Trevi Therapeutics Reports Encouraging Outcomes from Phase 2a RIVER Trial for Haduvio Treating Chronic Cough Conditions

Positive Results from the Phase 2a RIVER Trial: A Step Forward for Chronic Cough Treatment

Trevi Therapeutics, Inc. has released positive results from its Phase 2a clinical trial known as the RIVER trial, highlighting the effectiveness of its investigational therapy, Haduvio (oral nalbuphine ER), for treating patients suffering from refractory chronic cough (RCC). This trial is crucial since RCC lacks any FDA-approved treatments in the United States, leaving millions of patients without viable solutions. The results showcase Haduvio's potential, marking a significant moment in the biopharmaceutical sector, especially in addressing a persistent medical challenge.

In the RIVER trial, which involved 66 participants, Haduvio met its primary endpoint with a statistically significant reduction in 24-hour cough frequency. The findings revealed a remarkable 57% change in cough frequency when compared to placebo, with a p-value less than 0.0001, indicating substantial efficacy. This achievement is particularly noteworthy considering that chronic cough can severely impact patients' daily lives, often leading to psychological and physical distress.

Jennifer Good, the President and CEO of Trevi Therapeutics, expressed her excitement over the trial's results, emphasizing that Haduvio demonstrates high effectiveness, even at the lowest tested dosage. She pointed to the therapy's ability to manage cough counts in a patient population that has long struggled with treatment-resistant conditions. The RIVER trial results align with previous studies indicating Haduvio's action mechanism, which targets both central and peripheral pathways involved in cough reflex, offers a dual approach to management that hasn't been realized by other therapies available today.

Dr. James Cassella, the Chief Development Officer at Trevi, reiterated the significance of the trial's outcomes, noting consistent results across both primary and secondary endpoints, particularly for patients suffering from moderate to severe coughs. This consistency builds confidence in Haduvio as a potential therapeutic option in the market.

The trial design implemented rigorous methodologies including a randomized, double-blind, placebo-controlled framework that enhances the credibility of the outcomes. During the study, patients were evaluated through different dosage increments over a 21-day treatment window, allowing researchers to analyze cough frequency changes effectively. The goal to measure cough frequency through objective monitoring at Day 21 confirmed the efficacy of Haduvio in providing relief to participants.

In terms of added positivity, 84% of patients receiving Haduvio reported at least a 30% reduction in their cough frequency compared to just 29% of those on placebo, illustrating a noteworthy therapeutic advantage. Furthermore, findings indicated improvements in patients' self-reported cough severity as early as Day 7 during the trial, giving hope for a swift relief mechanism for individuals suffering from debilitating chronic cough.

Safety profiles from the trial align with those noted in previous studies on Haduvio, showing relatively mild side effects including nausea, headaches, and fatigue, ensuring that the benefits outweigh the risks for most patients. Importantly, no serious adverse events were reported, suggesting a favorable safety trend that further supports Haduvio as a potential treatment candidate.

Looking forward, Trevi Therapeutics is optimistic about advancing Haduvio’s clinical development and plans to engage with the FDA regarding the next steps for its investigational therapy. The executives are hopeful that further studies will bring Haduvio closer to addressing the unmet needs of millions of individuals with RCC and improving their quality of life significantly.

The RIVER trial's outcomes not only open new avenues for treatment but also instill a sense of urgency among the medical community to develop reliable therapies against ailments such as refractory chronic cough that remain poorly managed in clinical settings. Chronic cough affects around 2 to 3 million people in the U.S. alone, causing significant economic and social challenges. Patients often deal with a multitude of complications including anxiety, depression, and general life disruption due to this condition.

As the company prepares for the next phases of development, there is a collective excitement in the air. With advancements in Haduvio's research and upcoming discussions with regulatory bodies, the future looks bright for both Trevi Therapeutics and the future of chronic cough management. As Professor Jacky Smith noted, the need for effective therapies in this space is dire, and the prospects of Haduvio show tremendous potential in meeting this critical market demand.

In conclusion, Trevi Therapeutics stands at the forefront of innovative therapy development, poised to alter the treatment landscape of chronic cough through Haduvio. Stakeholders await further updates as Trevi moves forward in refining and expanding this promising protocol to ultimately provide relief to those suffering from this debilitating condition.

For more detailed information, visit Trevi Therapeutics' official website.