CNN – 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.
The drug, elinzanetant, is expected to be available in the United States beginning in November under the brand name Lynkuet, Bayer said.
It works by blocking the brain chemicals responsible for hot flashes and night sweats – what doctors call vasomotor symptoms – in menopausal women. It’s estimated that more than 80% of women have hot flashes during menopause.
“This FDA approval represents a bold step forward – our first hormone-free treatment for alleviating vasomotor symptoms of menopause,” Christine Roth, Bayer’s executive vice president of global product strategy and commercialization, said in a news release Friday.
“There is a need for more individualized approaches to menopause care, and Lynkuet addresses a significant gap in treatment options,” she said.
For many women, hormone therapy 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.
A Phase 3 clinical trial of elinzanetant that included 628 postmenopausal women found that those taking the drug for 12 weeks reported a more than 73% reduction in the frequency of their vasomotor symptoms, or VMS. In contrast, those taking a placebo reported a 47% reduction.
The most common side effects in women taking the drug were drowsiness, fatigue and headaches.
“Hot flashes, particularly when severe, can have an impact on women’s daily lives,” Pinkerton said in Bayer’s announcement.
“This approval provides healthcare providers with a new treatment option that can be used first-line for moderate to severe hot flashes due to menopause.”
