Bayer Reports the P-III (OASIS 3) Trial Data of Elinzanetant to Treat Vasomotor Symptoms in Postmenopausal Women
Shots:
- Bayer plans to highlight full results from the P-III (OASIS 3) trial assessing elinzanetant’s (120mg, oral, QD) safety & efficacy vs PBO to treat VMS in postmenopausal women (n=628, 40-65yrs.) for 52wks. at The Menopause Society (TMS) 2024
- Trial reached the 1EP, showing no. of VMS reduction to 1.6 vs 3.4 after 12wks. (baseline: 6.7 vs 6.8) that sustained throughout the study as well as improved measures of sleep disturbances & menopause-related QoL at 52wks.
- All three P-III (OASIS 1, 2 & 3) trials have shown positive results, with findings of OASIS 1 & 2 published in the JAMA. Based on these results, Bayer has submitted NDA to the US FDA for same, with further applications seeking approval globally
Ref: Bayer | Image: Bayer
Related News:- Bayer Submits NDA of Elinzanetant, Seeking Approval in the US for Vasomotor Symptoms Treatment
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.