Tris Pharma’s Cebranopadol Shows Promising Results in Phase 3 Trial for Moderate-to-Severe Acute Pain Treatment

Positive Phase 3 Results:
Tris Pharma announced positive topline results from the ALLEVIATE-1 Phase 3 clinical trial evaluating cebranopadol, an investigational first-in-class oral dual-NMR agonist, for the treatment of moderate-to-severe acute pain following abdominoplasty surgery12.

Efficacy and Safety:
The study demonstrated a statistically significant reduction in pain intensity compared to placebo, with a favorable safety and tolerability profile comparable to placebo. The most common adverse event was nausea12.

Mechanism of Action:
Cebranopadol targets both the nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor, offering a novel approach to pain management with minimized risk of addiction and side effects124.

Future Plans:
Tris plans to submit full results from the ALLEVIATE-1 trial for presentation at an upcoming medical congress and to share results from additional studies, including an intranasal human abuse potential study and ALLEVIATE-2, a Phase 3 clinical study in patients following bunionectomy, with an NDA submission expected later in 202512.

Potential Impact:
Cebranopadol has the potential to transform the treatment landscape for patients suffering from acute pain by providing effective pain relief with a lower risk of addiction and detrimental side effects compared to opioids124.

Sources:

1. https://www.trispharma.com/tris-pharma-announces-positive-results-from-alleviate-1-phase-3-clinical-trial-of-cebranopadol-an-investigational-first-in-class-oral-dual-nmr-agonist-for-the-treatment-of-moderate-to-severe-acute-p/

2. https://www.biospace.com/press-releases/tris-pharma-announces-positive-results-from-alleviate-1-phase-3-clinical-trial-of-cebranopadol-an-investigational-first-in-class-oral-dual-nmr-agonist-for-the-treatment-of-moderate-to-severe-acute-pain

4. https://www.trispharma.com/tris-pharma-initiates-alleviate-1-and-alleviate-2-pivotal-phase-3-trials-investigating-cebranopadol-a-first-in-class-compound-with-a-novel-mechanism-of-action-to-treat-pain/