In a notable development, Trevi has gained alignment with the FDA on its Phase 3 program for the treatment of patients with idiopathic pulmonary fibrosis (IPF)-related chronic cough following a successful End-of-Phase 2 meeting. The company plans to initiate two pivotal Phase 3 clinical trials in the second quarter of 2026, aiming to address the high unmet need for effective treatments in this area. The first trial will enroll approximately 300 patients, while the second will involve around 130 patients, both focusing on the efficacy of nalbuphine ER compared to placebo.
Additionally, Trevi is on track to initiate a Phase 2b clinical trial for the treatment of refractory chronic cough in the same timeframe. The company’s strategic focus on these clinical programs is expected to enhance its position in the market, particularly as there are currently no FDA-approved therapies for chronic cough in the targeted indications. Trevi's leadership expressed optimism about the company's trajectory, emphasizing the importance of their recent clinical data and regulatory engagements in shaping future growth.
