{"id":106811,"date":"2025-10-30T22:37:11","date_gmt":"2025-10-30T22:37:11","guid":{"rendered":"https:\/\/www.newsbeep.com\/il\/106811\/"},"modified":"2025-10-30T22:37:11","modified_gmt":"2025-10-30T22:37:11","slug":"fda-approves-nonhormonal-pill-for-menopausal-hot-flashes","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/il\/106811\/","title":{"rendered":"FDA Approves Nonhormonal Pill for Menopausal Hot Flashes"},"content":{"rendered":"

The U.S. Food and Drug Administration (FDA) has approved a new nonhormonal pill to treat moderate to severe hot flashes<\/a> \u2014 a common menopause symptom.<\/p>\n

Lynkuet (elinzanetant) is the first medication in a new family of medicines that directly target brain receptors responsible for temperature regulation, the drugmaker Bayer said in a statement. Lynkuet will be available by prescription in the United States starting next month, according to Bayer.<\/p>\n

[1]<\/p>\n

\u201cHaving safe and effective nonhormonal options for treatment of bothersome hot flashes is tremendously important,\u201d says JoAnn E. Manson, MD, MPH, DrPH<\/a>, a professor at Harvard Medical School and the chief of preventive medicine at Brigham and Women\u2019s Hospital in Boston.<\/p>\n

\u201cMany women are not candidates for hormone therapy because of a history of an estrogen-sensitive cancer or other medical condition, and some women would simply prefer to avoid taking hormones,\u201d Dr. Manson says. \u201cThe expanding arsenal and toolbox of nonhormonal treatment options for those with moderate to severe hot flashes is good news for women.\u201d<\/p>\n

Lynkuet Reduced Daily Hot Flashes by 55 Percent in TrialsIn late-stage studies of women with moderate to severe hot flashes, researchers randomly assigned participants to take either Lynkuet or a placebo pill. With Lynkuet, women experienced 55 percent fewer daily hot flashes on average, and the episodes they did have were much less severe, according to findings published in JAMA.<\/p>\n

[2]<\/p>\n

While the study wasn\u2019t designed to assess sleep issues<\/a>, researchers also found that Lynkuet was associated with fewer sleep disturbances and improved quality of life.<\/p>\n

Common side effects included headache and fatigue, per the JAMA study.<\/p>\n

How Lynkuet Works for Hot Flashes<\/p>\n

In the years leading up to menopause<\/a>, the ovaries gradually slow production of the hormones estrogen and progesterone, a process that eventually ends menstrual cycles. It can also cause symptoms<\/a> ranging from vaginal dryness and mood swings to joint pain, memory trouble, and insomnia.<\/p>\n

Hot flashes and night sweats (called vasomotor symptoms<\/a>), and related sleep disturbances, are also prevalent during menopause because falling hormone levels interfere with the brain\u2019s ability to regulate body temperature.<\/p>\n

Lynkuet works by blocking overactive nerves in the part of the brain called the hypothalamus, which acts as the body\u2019s thermostat, says Stephanie Faubion, MD<\/a>, the medical director of the Menopause Society and the director of the Mayo Clinic Center for Women’s Health.<\/p>\n

\u201cThese nerves, also known as KNDy neurons, become overactive when they no longer receive feedback from the ovary at the time of menopause,\u201d says Dr. Faubion.<\/p>\n

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 both temperature and sleep regulation). \u201cThis drug may have a dual benefit for hot flashes and for sleep in menopausal women,\u201d Faubion says.<\/p>\n

Lynkuet Joins Veozah as a Nonhormonal Treatment Option<\/p>\n

Another nonhormonal daily pill for hot flashes, Veozah (fezolinetant)<\/a>, works on just the NK3 receptor to reduce hot flashes and night sweats while also potentially improving sleep and mood, says JoAnn V. Pinkerton, MD<\/a>, a professor of obstetrics and gynecology and the director of midlife health at the University of Virginia Health System in Charlottesville.<\/p>\n

\u201cHormone therapy<\/a> remains the most effective treatment for hot flashes<\/a>,\u201d Dr. Pinkerton says. But about 9 percent of women can\u2019t take hormones because they have a history of certain types of breast cancer or other health issues, Pinkerton says.<\/p>\n

Veozah may be a good option for some women who can\u2019t take hormones for hot flashes, but it carries a risk of liver problems and also can\u2019t be used by individuals who take certain antidepressants and antibiotics, Pinkerton says.<\/p>\n

While liver issues are rare with Lynkuet, according to the JAMA study, doctors still recommend liver function tests before starting this medicine and again after three months of treatment, Pinkerton says.<\/p>\n

How Much Will Lynkuet Cost?<\/p>\n

Without insurance, Lynkuet may cost around $650 a month, Faubion says. For people who do have health benefits, it\u2019s possible the drug might cost as little as about $25 a month.<\/p>\n

For women living with hot flashes who have no medical reason to avoid hormones, the decision about whether to try a nonhormonal option like Lynkuet may come down to a personal choice, Faubion says. Cost might be a factor, too.<\/p>\n

\u201cThe approval of this drug is important because it offers women another option for management of vasomotor symptoms, and a nonhormonal option at that,\u201d Faubion says. \u201cWhile 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.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"The U.S. Food and Drug Administration (FDA) has approved a new nonhormonal pill to treat moderate to severe…\n","protected":false},"author":2,"featured_media":106812,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33],"tags":[163,85,46,482],"class_list":{"0":"post-106811","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medication","8":"tag-health","9":"tag-il","10":"tag-israel","11":"tag-medication"},"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts\/106811","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/comments?post=106811"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts\/106811\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/media\/106812"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/media?parent=106811"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/categories?post=106811"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/tags?post=106811"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}