Trevi Therapeutics announced that the U.S. Food and Drug Administration has granted overall alignment on its development plan for Haduvio, the oral nalbuphine extended‑release therapy for chronic cough in idiopathic pulmonary fibrosis (IPF). The alignment covers two pivotal Phase 3 trials that will evaluate a 54 mg twice‑daily dose in IPF patients.
The FDA’s approval of the trial design is a critical regulatory milestone that de‑risks the late‑stage development of Haduvio. Chronic cough is a common and debilitating symptom of IPF, and no FDA‑approved therapy exists. Haduvio’s dual kappa agonist and mu antagonist (KAMA) mechanism targets opioid receptors that modulate the cough reflex, offering a first‑in‑class approach.
The first Phase 3 study will enroll approximately 300 patients and run for 52 weeks, while the second will enroll about 130 patients and include a 12‑week fixed‑dose period. Both trials will use objective cough monitoring to measure relative change from baseline in 24‑hour cough frequency, the primary endpoint that aligns with FDA guidance and provides robust, quantifiable data.
Trevi’s financial position supports the upcoming trials. The company’s cash reserves provide a runway that extends beyond 2026, allowing it to fund the Phase 3 program without immediate financing needs. While the company has not yet generated revenue from Haduvio, its strong cash position mitigates the financial risk associated with the large investment required for late‑stage development.
James Cassella, PhD, Chief Development Officer, said the meeting clarified the path forward and provided useful guidance on remaining Phase 1 studies. Jennifer Good, President and CEO, emphasized that the FDA alignment is a pivotal step toward addressing the unmet need for IPF‑related chronic cough, a condition that has historically offered limited therapeutic options.
Analysts have maintained a strong buy consensus on Trevi Therapeutics, with price targets ranging from $16 to $27 and an average target of $21.55. The alignment is expected to reinforce investor confidence in the company’s ability to advance Haduvio toward regulatory approval.
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