Cebranopadol hemicitrate

Tris Pharma’s Wholly-Owned Subsidiary is Advancing the Development of Cebranopadol as it Prepares for New Drug Application (NDA) Submission Later This Year MONMOUTH JUNCTION, N.J., July 09, 2026 (GLOBE NEWSWIRE) -- Adneuris Therapeutics, a subsidiary of Tris Pharma, launched today to advance a bold new vision for pain medicine through the development and future commercialization of cebranopadol, its lead investigational therapy. Adneuris is built to reimagine how pain is treated, based on the belief that effective pain management requires new options for different needs, not a one-size-fits-all solution. The launch marks the next phase of Tris Pharma's growth strategy. Adneuris anticipates submitting a New Drug Application (NDA) for cebranopadol, an investigational first-in-class dual NOP/MOP receptor (dual-NMR) agonist for the treatment of moderate-to-severe acute pain. "For more than two decades, Tris Pharma has built its reputation by challenging convention and advancing medicines that address significant unmet needs," said Jim Potenziano, Ph.D., Chief Science and Development Officer of Tris Pharma. "The launch of Adneuris represents the next evolution of that commitment. We created Adneuris with a singular focus: to advance innovative science that has the potential to redefine pain management while putting patients and healthcare providers at the center of everything we do." Adneuris is built around a patient-first philosophy and a belief that effective pain management requires new approaches, not incremental improvements. Rather than relying solely on traditional opioid pathways, the company's lead investigational therapy is designed to modulate pain through both the nociceptin/orphanin FQ peptide (NOP) and mµ-opioid peptide (MOP) receptors, representing a differentiated scientific approach intended to balance strong analgesia with an improved safety profile. "The innovation gap in pain has left patients and physicians with limited choices for too long — a gap Adneuris aims to address," said Ketan Mehta, Founder and Chief Executive Officer of Tris Pharma. "Millions of Americans continue to live with inadequately treated pain, while the lasting effects of the opioid epidemic have left patients and healthcare providers navigating increasingly difficult treatment decisions. Adneuris aims to meet that need by advancing cebranopadol, which has the potential to provide meaningful pain relief through a fundamentally new approach." Cebranopadol has completed Phase 3 clinical trials for the treatment of moderate-to-severe acute pain, along with a comprehensive clinical program with more than 2,400 participants enrolled across its studies. Cebranopadol was evaluated in two pivotal Phase 3 trials — ALLEVIATE-1 (following abdominoplasty or "tummy tuck" surgery) and ALLEVIATE-2 (following bunionectomy or "bunion" surgery) — assessing its efficacy and safety in moderate-to-severe pain following soft- and hard-tissue surgical procedures. In both studies, cebranopadol demonstrated a significant reduction in pain compared with placebo over 48 hours, reduced use of opioid rescue medication compared with placebo, and sustained pain control as shown by a longer time to first rescue dose. Together, these results support cebranopadol's potential to deliver efficacy comparable to standard-of-care therapies, with a differentiated safety pro to reduce the risk of side effects associated with conventional opioid treatments such as oxycodone. 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 . 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 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). These receptors are partially homologous to each other, and they play both complementary and distinct roles to modulate pain biology pathways. Studied in over 33 clinical trials with more than 2,400 participants, cebranopadol’s pro been well characterized in pain management studies. It has demonstrated 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, misuse, addiction or overdose than selective MOP agonists such as oxycodone. Cebranopadol’s novel mechanism of action has potential in treating patients with substance use disorders (SUDs). Tris plans to continue to evaluate cebranopadol’s potential to help patients break the cycle of opioid addiction. 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