Trevi Therapeutics announces positive HAP study results for oral nalbuphine; primary endpoint met at clinical doses

Trevi Therapeutics, Inc.

Primary endpoint: mean Emax for 'Drug Liking' for oral nalbuphine 81mg was 71.2 vs IV butorphanol 6mg (82.3), p<0.0001.
Oral nalbuphine 162mg also statistically significant (74.5 vs 82.3, p=0.0008); 486mg supratherapeutic dose not significant (p=0.3221).
No serious adverse events reported; secondary endpoints (e.g., 'Take Drug Again,' 'I Feel High') consistent with primary result.
Results will be included in 8-factor abuse potential analysis for nalbuphine ER as part of planned NDA submission.

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