Bayer (ETR: BAYN), a leading German pharmaceutical company, has announced positive results from a placebo-controlled late-stage trial of its NK-1,3 receptor antagonist, elinzanetant. The trial successfully met its primary endpoint, demonstrating a significant reduction in the frequency of moderate-to-severe vasomotor symptoms (VMS) associated with menopause by week 12. The 52-week safety profile of the drug was found to be consistent with earlier data, indicating a favorable tolerability.
These encouraging results, when combined with the data from previous Phase III studies, will be submitted to regulatory authorities for seeking marketing approval of the once-daily pill designed to treat women with moderate-to-severe VMS associated with menopause, commonly referred to as hot flashes.
According to the public data, Japan’s Astellas (TYO: 4503) is also developing a Phase III candidate for the same indication, highlighting the active research in this therapeutic area.- Flcube.com