Tris Pharma announced positive results from a Phase 1 intranasal human abuse potential (HAP) study of cebranopadol. The study showed cebranopadol, a dual nociceptin/orphanin FQ peptide (NOP) and µ-opioid peptide (MOP) receptor agonist, is significantly less abusable than oxycodone when administered intranasally. The majority of participants indicated no desire to retake cebranopadol, reinforcing previous findings on its lower abuse potential compared to oxycodone and tramadol via oral administration.
This news is impactful because it addresses a crucial unmet need in pain management: potent pain relief without the high risk of abuse associated with current opioid treatments. Cebranopadol’s dual-action mechanism, leveraging both NOP and MOP receptors, offers a new approach. Activating the NOP receptor appears to mitigate the abuse potential linked to MOP receptor agonists like oxycodone, while maintaining effective pain control. This could represent a paradigm shift in how pain, particularly moderate to severe pain, is managed clinically.
The study used a supratherapeutic dose of cebranopadol (1000 µg, 2.5 times the proposed therapeutic dose) and compared it to 40mg of oxycodone. Results revealed statistically significantly lower “drug liking” scores for cebranopadol. Secondary endpoints, including “take drug again” and “overall drug liking,” further highlighted the disparity between the two drugs. Importantly, intranasal administration of cebranopadol did not lead to faster absorption or increased “liking” compared to oral administration, suggesting limited absorption via the nasal mucosa. This contrasts sharply with oxycodone, where intranasal administration resulted in both quicker absorption and higher “drug liking.”
Cebranopadol’s positive HAP study results, combined with recent positive Phase 3 data for post-surgical pain (ALLEVIATE-1), bolster its potential to reshape the pain management landscape. Tris Pharma plans to release further Phase 3 data for bunionectomy pain (ALLEVIATE-2) in Q1 2025 and submit a New Drug Application later this year. Future studies are planned for various chronic pain conditions, potentially establishing cebranopadol as a safer and equally effective alternative to traditional opioids for a broad range of pain conditions.
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.
