Tris Pharma's ALLEVIATE-1 Trial Shows Promise for Cebranopadol in Pain Relief

Tris Pharma, Inc. (Tris), a biopharmaceutical company in the commercial stage, revealed encouraging topline findings from its ALLEVIATE-1 crucial Phase 3 clinical trial assessing cebranopadol, an experimental treatment, for addressing moderate-to-severe acute pain in patients post-abdominoplasty surgery. These findings contribute to the expanding research that highlights the promising effectiveness and safety profile of cebranopadol, a groundbreaking pain treatment that utilizes dual-nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor (dual-NMR) agonism.

This dual-NMR agonist could provide considerable pain alleviation similar to opioids while significantly reducing the chances of serious side effects, dependence, and addiction. It does this by utilizing the body's natural pain modulation processes and combining the pain-relieving and safety benefits of the NOP receptor with the analgesic properties of the MOP receptor.

The findings of the clinical trial showed a statistically significant decrease in pain intensity as assessed by the Pain Numeric Rating Scale (NRS) Area Under the Curve for the 44 hours post-surgery (AUC4-48) as the main outcome. In particular, administering cebranopadol 400 µg daily for two days led to a statistically significant decrease in pain intensity when compared to placebo (LS Mean difference [SE] of 59.2 [14.36]; p<0.001). Furthermore, cebranopadol was mostly well accepted and showed a positive safety profile similar to that of placebo, without any severe adverse events linked to cebranopadol.