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– Positive results confirm findings from prior studies evaluating the abuse potential of cebranopadol, further highlighting its potential as a safe and potent alternative to traditional opioids – 

– Registrational phase 3 clinical trials of cebranopadol in moderate to severe acute pain are on track to initiate in Q4 2023 – 

MONMOUTH JUNCTION, NJ, September 5, 2023 – Business Wire – Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on ADHD, pain and neurological disorders, today announced new data from a human abuse potential (HAP) study of cebranopadol (TRN-228) which suggest the investigational compound has significantly lower abuse potential compared to both schedule II and schedule IV opioids. The findings will be shared on Thursday, September 7, in a poster presentation at the 2023 PAINWeek conference in Las Vegas.

Cebranopadol is the first and only dual nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor agonist (dual-NMR) analgesic in clinical development for the treatment of moderate to severe pain, as well as opioid use disorder (OUD). Clinical studies to date suggest that the first-in-class dual-NMR analgesic has the potential to become the first pain-relief therapy to provide efficacy equivalent to traditional opioids with significantly less potential for abuse or risk of physical dependence, addiction or overdose.

“Given that the opioid epidemic continues to have a devastating impact on a global scale and millions of people live each day with pain that is not well managed, the importance of developing novel safe and effective pain management therapies cannot be overstated,” said Ketan Mehta, founder and chief executive officer at Tris Pharma. “The data shared today validate our clinical efforts to advance cebranopadol and reinforce the potential of this investigational therapy to contribute to a future where pain can be managed without further exacerbating the impact of drug addiction.”

HAP studies are required prior to U.S. Food and Drug Administration (FDA) approval in therapeutic classes with abuse potential. The cebranopadol oral HAP study was a randomized, double-blind, five-way crossover study of 45 participants, designed to evaluate the abuse potential of cebranopadol in adult nondependent recreational opioid users versus placebo; oxycodone, a schedule II narcotic; and tramadol, a schedule IV narcotic.

Eligible participants underwent a naloxone challenge to confirm non-dependence to opioids and a qualification phase to assess that they could tolerate oxycodone and tramadol and discriminate their effects from placebo. Study participants randomly received a single dose of placebo, cebranopadol 600μg, cebranopadol 1000 μg, tramadol IR 600 mg or oxycodone IR 40 mg. The primary endpoint was maximum drug liking “at this moment,” measured using a bipolar 100-point visual analog scale (VAS). Key secondary endpoints included “overall drug liking” and “take drug again” scores measured by the VAS.

Overall, study findings suggest that cebranopadol has significantly lower abuse potential compared to schedule II and schedule IV opioids, with less likability, longer time to peak effect, fewer perceived good effects and more perceived bad effects than both oxycodone and tramadol. Specifically, maximum drug liking “at this moment” for both cebranopadol 600 μg and 1000 μg was significantly less than tramadol 600 mg (17.34 and 7.77 on the VAS, respectively; 95% confidence interval [CI]) and oxycodone 40 mg (24.43 and 14.86 on the VAS, respectively; 95% CI).

Additionally, all key secondary endpoints were consistent with cebranopadol being less preferred, including that perceived “good drug effects” associated with both the 600 μg (24.7) and 1000 μg (43.8) doses of cebranopadol were lower than both oxycodone (69.6) and tramadol (54.3), while the perceived “bad drug effects” associated with cebranopadol 600 μg (12.8) and 1000 μg (23.7) were higher than both oxycodone (7.8) and tramadol (21.2). The difference between the good effects and bad effects of drugs have been linked to their abuse potential. Also, these data were consistent with the holistic measures “overall drug liking,” where subjects rated both doses of cebranopadol lower than either of the active comparators, and “take drug again,” where subjects indicated a reduced interest in taking cebranopadol again when compared to both oxycodone and tramadol.

Based on previous studies suggesting cebranopadol provides relief for acute, chronic nociceptive and neuropathic pain that is on par with or superior to traditional opioids, these findings suggest the compound may serve as a much-needed alternative treatment option.

“These data provide further evidence that, as the first dual-NMR analgesic, cebranopadol has the potential to deliver effective pain management without the level of addictive potential seen with schedule II and schedule IV drugs,” said Marc Lesnick, Ph.D., chief development officer at Tris Pharma. “We hope that these findings are encouraging for patients and clinicians who are awaiting new options and we look forward to initiating our phase 3 clinical trials.”

About Cebranopadol (TRN-228)

Cebranopadol is the first and only full, dual nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor agonist (dual-NMR) analgesic in clinical development for the treatment of moderate to severe pain, as well as opioid use disorder (OUD). Cebranopadol offers a compelling and truly unique mechanism of action that takes advantage of the inherent properties of the NOP receptor, which has demonstrated both the potential to lessen the risk of abuse while still providing effective pain relief, and to block drugs of abuse from producing drug-seeking behaviors. In 2017, the FDA granted Fast Track Designation to cebranopadol for chronic low back pain. Cebranopadol’s profile has been well-characterized in pain management, and if approved, it could become the first and only pain-relief therapy with the demonstrated ability to provide efficacy equivalent to traditional opioids with significantly less potential for abuse or risk of physical dependence, addiction or overdose.

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 and neurological disorders, including addiction and diseases 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.

Company Contact

Cheryl Patnick
Tris Pharma, Inc.
cpatnick@trispharma.com

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Andrea Cohen
Sam Brown, Inc.
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