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NEWS
Trevi Therapeutics Announces Positive Topline Results from Human Abuse Potential Study of Oral Nalbuphine
1 minute ago, 1:05 PM PST
Via PR Newswire
Statistically significant lower "Drug Liking" for the 81mg and 162mg doses of oral nalbuphine vs. butorphanol covering our clinical dose range
1 minute ago, 1:05 PM PST
Via PR Newswire
Statistically significant lower "Drug Liking" for the 81mg and 162mg doses of oral nalbuphine vs. butorphanol covering our clinical dose range
NEW HAVEN, Conn., Dec. 3, 2024 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of patients with chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), today announced positive results from the human abuse potential (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 (Emax) for "Drug Liking" ("at this moment"), assessed on a bi-polar, 100-point visual analog scale (VAS). The VAS scale for this endpoint ranges from strong disliking (0) – to neither like nor dislike (50) – to strong liking (100). Oral nalbuphine was analyzed across three different doses (ranging from a low dose to a supratherapeutic dose) for its "Drug Liking" compared to the active comparator, intravenous (IV) butorphanol, and placebo. Topline results demonstrated a statistically significant lower "Drug Liking" for the clinical doses of oral nalbuphine (81mg and 162mg) compared to 6mg IV butorphanol. The supratherapeutic dose of oral nalbuphine (486mg) was numerically lower than the 6mg IV butorphanol for "Drug Liking" but the results were not statistically significant.
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 (Emax) for "Drug Liking" ("at this moment"), assessed on a bi-polar, 100-point visual analog scale (VAS). The VAS scale for this endpoint ranges from strong disliking (0) – to neither like nor dislike (50) – to strong liking (100). Oral nalbuphine was analyzed across three different doses (ranging from a low dose to a supratherapeutic dose) for its "Drug Liking" compared to the active comparator, intravenous (IV) butorphanol, and placebo. Topline results demonstrated a statistically significant lower "Drug Liking" for the clinical doses of oral nalbuphine (81mg and 162mg) compared to 6mg IV butorphanol. The supratherapeutic dose of oral nalbuphine (486mg) was numerically lower than the 6mg IV butorphanol for "Drug Liking" but the results were not statistically significant.
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