Trevi Therapeutics announced positive topline results from its human abuse potential (HAP) study of oral nalbuphine. The study demonstrated statistically significant lower 'Drug Liking' for the clinical doses of oral nalbuphine (81mg and 162mg) compared to 6mg intravenous (IV) butorphanol.
The mean Emax for 'Drug Liking' was 71.2 for 81mg oral nalbuphine (p<0.0001 vs. butorphanol) and 74.5 for 162mg oral nalbuphine (p=0.0008 vs. butorphanol), compared to 82.3 for IV butorphanol and 51.8 for placebo. The supratherapeutic dose of 486mg oral nalbuphine was numerically lower but not statistically significant.
No serious adverse events were reported in the study, and secondary endpoints were generally consistent with the primary endpoint. These results support the conclusion that nalbuphine extended-release has a favorable abuse potential profile, which is crucial for its potential regulatory scheduling considerations.
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