Non-Hormonal Relief With Elinzanetant From Bayer
We may not know what’s happening inside our bodies when we wake with fever and aches from head to toe, but we can’t wait for our favorite pain reliever to help us feel better.
Pending FDA approval, millions of women tormented by Vasomotor Symptoms (hot flashes and night sweats) - many day in and day out for years - will be able to find relief from Elinzanetant, an exciting new non-hormonal drug from Bayer HealthCare Pharmaceuticals. The company recently submitted a New Drug Application to the FDA based on positive results from Phase 3 studies evaluating the efficacy and safety of Elinzanetant compared to placebo.
Scientifically minded women might be interested to learn that this new drug is thought to work on hot flashes associated with menopause by regulating a group of estrogen-sensitive neurons in the brain’s hypothalamus region. This part of the brain controls many bodily functions, including reproduction and temperature adjustment, which compares the body’s current temperature with the normal temperature.
When estrogen levels decline during the late perimenopause and menopause, the estrogen-sensitive neurons become overgrown and go into "overdrive," disrupting the body’s ability to control heat mechanisms. Hence, hot flashes!
Study findings showed that women who orally took Elizanetant significantly reduced the frequency and severity of moderate to severe hot flashes and night sweats. The drug exhibited a “favorable safety profile.”
What’s more, Elinzanetant also “improved sleep disturbances and menopause-related quality of life,” Bayer reported.
Study Details
Two randomized double blind, placebo controlled phase 3 trials conducted across 77 sites in the U.S., Canada, Europe, and Israel
796 naturally or surgically postmenopausal patients aged 40 to 65 experiencing moderate to severe vasomotor symptoms
Patients experienced at least 50 moderate-to-severe day and night VMS over the last seven days during screening. Moderate hot flashes have sweating; severe hot flashes have sweating and disturb activity, like waking you from a sound sleep.
Participants received either 120 mg of Elizanetant or placebo once daily for 12 weeks followed by Elizanetant for 14 additional weeks
Takeaways
Elizanetant significantly reduced the frequency of moderate to severe VMS from baseline to week one ("that's fast," Bayer reported), four and 12.
Severity of VMS was reduced significantly from baseline to weeks four and 12
Sleep disturbances and menopause-related quality of life were significantly improved
“Half of the world’s population will experience menopause with 27 million women in the U.S. currently experiencing this transition. Despite the impact menopausal symptoms may have on women’s health and quality of life, many go without treatment due to gaps in awareness, education, and limitations of treatment options available,” said Christine Roth, Bayer executive vice president.
“The study results have clinically relevant implications because vasomotor symptoms often pose significant impacts on a woman’s overall health, everyday activities, sleep, quality of life, and work productivity,” wrote the study’s authors, including Dr. James Simon, co-founder of M.D. For You.
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