Shots:
- Tris has reported topline data from P-III (ALLEVIATE-2) trial in post-bunionectomy pts, plus additional data from P-III (ALLEVIATE-1) trial in post-abdominoplasty pts. Data from both trials, plus HAP studies will support the US FDA’s NDA filing in 2025
- ALLEVIATE-2 evaluated cebranopadol (400µg QD, PO) vs oxycodone (10mg QID, PO) vs PBO, meeting its 1EP of reduced pain intensity (NRS AUC 2-48hrs.) with higher mean activity than oxycodone. It also met its 2EP, with 57.5% pts avoiding opioid rescue vs 28.4% with PBO
- Adding to topline data (Jan 2025), ALLEVIATE-1 also showed cebranopadol-arm pts required fewer rescue doses vs PBO. P-III results to be presented at future meeting
Ref: Businesswire | Image: Tris Pharma
Related News:- Tris Pharma Reports the P-III (ALLEVIATE-1) Study Results of Cebranopadol to Treat Moderate-to-Severe Acute Pain
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