Trevi Therapeutics Secures FDA Alignment for IPF Cough Treatment

Event summary

  • Trevi Therapeutics has completed an End-of-Phase 2 meeting with the FDA regarding its Haduvio™ (nalbuphine ER) therapy for IPF-related chronic cough.
  • The FDA has aligned with Trevi's plan to conduct two pivotal Phase 3 clinical trials, expected to begin in Q2 2026 and H2 2026, respectively.
  • The Phase 3 trials will enroll approximately 300 and 130 patients, respectively, and will assess cough frequency as a primary endpoint.
  • Haduvio is the only investigational therapy to demonstrate statistically significant cough reduction in both IPF and refractory chronic cough patients.

The big picture

Trevi’s progress represents a potential breakthrough in addressing a significant unmet need within the IPF patient population, a market estimated to be worth hundreds of millions annually. The FDA alignment de-risks the development pathway, but the success of Haduvio remains contingent on the results of the Phase 3 trials and the company’s ability to navigate the regulatory and commercial landscape. The lack of existing therapies highlights the potential for a first-mover advantage, but also underscores the pressure to deliver meaningful clinical benefit.

What we're watching

Trial Execution
The parallel Phase 3 trial design introduces complexity; successful, concurrent execution will be critical for timely data generation and potential approval.
Endpoint Validation
Reliance on an objective cough monitor as the primary endpoint necessitates careful scrutiny of its reliability and correlation with patient-reported outcomes.
Commercial Adoption
Given the limited treatment options and significant burden of IPF-related cough, the success of Haduvio will hinge on physician and patient adoption, which will be influenced by efficacy and safety data.