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2318384

Results of ALLEVIATE 1 and ALLEVIATE 2 Phase 3 trials of cebranopadol, a first-in-class, dual NOP/MOP receptor agonist for the treatment of acute pain after abdominoplasty and bunionectomy

Part of Topic

Scientific Abstracts > Acute Pain

Background

Moderate to severe acute pain is a prevalent condition in the US and managing this pain, especially in the postoperative setting, remains a challenge. Existing treatments like opioids often cause side effects such as dependence, misuse, and respiratory depression, and both clinicians and patients are increasingly hesitant to use them. Cebranopadol is a first-in-class dual nociceptin/orphanin FQ peptide (NOP) and mu-opioid peptide (MOP) receptor (dual-NMR) agonist. This dual mechanism leads to potent analgesia while attenuating the negative side effects including euphoria, physical dependence, and respiratory depression of MOP agonism. These studies evaluated the safety and efficacy of cebranopadol in managing acute post-operative pain following abdominoplasty and bunionectomy.

 

Conclusions

•Cebranopadol is a first-in-class, Dual-NMR agonist that stimulates MOP, which delivers efficacy, and NOP, which adds efficacy and regulates addictive (dependence, abuse) and other safety effects (respiratory, pruritus, GI) of MOP.
•In both trials, cebranopadol achieved the primary endpoint of statistically significant pain reduction in NRS AUC and was well tolerated. In both trials, rescue medication use was significantly lower than with placebo.
•These trials represent two registrational, Phase 3 studies highlighting cebranopadol’s potential to become a valuable new therapy for acute pain management.
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