Adneuris Therapeutics has announced novel data presented for its lead investigational therapy, cebranopadol. The data demonstrating cebranopadol’s potential efficacy in moderate-to-severe acute pain and reduced abuse potential, add to the growing body of evidence supporting its differentiated profile as an investigational, first-in-class, dual nociceptin/orphanin FQ peptide (NOP) and Mu-Opioid Peptide (MOP) receptor (dual-NMR) agonist.

Among the new data presented are results from a comprehensive abuse potential assessment of cebranopadol. The assessment drew on behavioral pharmacology and human abuse potential studies, along with an analysis of abuse- and withdrawal-related Adverse Events (AEs) across a large-scale clinical program.

Key findings from the abuse potential include data demonstrating lower abuse potential. In recreational opioid users, cebranopadol at doses up to 2.5 times the anticipated maximum therapeutic dose showed lower abuse potential compared with Schedule 2 opioids hydromorphone and oxycodone and Schedule IV opioid tramadol.

It further showed low incidence of euphoria and withdrawal-related events. Cebranopadol was associated with a low incidence of euphoria-like events, while withdrawal-related AEs following abrupt discontinuation were rarely reported and were not more common than placebo in studies of up to 14 weeks.

Besides, preclinical studies showed cebranopadol had a lower tendency to reinforce drug-seeking behavior than selective MOP agonists, along with weak physical dependence potential. Drug discrimination studies further indicated that cebranopadol’s NOP receptor activity tempers MOP agonist effects, a mechanism believed to underlie its reduced abuse potential.

Taken together, the data suggest cebranopadol may have a meaningfully lower abuse potential than selective full and partial MOP agonists, a critical body of evidence for the company as it moves toward NDA submission.

James Hackworth, PhD, Cebranopadol Development Lead, Adneuris Therapeutics, said, “Each year, roughly 80 million Americans experience acute pain, and for too many, effective pain relief can come with concerns about the dependence, addiction and misuse associated with drugs like oxycodone. That is the challenge we built Adneuris to address. Cebranopadol was developed with a fundamentally different approach. Through its dual NOP/MOP receptor mechanism, it is designed to provide meaningful pain relief while potentially mitigating many of the risks associated with existing treatments. These data further reinforce that differentiated profile and add to the growing body of evidence supporting cebranopadol’s potential to fill in a critical treatment gap for patients and physicians managing moderate-to-severe acute pain with the promise of a better benefit-risk profile. As we advance toward our planned NDA submission later this year, we remain focused on building the evidence needed to potentially change how moderate-to-severe acute pain is treated.”

Adneuris also presented results from its 2 pivotal phase 3 studies, ALLEVIATE-1 and ALLEVIATE-2, evaluating cebranopadol for moderate-to-severe acute pain following abdominoplasty and bunionectomy, respectively.

In ALLEVIATE-1 study, evaluating participants undergoing abdominoplasty, cebranopadol 400µg demonstrated a significant reduction in pain intensity from 4-48 hours compared with placebo (LS mean difference -59.2; p<0.001).

In ALLEVIATE-2 study, evaluating participants undergoing bunionectomy, cebranopadol 400µg demonstrated a significant reduction in pain intensity from 2-48 hours compared with placebo (LS mean difference -56.1; p<0.001). Oxycodone also demonstrated a significant reduction versus placebo (LS mean difference -29.1; p=0.031).

Across both studies, rescue medication use was significantly lower with cebranopadol compared with placebo (p<0.001). Cebranopadol was well tolerated, with no drug-related serious AEs reported.

Together, the ALLEVIATE studies demonstrate cebranopadol's potential to provide effective analgesia across both soft- and hard-tissue surgical pain models, supporting its development as a treatment option for moderate-to-severe acute pain.

The data presented further support cebranopadol’s potential as a differentiated treatment for moderate-to-severe acute pain and mark another important step forward for Adneuris since its launch in July 2026. Together with the company’s recent strategic partnerships and progress toward a planned NDA submission later this year, the presentations reflect Adneuris’ continued momentum in advancing cebranopadol.