Cebranopadol Achieves Positive Phase 3 Results for Treatment of Moderate-to-Severe Acute Pain

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Tris Pharma, Inc. has announced positive topline results from a phase 3 clinical trial evaluating cebranopadol, an investigational first-in-class therapy for the management of moderate-to-severe acute pain, according to a company news release.¹

Cebranopadol is an oral dual nociceptin/orphanin FQ peptide receptor and µ-opioid peptide receptor (dual-NMR) agonist. During the phase 3 ALLEVIATE-1 (NCT06545097) trial, the drug demonstrated a statistically significant reduction in pain intensity compared with placebo in patients following abdominoplasty surgery. This was measured by the Pain Numeric Rating Scale (NRS) area under the curve (AUC4-48). Study investigators reported that cebranopadol 400 µg once daily for 2 days achieved a mean hourly difference of 1.34 points on the NRS compared with placebo. The drug was generally well tolerated and exhibited a favorable safety profile that was comparable to placebo, with no serious adverse events. The most common was nausea.¹

“These are extremely encouraging results, emphasizing the important role cebranopadol could play in effectively and safely alleviating moderate-to-severe acute pain for patients,” said Harold Minkowitz, M.D., primary investigator in the ALLEVIATE-1 study and president of analgesics, perioperative & hospital-based research at Evolution Research Group, in the news release. “Our team was impressed by the magnitude of analgesia seen, suggesting that cebranopadol’s novel mechanism of dual-NMR agonism has the potential to be as effective as opioids in the post-surgical setting. This analgesic efficacy, combined with evidence from prior clinical studies showing low drug likability and potential for fewer respiratory events, demonstrate that cebranopadol could help address a critical unmet medical need for the millions of people who experience acute pain.”¹

“We are excited by the results from the ALLEVIATE-1 trial demonstrating a strong level of pain relief,” said Ketan Mehta, founder and chief executive officer at Tris Pharma, in the news release. “The opioid crisis has highlighted the urgent need for pain management options that treat moderate-to-severe pain as effectively as opioids but do not carry similar risk of addiction and detrimental side effects. We believe cebranopadol has the potential to transform the treatment landscape for patients suffering from acute pain.”¹

Tris Pharma plans to submit detailed ALLEVIATE-1 results for presentation at an upcoming medical congress. Additional data from an intranasal human abuse potential study and the ALLEVIATE-2 Phase 3 trial in patients following bunionectomy are expected in the first quarter of 2025. The company anticipates submitting a new drug application later this year and intends to investigate cebranopadol for multiple chronic pain indications beginning in the second half of 2025.¹

Source: Tris Pharma announces positive results from ALLEVIATE-1 phase 3 clinical trial of cebranopadol, an investigational first-in-class dual-NMR agonist, for the treatment of moderate to severe acute pain. News release. Tris Pharma. January 22, 2025. Accessed January 22, 2025. 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/