Tris Pharma to Debut Positive Results of Intranasal (Snorting) Human Abuse Potential Study of Cebranopadol, an Investigational First-In-Class Oral Dual-NMR Agonist for the Treatment of Moderate-to-Severe Pain, at the 2025 CPDD Annual Meeting

MONMOUTH JUNCTION, N.J.--(BUSINESS WIRE)--Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company, today announced that the company will present intranasal human abusability data from cebranopadol, an investigational first-in-class oral dual NOP/MOP (dual-NMR) agonist, at the College on Problems of Drug Dependence (CPDD) Annual Meeting, taking place June 14-18, 2025, in New Orleans.

The data will be presented in a late-breaking oral session and a poster presentation which highlight the significantly lower abuse potential of cebranopadol compared to established opioids such as oxycodone (Schedule II) and tramadol (Schedule IV). The late-breaking oral session will highlight positive results from an intranasal human abuse potential study demonstrating that snorting cebranopadol was significantly less liked compared to oxycodone. These results expand on an earlier study that demonstrated cebranopadol has significantly less oral abuse potential than oxycodone (Schedule II) and tramadol (Schedule IV). The poster presentation summarizes all key data to date that characterize the low abuse potential of cebranopadol. Overall, these studies support the novel mechanism of action of cebranopadol, where NOP receptor activation minimizes the potential abusability associated with MOP receptor agonists.

“These results demonstrate the potential of cebranopadol, and likely other dual-NMR agonists, to change how we treat pain while reducing the risk of misuse,” said Ketan Mehta, founder and CEO at Tris Pharma. “We continue to believe in the promise of cebranopadol to transform the lives of patients with moderate-to-severe pain as evidenced by data that show strong efficacy as well as significantly lower abusability than existing options.”

“The dangerous practice of crushing and insufflating opioids, often a progression from recreational use and a precursor to the use of more potent substances, underscores the critical need for analgesic alternatives with reduced potential for misuse,” said Megan Shram, Ph.D., an expert on human abuse potential studies. “This research indicates that cebranopadol exhibits a distinct pharmacological profile compared to conventional opioids such as oxycodone, and neither the oral nor intranasal administration of cebranopadol has demonstrated the capacity to produce reinforcing (i.e., euphoric) effects typically observed with high abuse liability opioids. These findings suggest that the treatment of pain with cebranopadol may offer an improved public health safety profile and more favorable risk-benefit ratio compared to traditional opioid analgesics.”

Tris Pharma Presentations

Poster Presentation

• Poster Presentation: Abuse Potential Assessment of Cebranopadol, a Novel Dual Nociceptin (NOP) and Mu Opioid (MOP) Receptor (dual-NMR) Agonist: Implications for Scheduling
• Presenter: Joseph Grieco, M.S., Ph.D., Vice President of Clinical Development
• Date/Time: Sunday, June 15, 2025, at 5:00PM – 6:30PM CT
• Location: Napoleon Ballroom CD, Third Floor

Late-Breaking Oral Session

• Oral Session: A Double-Blind, Randomized, Crossover Study to Assess the Abuse Potential of Intranasal Cebranopadol Compared to Oxycodone and Placebo in Healthy, Nondependent Recreational Opioid Users
• Presenters: Joseph Grieco, M.S., Ph.D., Vice President of Clinical Development
• Date and Time: Monday, June 16, 2025, at 1:45PM – 3:00PM CT
• Location: Grand Ballroom B, Fifth Floor

Grant Funding

Research reported in this press release was supported by the National Institute on Drug Abuse of the National Institutes of Health under Award Number UG3DA059285. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About Acute Pain
Acute pain affects millions of patients each year and is caused by injury, surgery, illness, trauma, burns or painful medical procedures, which can last up to three months, and typically resolves once the underlying cause is treated or healed. Moderate-to-severe acute pain can often only be effectively treated with conventional opioid analgesics such as oxycodone, especially following joint replacements and other orthopedic procedures, invasive surgeries, and major traumas and burns.

About Cebranopadol (TRN-228)
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 in more than 2,200 patients, cebranopadol’s profile has 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 could become the first dual-NMR pain-relief therapy with the demonstrated ability to provide efficacy similar to conventional opioids with less potential for misuse or risk of physical dependence, addiction or overdose.

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.

About Tris Pharma
Tris Pharma is a privately held, innovation-driven biopharmaceutical company that is applying its drug development capabilities and proprietary technologies to transform the treatment of ADHD, pain, addiction and disorders of the central nervous system. Tris markets a portfolio of best-in-class ADHD products and is developing a promising pipeline of differentiated, near-term drug candidates. More information is available at www.trispharma.com and on LinkedIn @TrisPharma.