Tris Pharma announces positive results from ALLEVIATE-1 trial of cebranopadol

Phase 3 trial shows promising pain relief for acute pain patients

Tris Pharma, Inc. has announced positive results from its ALLEVIATE-1 phase 3 clinical trial evaluating cebranopadol for treating moderate-to-severe acute pain following abdominoplasty surgery.

The trial achieved its primary endpoint of significantly reducing pain intensity compared to placebo.

The study’s results demonstrated a strong pain relief of 1.34 mean hourly difference from placebo on the NRS scale.

Cebranopadol’s safety and tolerability profile were comparable to placebo, showing its potential as a highly effective treatment for acute pain.

“These results emphasize the important role cebranopadol could play in safely alleviating acute pain,” said Harold Minkowitz, M.D., the primary investigator in the ALLEVIATE-1 study. “Our team was impressed by the magnitude of analgesia seen, suggesting cebranopadol’s potential to be as effective as opioids.”

Ketan Mehta, CEO of Tris Pharma, expressed excitement about the trial’s strong level of pain relief. He highlighted the urgent need for pain management options that treat pain as effectively as opioids but without the risk of addiction and side effects.

“We believe cebranopadol has the potential to transform the treatment landscape for acute pain patients,” Mehta said.

Tris Pharma plans to present the full results at an upcoming medical congress. In Q1 2025, they also aim to share results from two additional studies, with an NDA submission expected later this year.

The company plans to conduct further studies on cebranopadol in multiple chronic pain indications beginning in the second half of 2025.