Trevi Therapeutics announces results from HAP study of oral nalbuphine

Trevi Therapeutics (TRVI) announced positive results from the human abuse potential, or HAP, study of oral nalbuphine. The HAP study was a randomized, double-blind, double-dummy, active and placebo controlled five-way crossover study in recreational drug users. The study’s primary endpoint was the peak effect for “Drug Liking”, assessed on a bi-polar, 100-point visual analog scale, or VAS. The VAS scale for this endpoint ranges from strong disliking, or 0 to strong liking, or 100. Oral nalbuphine was analyzed across three different dose for its “Drug Liking” compared to the active comparator, intravenous, or IV, butorphanol, and placebo. Topline results demonstrated a statistically significant lower “Drug Liking” for the clinical doses of oral nalbuphine compared to 6mg IV butorphanol. The supratherapeutic dose of oral nalbuphine was numerically lower than the 6mg IV butorphanol for “Drug Liking” but the results were not statistically significant. “We’re very pleased with our study results,” said James Cassella, Chief Development Officer of Trevi Therapeutics. “The positive butorphanol drug liking effect versus placebo demonstrates the validity and robustness of our study design. Our clinical program has studied doses ranging from 27mg to 162mg and we believe these results are consistent with the known profile of nalbuphine. We look forward to reporting data from our two ongoing chronic cough studies in IPF and RCC, two conditions where patients continue to have a significant unmet need.”