Bayer’s investigational drug significantly reduced hot flushes in menopausal women during trial
German chemical and pharmaceutical giant Bayer AG has announced that its experimental compound elinzanetant, a non-hormonal selective neurokinin-1,3 receptor antagonist, has been shown to significantly reduce the frequency and severity of hot flushes in postmenopausal women during a phase2 trial.
In a media statement released recently, the company said that the multicentre, multicounty, double-blind, placebo-controlled, dose-range finding study of the experimental compound met its primary endpoint by demonstrating reductions in vasomotor symptoms (VMS) frequency and severity versus placebo at primary 4-week and 12-weeks against placebo.
“While menopause is a natural part of ageing for women, millions of women across the United States experience severe and bothersome hot flashes, which last for an average of nearly seven-and-a-half years,” Dr James A. Simon, clinical professor of obstetrics and gynaecology at The George Washington University School of Medicine, and lead investigator on the study said.
“We are excited about the further exploration of elinzanetant as a potential non-hormonal option for women, especially as many women may not be candidates for existing hormone therapies because of medical contraindications or due to personal preferences,” he added.
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According to the statement, the study evaluated four different doses (40mg, 80mg, 120mg, 160mg) in the mean daily frequency of moderate-to-severe VMS with elinzanetant 120 mg at week 4.
The study result reveals that participants who were given a 160 mg dose of elinzanetant showed significant improvements at week 4, but not at week 12.
“Standing for and advocating on behalf of women’s health is central to our “We’re for Her” mission at Bayer. For over 60 years, Bayer has been a leader in women’s healthcare, and this commitment spans generations, from prenatal and newborn support to contraceptive access, and the menopause transition is no different,” Dr Yesmean Wahdan, Vice President of US Medical Affairs, Bayer Women’s Healthcare said.
“Many women may experience a variety of symptoms of differing severity and duration, including vasomotor, psychological, urogenital, cardiovascular, and musculoskeletal symptoms. We are excited about moving into phase III studies investigating elinzanetant for the treatment of VMS,” she added.
According to various estimates, by 2050, more than 1.6 billion women worldwide are expected to reach menopause or be postmenopausal, up from one billion in 2020.