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

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.

Sources:globenewswire.combenzinga.comseekingalpha.comstocktitan.netsimplywall.stgurufocus.cominvesting.combarchart.combusinesswire.com