(CNN) \u2014 The US Food and Drug Administration has approved another once-a-day pill that works without hormones to treat moderate to severe hot flashes in menopausal women, drugmaker Bayer said Friday.<\/p>\n
The drug, elinzanetant, is expected to be available in the United States beginning in November under the brand name Lynkuet, Bayer said<\/a>.<\/p>\n It works by blocking the brain chemicals responsible for hot flashes and night sweats \u2013 what doctors call vasomotor symptoms \u2013 in menopausal women. It\u2019s estimated that more than 80% of women have hot flashes during menopause.<\/p>\n \u201cThis FDA approval represents a bold step forward \u2013 our first hormone-free treatment for alleviating vasomotor symptoms of menopause,\u201d Christine Roth, Bayer\u2019s executive vice president of global product strategy and commercialization, said in a news release<\/a> Friday.<\/p>\n \u201cThere is a need for more individualized approaches to menopause care, and Lynkuet addresses a significant gap in treatment options,\u201d she said.<\/p>\n For many women, hormone therapy<\/a> can be a safe and effective treatment for menopause symptoms such as hot flashes. But some with underlying health conditions or histories, including certain cancers, are sometimes advised against using hormone replacement therapies. Experts say that for those women, alternative treatment options can be helpful.<\/p>\n A Phase 3 clinical trial<\/a> of elinzanetant that included 628 postmenopausal women found that those taking the drug for 12 weeks reported a more than 73% reduction<\/a> in the frequency of their vasomotor symptoms, or VMS. In contrast, those taking a placebo reported a 47% reduction.<\/p>\n The most common side effects in women taking the drug were drowsiness, fatigue and headaches.<\/p>\n \u201cThis yearlong study not only confirmed the initial findings of rapid and significant reduction in the frequency and severity of hot flashes and night sweats but also provided evidence that these effects were sustained over a year, offering hope for longer-term relief,\u201d researcher Dr. JoAnn Pinkerton, UVA Health\u2019s director of midlife health and emeritus executive director of the North American Menopause Society, said in a statement last month<\/a> when the trial findings were published.<\/p>\n \u201cFor those dealing with moderate to severe VMS due to menopause, the treatment options have been limited, especially for those who cannot or choose not to undergo hormone therapy,\u201d Pinkerton said. \u201cThe disruptive nature of these bothersome hot flashes, particularly when they are more severe, can significantly affect women\u2019s daily lives, both at work and at home, underscoring the urgent need for effective non-hormonal treatments.\u201d<\/p>\n Hot flashes are a sudden feeling of being very hot that\u2019s usually centered around the face, chest and head. They can also cause intense sweating and flushing that may last several minutes. When this happens at night, it\u2019s called a night sweat. Women in menopause may get them occasionally or many times a day, which can be extremely disruptive.<\/p>\n \u201cIt\u2019s important that women know they have choices for treating moderate to severe hot flashes due to menopause, and today\u2019s approval further expands a woman\u2019s options for treating these symptoms,\u201d Claire Gill, president and founder of the National Menopause Foundation, said in Bayer\u2019s announcement Friday.<\/p>\n