MONMOUTH JUNCTION, N.J. — September 10, 2026
Adneuris Therapeutics presented new clinical and abuse-potential data for cebranopadol at PAINWeek 2026, strengthening the company’s development strategy for moderate-to-severe acute pain. The investigational therapy is a first-in-class dual nociceptin/orphanin FQ peptide (NOP) and mu-opioid peptide (MOP) receptor agonist, designed to provide analgesia through a mechanism differentiated from conventional selective MOP opioid medicines. New findings presented at the meeting included a comprehensive assessment of cebranopadol’s abuse potential, while results from the pivotal Phase 3 ALLEVIATE-1 and ALLEVIATE-2 studies reinforced its efficacy across soft- and hard-tissue surgical pain models. The company said the combined evidence supports continued progress toward a planned New Drug Application (NDA) submission later in 2026, following Adneuris’ launch as a wholly owned subsidiary of Tris Pharma in July.
Cebranopadol Shows Lower Abuse Potential in Studies
Abuse potential remains a central differentiating factor for cebranopadol as Adneuris seeks to develop an alternative to conventional opioid analgesics. In recreational opioid users, doses up to 2.5 times the anticipated maximum therapeutic dose demonstrated lower abuse potential than the Schedule II opioids hydromorphone and oxycodone and the Schedule IV opioid tramadol. The broader assessment incorporated behavioral pharmacology, human abuse-potential studies, and analysis of abuse- and withdrawal-related adverse events across the clinical program. Cebranopadol was associated with a low incidence of euphoria-like events, while withdrawal-related adverse events following abrupt discontinuation were rarely reported and were not more frequent than placebo in studies lasting up to 14 weeks. Preclinical studies also indicated a lower tendency to reinforce drug-seeking behavior compared with selective MOP agonists, along with weak physical dependence potential. Drug-discrimination findings suggested that NOP receptor activity may temper MOP agonist effects, providing a mechanistic rationale for the observed abuse-potential profile.
Phase 3 ALLEVIATE Studies Demonstrate Analgesic Activity
The pivotal ALLEVIATE program provides clinical evidence supporting cebranopadol’s efficacy in moderate-to-severe acute postoperative pain. In ALLEVIATE-1, which evaluated patients undergoing abdominoplasty, cebranopadol 400µg produced a significant reduction in pain intensity from 4 to 48 hours compared with placebo, with a least-squares mean difference of -59.2 (p<0.001). In ALLEVIATE-2, conducted in patients undergoing bunionectomy, the same 400µg dose significantly reduced pain intensity from 2 to 48 hours, producing a least-squares mean difference of -56.1 (p<0.001) versus placebo. Oxycodone also demonstrated significant activity in ALLEVIATE-2, with a least-squares mean difference of -29.1 versus placebo. Across both trials, rescue medication use was significantly lower with cebranopadol, while the therapy was generally well tolerated and no drug-related serious adverse events were reported. The results across two distinct surgical models support further evaluation of cebranopadol as a potential treatment for acute pain following both soft- and hard-tissue procedures.
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Adneuris Prepares Cebranopadol for Regulatory Submission
The PAINWeek data add momentum to Adneuris’ regulatory and commercialization strategy as the company prepares for a planned NDA submission later this year. Cebranopadol’s development program is built around the potential to combine meaningful analgesic activity with a lower abuse-potential profile than traditional opioid therapies. This positioning could be particularly relevant in acute pain, where physicians must balance the need for effective relief with concerns surrounding misuse, dependence and addiction. The company is using the clinical and pharmacological evidence generated across its program to support the regulatory package for cebranopadol. Adneuris said the latest findings, together with recent strategic partnerships and continued development progress, represent important milestones since its establishment in July 2026. As a wholly owned subsidiary of Tris Pharma, Adneuris benefits from the parent company’s drug-development and commercial capabilities across pain and central nervous system disorders. The planned NDA submission represents the next major development milestone for cebranopadol and could position the dual-NOP/MOP program for regulatory evaluation as a differentiated approach to moderate-to-severe acute pain.
Source:Adneuris Therapeutics,press release
