The Food and Drug Administration has approved a new pill for menopausal women to treat hot flashes and night sweats.
Menopause occurs when a woman’s ovaries stop producing reproductive hormones, typically in their early 50s. While there are several uncomfortable side effects, hot flashes and night sweats are the most common, according to the National Menopause Foundation. Up to 80 percent of menopausal women experience hot flashes and night sweats, The New York Times reports.
Drug manufacturer Bayer created the first-ever FDA-approved non-hormonal medication to combat hot flashes and night sweats that blocks two kinds of brain receptors that affect temperature regulation.
The drug, called Elinzanetant, sold under the brand name Lynkuet, was approved by the FDA Friday to treat moderate-to-severe vasomotor symptoms, commonly known as hot flashes and night sweats.
“The FDA approval of Lynkuet is an important new option for women and providers who are treating moderate to severe hot flashes due to menopause,” Dr. Yesmean Wahdan, Bayer’s head of medical affairs in the U.S. and North America, said in a statement.
“As a global leader in women’s healthcare with more than 100 years of research and experience, we are proud to bring this new treatment option to market for women who are going through menopause and seeking hot flash relief.”
The drug was approved in the United Kingdom by the Medicines and Healthcare products Regulatory Agency in July, making it the first regulator in the world to do so. It is now also approved in Australia, Canada and Switzerland.
The FDA approval comes after three Phase III clinical trials, which test the safety and how well a new drug works. The trials showed that Lynkuet significantly reduced the frequency and severity of hot flashes and night sweats. The drug may also help with sleep issues.
Common side effects include headache, fatigue and stomach pain.
Lynkuet, along with other non-hormonal menopause symptom treatments, gives an option for women who either can’t or are uncomfortable using hormone therapy.
Bayer said the drug is expected to be available in the U.S. by November. The drug costs $625 for a 30-day supply, but some patients could pay as little as $25, according to the company.
