What's Happening?
Trevi Therapeutics, a clinical-stage biopharmaceutical company, has announced strategic updates regarding its investigational therapy Haduvio for chronic cough treatment. The company is preparing for an FDA
End-of-Phase 2 meeting in the first quarter of 2026 to discuss the development of Haduvio for chronic cough in patients with idiopathic pulmonary fibrosis (IPF). Trevi plans to initiate a Phase 2b trial for refractory chronic cough (RCC) in the first half of 2026. Haduvio, which targets opioid receptors involved in chronic cough, has shown significant reduction in cough frequency in clinical trials. The company aims to advance Haduvio closer to market availability, addressing the high unmet need for effective chronic cough treatments.
Why It's Important?
Chronic cough, particularly in patients with IPF and RCC, represents a significant unmet medical need, affecting millions in the U.S. without FDA-approved therapies. Trevi's development of Haduvio could provide a much-needed treatment option, potentially improving the quality of life for patients suffering from debilitating cough conditions. The company's progress in clinical trials and regulatory discussions with the FDA highlights the potential for Haduvio to become a key player in the chronic cough treatment landscape. Successful development and approval of Haduvio could also position Trevi as a leader in this niche market, offering new hope to patients and healthcare providers.
What's Next?
Following the FDA End-of-Phase 2 meeting, Trevi plans to initiate its Phase 3 program for Haduvio in IPF patients in the first half of 2026. The company will also start a Phase 2b trial for RCC, aiming to further validate Haduvio's efficacy and safety. Trevi's participation in the LifeSci Partners Corporate Access Event during the J.P. Morgan Healthcare Conference will provide an opportunity to engage with investors and stakeholders, potentially securing additional support for its development programs. The outcomes of these trials and regulatory discussions will be critical in determining Haduvio's path to market.
