manson, MD, MPH, DrPH, professor at Harvard Medical School and chief of preventive medicine at Brigham and Women’s Hospital in Boston.
“Many women are not candidates for hormone therapy due to a history of estrogen-sensitive cancer or other medical issues, and some would simply prefer to avoid taking hormones,” says Dr. Manson. “The growing arsenal and toolbox of non-hormonal treatment options for people experiencing moderate to severe hot flashes is good news for women. »
Lynkuet reduced daily hot flashes by 55% in trials
Although the study was not designed to assess sleep problems, researchers also found that Lynkuet was associated with fewer sleep problems and better quality of life.
Common side effects included headache and fatigue, according to the JAMA study.
How Lynkuet Works for Hot Flashes
In the years before menopause, the ovaries gradually slow down production of the hormones estrogen and progesterone, a process that eventually ends menstrual cycles. It can also cause symptoms ranging from vaginal dryness and mood swings to joint pain, memory problems and insomnia.
Hot flashes and night sweats (called vasomotor symptoms) and associated sleep disturbances are also common during menopause because falling hormone levels interfere with the brain’s ability to regulate body temperature.
Lynkuet works by blocking overactive nerves in the part of the brain called the hypothalamus, which acts as the body’s thermostat, explains Stephanie Faubion, MD, medical director of the Menopause Society and director of the Mayo Clinic Center for Women’s Health.
“These nerves, also called KNDy neurons, become hyperactive when they no longer receive feedback from the ovary around the time of menopause,” explains Dr. Faubion.
Lynkuet acts on two receptors in the brain, the NK3 receptor (which is involved in hot flashes) and the NK1 receptor (which is thought to play a role in regulating temperature and sleep). “This drug could have a dual benefit against hot flashes and for sleep in postmenopausal women,” explains Faubion.
Lynkuet joins Veozah as a non-hormonal treatment option
Another non-hormonal daily hot flash pill, Veozah (fezolinetant), works solely on the NK3 receptor to reduce hot flashes and night sweats while potentially improving sleep and mood, says JoAnn V. Pinkerton, MD, professor of obstetrics and gynecology and director of midlife health at the University of Virginia Health System in Charlottesville.
“Hormone therapy remains the most effective treatment for hot flashes,” says Dr. Pinkerton. But about 9 percent of women can’t take hormones because they have a history of certain types of breast cancer or other health problems, Pinkerton says.
Veozah may be a good option for some women who can’t take hormones for hot flashes, but it carries a risk of liver problems and also can’t be used by people who take certain antidepressants and antibiotics, Pinkerton says.
Although liver problems are rare with Lynkuet, according to the JAMA study, doctors always recommend liver function tests before starting this medication and again after three months of treatment, Pinkerton says.
How much will Lynkuet cost?
Without insurance, Lynkuet can cost about $650 a month, Faubion says. For people who receive health benefits, the drug may cost as little as about $25 per month.
For women experiencing hot flashes who have no medical reason to avoid hormones, the decision whether or not to try a non-hormonal option like Lynkuet may come down to personal choice, says Faubion. Cost may also be a factor.
“The approval of this drug is important because it gives women another option for managing vasomotor symptoms, and a non-hormonal option at that,” says Faubion. “While it is unlikely to be less expensive than other options initially, its mechanism of action directly addresses the cause of hot flashes in the brain.”
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