Trevi Therapeutics Gains FDA Alignment for Phase 3 Trials of Nalbuphine ER

Key Facts

1Trevi Therapeutics successfully completed its End-of-Phase 2 meeting with the FDA.

2The company will conduct two Phase 3 clinical trials of nalbuphine ER for IPF-related chronic cough.

3Alignment was reached with the regulatory body regarding the clinical development program.

Trevi Therapeutics (TRVI) announced the successful completion of its End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA). The regulatory body has reached an alignment with the company regarding the clinical development program for its lead candidate, nalbuphine ER. Consequently, the company is set to initiate two Phase 3 clinical trials aimed at treating chronic cough associated with Idiopathic Pulmonary Fibrosis (IPF). This milestone significantly de-risks the development path for the drug, providing a clear framework for late-stage testing and potential approval. Investors view this regulatory progress as a critical step toward commercialization and market entry. The successful transition to Phase 3 underscores the therapeutic potential of nalbuphine ER in addressing unmet medical needs in respiratory care.