On Monday, Trevi Therapeutics, Inc. TRVI reported topline results from its Phase 2a RIVER trial of Haduvio (oral nalbuphine ER) for the treatment of patients with refractory chronic cough (N=66).

Haduvio met the primary endpoint with a statistically significant reduction in the objective 24-hour cough frequency of 67% from baseline and 57% on a placebo-adjusted basis.

Haduvio demonstrated a statistically significant reduction in 24-hour cough frequency of 66% in the severe cough (20+ coughs/hour) subgroup and 68% in the moderate cough (10-19 coughs/hour) subgroup.

84% of Haduvio patients had at least a 30% reduction in 24-hour cough frequency vs. baseline, as compared to 29% of placebo patients, a difference of 55%.

Also Read: Why Is Cough-Focused Trevi Therapeutics Stock Skyrocketing On Thursday?

A statistically significant reduction in 24-hour cough frequency, as measured by an objective cough monitor, was seen as early as Day 7 (27 mg BID) for patients on Haduvio.

Patients on Haduvio experienced a statistically significant improvement in patient-reported outcomes compared to placebo as early as Day 7 (27 mg BID) in the Cough Severity Visual Analog Scale and the Patient-Reported Cough Frequency.

The safety results of the trial were generally consistent with the known safety profile of Haduvio from previous trials.

The most common adverse events experienced included constipation, nausea, somnolence, headache, dizziness, and fatigue, and there were no treatment-emergent serious adverse events.

In February, Trevi Therapeutics completed enrollment in its Phase 2b CORAL trial of Haduvio for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis. Topline results continue to be expected in the first half of 2025.

Price Action: TRVI stock is up 40.2% at $6.03 at the last check Monday.

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