Trevi Therapeutics(TRVI) Prnewswire·2024-12-03 21:05Core Viewpoint - Trevi Therapeutics announced positive results from a human abuse potential study of oral nalbuphine, indicating lower "Drug Liking" compared to butorphanol, supporting its potential as a treatment for chronic cough in idiopathic pulmonary fibrosis and refractory chronic cough [1][2][5]. Study Results - The HAP study was a randomized, double-blind, placebo-controlled trial involving recreational drug users, assessing the peak effect for "Drug Liking" on a 100-point visual analog scale [2][8]. - Statistically significant lower "Drug Liking" was observed for oral nalbuphine doses of 81mg and 162mg compared to 6mg IV butorphanol, with p-values of p<0.0001 and p=0.0008 respectively [3]. - The mean Emax for "Drug Liking" was 71.2 for 81mg and 74.5 for 162mg oral nalbuphine, compared to 82.3 for butorphanol [3]. Secondary Endpoints - Secondary endpoints showed that oral nalbuphine also had higher scores for "Take Drug Again" and lower scores for "I Feel High" and "I Feel Good" compared to butorphanol, indicating a favorable profile [4]. - No serious adverse events were reported during the study, reinforcing the safety profile of oral nalbuphine [4]. Company Insights - Trevi Therapeutics is focused on developing Haduvio (oral nalbuphine ER) for chronic cough in patients with idiopathic pulmonary fibrosis and refractory chronic cough, addressing significant unmet medical needs [1][9]. - The company plans to report data from ongoing studies for chronic cough, emphasizing the potential of nalbuphine to meet health needs without the risks associated with traditional opioids [5][6]. Market Context - Chronic cough affects approximately 140,000 patients with idiopathic pulmonary fibrosis in the U.S., with a significant percentage experiencing debilitating symptoms [10]. - Refractory chronic cough impacts 2-3 million adults in the U.S., leading to various complications and a lack of approved therapies [11].