– Review findings show high risks associated with short-term opioid prescriptions – often the only effective option for treating moderate-to-severe acute pain – leading to misuse and/or dependence –

– Risk of chronic pain substantially increases if acute pain is not adequately managed in the short term –

– Majority of patients addicted to heroin and fentanyl started as pain patients who were prescribed an opioid –

– Review results reinforce the urgent need for innovative therapies that can treat pain as effectively as opioids but without the associated risks –

Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company, today announced the acceptance of its company-sponsored, peer-reviewed article “The burden of acute pain in the U.S. in the wake of the opioid crisis” for publication in Frontiers in Pain Research.

The paper presents critical statistics around the dilemma faced by healthcare professionals and their patients with the prescription of pain medications. Today, acute pain can often only be effectively managed by opioids, and failing to adequately manage severe acute pain substantially increases the risk of that pain becoming chronic. However, the need to utilize opioids must be balanced by their substantial risks of misuse, diversion, dependence and overdose, leaving many with untreated pain or risking it progressing and diminishing their quality of life. The need for safer, highly effective alternatives to today’s pain therapies has never been more urgent.

Key highlights from the publication include:

• ~25% of patients who receive short-term opioid prescriptions experience euphoria
• 12% (8.3 million) of adult patients who are prescribed opioids end up misusing them; this risk increases among adolescents and teenagers
• Greater than 50% of patients addicted to heroin, fentanyl and other opioids started as pain patients who felt high (i.e., experienced euphoria) upon taking an opioid medication prescribed to them and went on to misuse the medication
• Roughly 80% of heroin and fentanyl users first misused prescription opioids before seeking out a greater high
• There are approximately 80,000 opioid-related overdose deaths per year and hundreds of thousands of non-fatal opioid overdoses, which often lead to significant utilization of healthcare resources and long-term medical complications
• The total attributable cost of acute and chronic pain in the U.S. was $923 billion in 2024

“Physicians today face significant challenges when treating acute pain. Despite the availability of non-opioid options, opioids are often necessary for effective acute pain relief,” said Charles Argoff, M.D., Albany Medical College and an author of the paper. “Opioids carry inherent risks that are associated with prescribing precautions; however, completely avoiding them in the setting of severe acute pain may result in suboptimal pain reduction, increasing the likelihood of the acute pain becoming chronic. This important publication highlights the urgent need for better therapeutics so that neither physicians nor patients have to choose between effective pain relief and risks detrimental to their quality of life, including addiction.”

Details of the Publication

• Title: The burden of acute pain in the U.S. in the wake of the opioid crisis
• Authors: James C. Hackworth, Ph.D., Tris Pharma; Charles Argoff, M.D., Albany Medical College; John E. Schneider, Ph.D., Avalon Health Economics; Maggie Do Valle, MPH, Avalon Health Economics; David Fam, Pharm.D., Tris Pharma; Ema Offidani, Ph.D., Tris Pharma; Jim Potenziano, Ph.D., Tris Pharma
• Journal: Frontiers in Pain Research

Tris Pharma commissioned this research in support of its work developing cebranopadol, a dual nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor (dual-NMR) agonist.

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 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 such as cebranopadol. More information is available at www.trispharma.com and on LinkedIn @TrisPharma.

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 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.

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