ALLEVIATE-2 Phase 3 Results: Significant Pain Reduction in Cebranopadol-Treated Patients Following Bunionectomy Surgery (Businesswire) - Mar 6, 2025 - P3 | N=240 | ALLEVIATE-2 (NCT06423703) | Sponsor: Tris Pharma, Inc | "Tris plans to submit New Drug Application to FDA in 2025..."The results of the ALLEVIATE-2 clinical study achieved its primary endpoint of demonstrating a statistically significant reduction in pain intensity as measured using the Pain Numeric Rating Scale (NRS) Area Under the Curve for two to 48 hours (AUC2-48) following dosing. Specifically, treatment with oral cebranopadol 400 µg once per day resulted in a statistically significant reduction in pain intensity compared to placebo...Additionally, cebranopadol was generally well tolerated and exhibited a favorable safety profile, with no serious adverse events observed. The most common adverse event was nausea."
FDA filing • P3 data • Pain
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