Adneuris Therapeutics Presents Novel Data on Lead Candidate, Cebranopadol for the Treatment of Moderate-to-Severe Acute Pain at PAINWeek 2026

Adneuris unveiled new abuse potential data demonstrating that cebranopadol's abuse potential may be lower than that of Schedule II and Schedule IV pain drugs, further differentiating its dual NOP/MOP mechanism from drugs like oxycodone.

The Phase 3 ALLEVIATE studies met their primary efficacy endpoints for cebranopadol for the treatment of moderate-to-severe acute pain, with significant reductions in pain intensity observed across both soft- and hard-tissue surgical pain models.

These data reinforce Adneuris' continued progress toward a planned New Drug Application (NDA) submission later this year.

MONMOUTH JUNCTION, N.J., Sept. 10, 2026 (GLOBE NEWSWIRE) -- Adneuris Therapeutics, a wholly owned subsidiary of Tris Pharma advancing a new kind of pain medicine, today announced novel data presented for its lead investigational therapy, cebranopadol, at PAINWeek 2026, taking place September 8-11 in Las Vegas, NV. 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 at PAINWeek 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 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 II opioids hydromorphone and oxycodone and Schedule IV opioid tramadol.
• Low incidence of euphoria and withdrawal-related events: 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 common than placebo in studies of up to 14 weeks.
• Reduced abuse-related signals in preclinical models: 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.

“Each year, roughly 80 million Americans experience acute pain¹, 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,” said James Hackworth, Ph.D., Cebranopadol Development Lead at Adneuris Therapeutics. “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 two pivotal Phase 3 studies, ALLEVIATE-1 and ALLEVIATE-2, evaluating cebranopadol for moderate-to-severe acute pain following abdominoplasty and bunionectomy, respectively.

Key findings from the Phase 3 studies include:

• ALLEVIATE-1: In a 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).
• ALLEVIATE-2: In a 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).
• Rescue medication use and tolerability: 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 adverse events 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 at PAINWeek 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.

About Adneuris Therapeutics 
Adneuris Therapeutics, a wholly owned subsidiary of Tris Pharma, is dedicated to developing new therapies for people living with pain. Guided by a patient-first approach, the company is focused on advancing innovative science with the goal of improving pain management and addressing unmet patient needs. Adneuris is committed to helping shape the future of pain care through research, collaboration, and a focus on delivering meaningful treatment options. 

For more information, visit https://adneuris.com/. 

About Tris Pharma, Inc. 
Tris Pharma, Inc. is a privately held, innovation-driven biopharmaceutical commercial-stage company that is applying drug development capabilities and proprietary technologies to transform the treatment of ADHD, pain, and disorders of the central nervous system into advanced, targeted drug delivery. Tris markets a portfolio of best-in-class ADHD products and is developing a robust pipeline of differentiated near-term drug candidates. 

For more information, visit www.trispharma.com. 

About Cebranopadol 
Cebranopadol is a first-in-class investigational therapy that targets two key receptors, the nociceptin/orphanin FQ peptide (NOP) and µ-opioid peptide (MOP) receptors (a dual-NMR agonist), for the treatment of moderate-to-severe pain, as well as opioid use disorder (OUD). Studied in over 34 clinical trials in more than 2,400 subjects, cebranopadol's profile has been well characterized in pain management studies, demonstrating positive clinical results in acute pain, chronic pain and diabetic neuropathic pain with a favorable safety profile. The FDA granted Fast Track Designation to cebranopadol for chronic low back pain, and if approved, it has the potential to become the first dual-NMR agonist to provide robust pain relief with a reduced risk of dependence, respiratory depression, or abuse potential than selective MOP agonists such as oxycodone. 

Cebranopadol's novel mechanism of action also has potential in treating patients with substance use disorders (SUDs). The National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), has awarded Tris a five-year grant of up to $16.6 million to study cebranopadol's potential to treat OUDs and SUDs. 

Contact: 
Cheryl Patnick 
Tris Pharma 
732-823-4940 

Media Contact: 
Madelin Hawtin 
LifeSci Communications 
MHawtin@lifescicomms.com  

1. Lopez, Andreaa,*; Menzie, Ann M.a; Kenderes, Michaelb; Rubin, Jaime L.a. A real-world databaseanalysis of the prevalence of pain medication use in the United States. PAIN Reports 11(1):e1396,February 2026. | DOI: 10.1097/PR9.0000000000001396 ​