Trevi Therapeutics Publishes Key Results of Nalbuphine ER Trial
Trevi Therapeutics announced that the key results from the Phase 2b CORAL trial of oral nalbuphine ER for the treatment of chronic cough in patients with IPF have been published in the Journal of the American Medical Association. "The publication of these positive Phase 2b results with nalbuphine ER in JAMA represents an important validation of the trial findings and highlights the significance of chronic cough in patients with IPF," said James Cassella, CDO. "The statistically-significant reduction in 24-hour objective cough frequency across all dose groups shows the potential that nalbuphine ER has for the treatment of chronic cough in patients with IPF. We look forward to continuing the development of nalbuphine ER, and thank all the patients, investigators, and study staff, who have participated in our clinical trials to get us to this point." The safety results of the CORAL trial were generally consistent with the known safety profile of nalbuphine ER from previous trials. Discontinuation rates due to adverse events were similar in the combined nalbuphine ER dose groups and placebo group. The most common adverse events experienced included: nausea, vomiting, constipation, dizziness, headache, fatigue, somnolence, and dry mouth. Serious adverse events were reported for four patients in the placebo group and for two patients treated with nalbuphine ER.
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Trevi Therapeutics Reports Positive Phase 2b Results for Nalbuphine ER, Over 60% Cough Frequency Reduction at Week 6
- Clinical Trial Results: Trevi Therapeutics announced in JAMA that the Phase 2b CORAL trial demonstrated a statistically significant reduction in 24-hour cough frequency at Week 6, with over 60% of patients achieving at least a 50% reduction, indicating nalbuphine ER's potential for treating chronic cough in IPF patients.
- Patient-Reported Consistency: The consistency between patient-reported cough frequency and objective monitoring results highlights that patients not only experienced fewer coughs but also reported overall improvements, underscoring the significant burden chronic cough imposes on IPF patients' quality of life.
- Safety Results: The safety profile of the CORAL trial was consistent with previous nalbuphine ER studies, with discontinuation rates due to adverse events at 5.6% for nalbuphine ER and 5.0% for placebo, indicating a favorable safety profile for the drug.
- Market Demand: With approximately 150,000 IPF patients in the U.S., two-thirds of whom suffer from uncontrolled chronic cough, there is a pressing need for effective treatment options, and the development of nalbuphine ER could address this unmet medical need.
Trevi Therapeutics Reports Significant Cough Frequency Reduction with Nalbuphine ER in Phase 2b Trial
- Clinical Trial Results: Trevi Therapeutics published Phase 2b CORAL trial results in JAMA, showing statistically significant reductions in 24-hour objective cough frequency across all nalbuphine ER dose groups at Week 6, indicating the drug's potential for treating chronic cough in patients with idiopathic pulmonary fibrosis (IPF).
- Patient Response Consistency: Over 60% of patients treated with nalbuphine ER achieved at least a 50% reduction in 24-hour cough frequency by Week 6, with patient-reported outcomes aligning with objective monitoring results, underscoring the drug's clinical value and overall patient improvement.
- Safety Analysis: The safety profile from the CORAL trial was consistent with previous studies, showing a 5.6% discontinuation rate due to adverse events in the nalbuphine ER group, comparable to 5.0% in the placebo group, indicating good safety for further development.
- Market Demand: With approximately 150,000 patients suffering from IPF in the U.S., two-thirds of whom experience uncontrolled chronic cough, the development of nalbuphine ER addresses this significant unmet medical need and has the potential to enhance patient quality of life while reducing morbidity and mortality risks.
