Tris Pharma announced positive clinical data from its intranasal human abuse potential (HAP) study of cebranopadol. The study demonstrated that cebranopadol, a dual-nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor agonist, is significantly less likeable when snorted than oxycodone. This finding reinforces previous data showing similar low abusability via oral administration compared to oxycodone and tramadol.
This news is crucial because it addresses a critical unmet need in pain management: effective pain relief without the high risk of abuse associated with current opioid treatments. The potential for a potent analgesic with a lower abuse liability could significantly impact the opioid crisis by offering a safer alternative for patients and reducing the incidence of addiction and overdose. This directly benefits patients suffering from moderate to severe pain who require potent pain relief but fear the addictive properties of conventional opioids.
The intranasal HAP study revealed statistically significant lower drug liking for cebranopadol at a supratherapeutic dose compared to oxycodone. Key secondary endpoints, including “take drug again” and “overall drug liking,” further emphasized the difference between the two drugs. Importantly, intranasal administration of cebranopadol did not lead to faster absorption or greater liking compared to oral administration, suggesting it is primarily absorbed through the stomach. This contrasts sharply with oxycodone, where intranasal administration resulted in quicker absorption and increased drug liking. These findings support the mechanism of cebranopadol, where NOP receptor activation mitigates the abuse potential associated with MOP receptor agonists without compromising pain relief.
Cebranopadol’s positive clinical data, coupled with its recent success in a pivotal Phase 3 study for post-surgical pain, positions it as a potential game-changer in pain management. If approved, it could become the first dual-NMR agonist pain therapy offering opioid-level efficacy with a reduced risk of abuse, dependence, and overdose. This could lead to a paradigm shift in how pain is managed, offering a safer and more effective option for patients and healthcare providers. Future studies in chronic pain indications are planned, further expanding the potential reach of this promising new therapy.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
