Home

Tris Pharma to Unveil Positive Phase 3 Results including a Strong Safety Profile Showcasing the Potential of Cebranopadol, an Investigational First-in-Class Dual-NMR Agonist for the Treatment of Pain, at the 2025 ASRA Annual Meeting

via Business Wire

– Clinical data supporting cebranopadol’s strong efficacy and safety profile in the treatment of moderate-to-severe pain will be featured in three poster presentations –

– Positive results from ALLEVIATE-1 Phase 3 pivotal trial for cebranopadol will be presented that demonstrate statistically significant pain reduction compared to placebo in patients after abdominoplasty –

– Results demonstrating cebranopadol’s significantly lower abuse potential than Schedule II (oxycodone) and Schedule IV (tramadol) opioids, as well as 25% less respiratory depression and slower onset of respiratory depression as compared to oxycodone, will also be presented –

– A symposium on dual-NMR agonists, a promising new analgesic class for treating pain, will be hosted by Tris Pharma and feature leading industry researchers –

Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company, today announced data from cebranopadol, the company’s investigational dual-NMR agonist for the treatment of moderate-to-severe pain, featured in three poster presentations during the 50th Annual Regional Anesthesiology and Acute Pain Medicine Meeting (ASRA), taking place May 1-3, 2025, in Orlando, Florida.

The poster presentations will highlight clinical trial results demonstrating the efficacy and safety of cebranopadol, reinforcing its potential as a much-needed novel treatment option for patients with moderate-to-severe acute pain. Tris Pharma will also host a symposium focused on dual-NMR agonism, a promising new mechanism of action in treating pain. Dual-NMR agonists have the potential to treat moderate-to-severe pain as effectively as opioids, and due to its novel mechanism, it can potentially do so with significantly lower risks of abuse, addiction and overdose.

“We’re excited to present positive results from one of the pivotal Phase 3 clinical trials of cebranopadol in acute pain, as well as multiple safety studies, that reinforce the promise of cebranopadol to address the critical need for safe and effective treatment options,” said Ketan Mehta, founder and CEO at Tris Pharma. “Cebranopadol’s first-in-class mechanism of action continues to prove itself as a uniquely effective and well-tolerated approach to pain management, combining the effects of both the NOP and MOP receptors to deliver potent analgesia with reduced risk of typical opioid-related side effects. We look forward to sharing more about the innovation behind dual-NMRs with the pain community.”

Poster Presentations

Presentation: The Effects of Cebranopadol on Ventilatory Drive, Central Nervous System, and Pain

  • Presenter: James Hackworth, Ph.D., Chief Business Officer at Tris Pharma
  • Date/Time: Thursday May 1, 2025, from 1:30PM – 3:30PM ET
  • Location: MP03, Gatlin A3

Presentation: Results of a Randomized, Placebo-Controlled, Phase 3 Trial of Cebranopadol for the Treatment of Acute Pain After Abdominoplasty

  • Presenter: Marc Lesnick, Ph.D., Chief Development Officer at Tris Pharma
  • Date/Time: Thursday May 1, 2025, at 5:15PM ET
  • Location: EXP-01, Screen 9, Exhibit Hall

Presentation: Limited Oral Abuse Potential of Cebranopadol, a Novel Potent Analgesic, Compared to Tramadol and Oxycodone in Recreational Opioid Users

  • Presenter: James Hackworth, Ph.D., Chief Business Officer at Tris Pharma
  • Date/Time: Friday May 2, 2025, at 9:39AM ET
  • Location: EXP-04, Screen 6, Exhibit Hall

Symposium Highlighting Novel Pain Mechanism

Tris Pharma’s symposium will feature a series of presentations focused on dual-NMR agonism, a promising investigational new mechanism of action designed to treat moderate-to-severe pain as effectively as opioids with less potential for abuse, addiction and overdose. The symposium will be presented as part of the congress by scientists with extensive experience in novel pain therapy research and development.

Details of the Dual-NMR Symposium

  • Symposium: BREAK THE MOLD in Pain Biology: Can We Harness a New Mechanism to Overcome the Current Shortfalls in the Management of Severe Acute Pain?
  • Presenters: Roberto Ciccocioppo, Ph.D., School of Pharmacy University of Camerino, Italy; Jeffrey Gudin, M.D., University of Miami Miller School of Medicine
  • Location: Gaitlin B
  • Date and Time: May 2, 2025, at 12:15PM – 1:00PM

Tris Booth Details

At ASRA, Tris Pharma executives and company representatives will be available at Booth 310 to provide additional information about results presented at the congress.

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 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 equivalent to 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 is an established commercial organization with a robust portfolio of best-in-class ADHD products and a promising pipeline of differentiated, near-term drug candidates. More information is available at www.trispharma.com and on LinkedIn @TrisPharma.

Contacts