8-K: Trevi Therapeutics Reports Positive Results from Human Abuse Potential Study of Oral Nalbuphine

Trevi Therapeutics announces promising results from a study evaluating the abuse potential of oral nalbuphine, showing statistically significant lower 'Drug Liking' compared to an active comparator.

Summary

• Trevi Therapeutics announced positive results from a human abuse potential (HAP) study of oral nalbuphine on December 3, 2024.
• The study was a randomized, double-blind, placebo-controlled, five-way crossover trial conducted on recreational drug users.
• The primary endpoint measured 'Drug Liking' on a 100-point visual analog scale, with oral nalbuphine showing statistically significant lower scores compared to intravenous butorphanol at clinical doses.
• The study evaluated three doses of oral nalbuphine (81mg, 162mg, and 486mg) and compared them to 6mg IV butorphanol and placebo.
• No serious adverse events were reported during the study.
• The results will be included in an 8-factor analysis for nalbuphine ER as part of a potential new drug application submission.

Sentiment

Score: 8

Explanation: The study results are positive and support regulatory progress, but uncertainties remain regarding future trials and regulatory approval.

Positives

• The study demonstrated statistically significant lower 'Drug Liking' for clinical doses of oral nalbuphine compared to IV butorphanol.
• No serious adverse events were reported, indicating a favorable safety profile.
• The results support the potential for nalbuphine ER to be considered for regulatory approval with abuse potential data included.

Negatives

• The supratherapeutic dose of 486mg oral nalbuphine did not achieve statistical significance in 'Drug Liking' compared to IV butorphanol.

Risks

• Uncertainties remain regarding the success, cost, and timing of future clinical trials and product development.
• Regulatory authorities may have differing views on the data and next steps for nalbuphine ER.
• There is a risk that positive data from this study may not predict results in future trials or different indications.

Future Outlook

Trevi Therapeutics plans to include the study results in an 8-factor analysis for nalbuphine ER as part of a potential new drug application submission, with the aim of addressing abuse potential considerations.

Management Comments

• The company expressed confidence in the study results and their potential to support regulatory submissions for nalbuphine ER.

Industry Context

The study results align with the pharmaceutical industry's focus on developing medications with lower abuse potential, addressing a critical need in the opioid and pain management market.

Comparison to Industry Standards

• The results position Trevi Therapeutics favorably compared to other companies developing abuse-deterrent formulations, such as Purdue Pharma and Collegium Pharmaceutical.
• The statistically significant findings for 'Drug Liking' are competitive with industry benchmarks for abuse potential studies.

Stakeholder Impact

• Shareholders may benefit from the positive study results, which could support regulatory approval and commercialization.
• Regulatory authorities will use the study data to assess the abuse potential of nalbuphine ER.

Next Steps

• Trevi Therapeutics will include the study results in an 8-factor analysis for nalbuphine ER.
• The company plans to submit the analysis as part of a new drug application to regulatory authorities.

Key Dates

Keywords

Trevi Therapeutics, oral nalbuphine, human abuse potential study, HAP study, Drug Liking, nalbuphine ER, clinical trial, abuse potential, pharmacodynamics, regulatory submission