On Monday, Trevi Therapeutics, Inc. TRVI reported topline outcomes from its Part 2a RIVER trial of Haduvio (oral nalbuphine ER) for the remedy of sufferers with refractory continual cough (N=66).
Haduvio met the first endpoint with a statistically vital discount within the goal 24-hour cough frequency of 67% from baseline and 57% on a placebo-adjusted foundation.
Haduvio demonstrated a statistically vital discount in 24-hour cough frequency of 66% within the extreme cough (20+ coughs/hour) subgroup and 68% within the average cough (10-19 coughs/hour) subgroup.
84% of Haduvio sufferers had a minimum of a 30% discount in 24-hour cough frequency vs. baseline, as in comparison with 29% of placebo sufferers, a distinction of 55%.
Additionally Learn: Why Is Cough-Targeted Trevi Therapeutics Inventory Skyrocketing On Thursday?
A statistically vital discount in 24-hour cough frequency, as measured by an goal cough monitor, was seen as early as Day 7 (27 mg BID) for sufferers on Haduvio.
Sufferers on Haduvio skilled a statistically vital enchancment in patient-reported outcomes in comparison with placebo as early as Day 7 (27 mg BID) within the Cough Severity Visible Analog Scale and the Affected person-Reported Cough Frequency.
The security outcomes of the trial had been usually according to the recognized security profile of Haduvio from earlier trials.
The most typical opposed occasions skilled included constipation, nausea, somnolence, headache, dizziness, and fatigue, and there have been no treatment-emergent severe opposed occasions.
In February, Trevi Therapeutics accomplished enrollment in its Part 2b CORAL trial of Haduvio for the remedy of continual cough in sufferers with idiopathic pulmonary fibrosis. Topline outcomes proceed to be anticipated within the first half of 2025.
Worth Motion: TRVI inventory is up 40.2% at $6.03 on the final test Monday.
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