Trevi Therapeutics Shares Promising Findings from Nalbuphine Abuse Liability Study
Trevi Therapeutics, Inc. has recently announced encouraging results from a study assessing the human abuse potential (HAP) of oral nalbuphine. The findings are pivotal as they suggest a reduced likelihood of abuse compared to currently prescribed opioids. This randomized, double-blind study involved recreational drug users and sought to determine how 'liked' oral nalbuphine was in comparison to a standard opioid, IV butorphanol, with various dosages applied. Notably, the average 'Drug Liking' score for the clinical doses of oral nalbuphine (81mg and 162mg) was significantly lower than that of IV butorphanol, indicating a promising safety profile amid rising concerns over opioid addiction. Researchers evaluated the participants using a visual analog scale where a score nearing 100 indicated strong positive feelings about the drug, and a score of 50 meant neutrality. The results revealed that oral nalbuphine scored lower in comparison to the butorphanol, making it a potential alternative for chronic cough treatment without the risk of addiction typically associated with opioids.
Dr. James Cassella, the Chief Development Officer at Trevi Therapeutics, expressed satisfaction with these findings, which are significant in informing the future treatments for chronic cough in patients suffering from idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC). Current treatment options for chronic cough in IPF are limited and provide minimal relief, creating an urgent need for effective therapies. Long-term cough is notably debilitating and can severely diminish a patient's quality of life.
The study not only asserted the reduced risk of abuse potential for nalbuphine but also indicated that it possesses a strong therapeutic profile. It was conducted in two parts. Initially, various IV butorphanol doses were examined, followed by the comparison of the drug's likability against nalbuphine. Importantly, the FDA approved the methodology to ensure a robust research design, giving credibility to the results prepared to be submitted alongside a new drug application (NDA).
This achievement reassures the public and healthcare professionals about nalbuphine's viability as a treatment option. While nalbuphine has remained unscheduled in the U.S. for decades, its potential application in addressing chronic cough without the risks associated with conventional opioids positions it favorably within the biopharmaceutical arena. Trevi Therapeutics, by advocating for the approval of Haduvio, aims to fill the significant void in treatment for patients affected by chronic cough, underscoring their commitment to providing solutions that prioritize safety and effectiveness.
In conjunction with these results, Trevi Therapeutics has plans for an upcoming conference call to review the study's topline data further. The implications of this study stretch beyond corporate interests, suggesting a meaningful public health benefit, enhancing treatment options for millions who struggle with chronic cough.
The importance of developing safer opioid alternatives cannot be overstated, especially amid the current opioid crisis. Through continuous research and innovation, Trevi is working towards providing both a medical solution and peace of mind for patients and their families alike, reinforcing the need for responsible drug development. As further data emerges from ongoing studies on chronic cough, Trevi Therapeutics remains committed to its mission of addressing unmet medical needs efficiently and safely.