Hot flashes, sleep disorders… The symptoms of menopause, sometimes very strong and difficult to live with, were until now relieved by hormonal treatments, aimed at compensating for the drop in estrogen levels, responsible for these disorders. But a new chemical compound, tested for several years by the pharmaceutical laboratory Bayer, could, perhaps, change the situation. Elinzanetant, that’s its name, has the advantage of working without hormones. The group announced last week that the Journal of the American Medical Association had just published the conclusive results of its phase 3 trials. This stage precedes the application for marketing authorization.
How does it work?
Elinzanetant is, precisely, “a selective antagonist of neurokinin-1,3 receptors” (NK1 and NK3). At menopause, certain neurons, which use neurokinin as a neurotransmitter, are over-activated by the drop in estrogen levels. However, estrogen plays a role in body thermoregulation. The molecule will act on the neurokinin-1,3 receptors to “block the signaling pathway of these neurons”, explains to France Inter gynecologist Florence Trémollières, director of the menopause center at the Toulouse University Hospital, allowing regulation of hot flashes and vasomotor symptoms as a whole, as well as sleep disorders associated with menopause. The treatment would be administered orally once a day.
How effective is it?
In two phase 3 clinical trials, elinzanetant “demonstrated statistically significant reductions in the frequency and severity of VMS compared to placebo,” the publication in the Journal of the American Medical AssociationAfter 26 weeks, “more than 80% of participants had achieved a reduction of at least 50% in the frequency” of their symptoms, an effectiveness already visible in the fourth week of treatment.
Elinzanetant also improved sleep disturbances and menopause-related quality of life compared to placebo. At the start of the study, participants had moderate sleep disturbances on average. After treatment, mean scores “were returned to the normal range,” the publication said. No liver toxicity was observed in either study, Bayer said.
What is the benefit of non-hormonal treatment?
“Due to individual risk factors, medical contraindications, or personal preferences, there is an unmet need for additional safe and effective nonhormonal treatments for menopausal vasomotor symptoms that may also improve sleep disturbances and quality of life,” study author JoAnn Pinkerton said in a statement. “These positive results from OASIS 1 and 2 reinforce the idea that elinzanetant is a potential nonhormonal treatment option for women with menopausal vasomotor symptoms.”
What next for the Elinzan?
Bayer’s clinical trial results consider the molecule “effective and well tolerated” for the treatment of “moderate to severe” vasomotor symptoms associated with menopause. They must now be verified and approved by health authorities, before elinzanetant can be placed on the market. Bayer says it has already submitted this application for marketing authorization to the American Food and Drug Association (FDA), before requesting other authorizations.