Trevi Therapeutics Files 8-K Report

TL;DR

Trevi Therapeutics filed a routine 8-K, no major news.

AI Summary

On December 3, 2024, Trevi Therapeutics, Inc. filed an 8-K report. The filing indicates that the company is providing information under "Other Events" and is not reporting on any specific material events like acquisitions, financings, or executive changes. The report is a standard current report filed with the SEC.

Why It Matters

This filing is a routine update to the SEC, indicating no major new developments or material events to report for Trevi Therapeutics as of December 3, 2024.

Risk Assessment

Risk Level: low — This is a standard SEC filing with no new material information or significant corporate actions disclosed.

Key Players & Entities

• Trevi Therapeutics, Inc. (company) — Registrant
• December 3, 2024 (date) — Date of report

FAQ

Key Financial Figures

• $0.001 — e on which registered Common stock, $0.001 par value per share TRVI The Nasdaq

Filing Documents

• trvi-20241203.htm (8-K) — 80KB
• 0000950170-24-132883.txt ( ) — 201KB
• trvi-20241203.xsd (EX-101.SCH) — 28KB
• trvi-20241203_htm.xml (XML) — 5KB

01 Other Events

Item 8.01 Other Events On December 3, 2024, Trevi Therapeutics, Inc., a Delaware corporation (the "Company"), announced positive results from the human abuse potential ("HAP") study of oral nalbuphine. The HAP study was a randomized, double-blind, double-dummy, active and placebo controlled five-way crossover study in recreational drug users. The study's primary endpoint was the peak effect (E max ) for "Drug Liking" ("at this moment"), assessed on a bi-polar, 100-point visual analog scale ("VAS"). The VAS scale for this endpoint ranges from strong disliking (0) – neither like nor dislike (50) – to strong liking (100). Oral nalbuphine was analyzed across three different doses (ranging from a low dose to a supratherapeutic dose) for its "Drug Liking" compared to the active comparator, intravenous ("IV") butorphanol, and placebo. Topline results demonstrated a statistically significant lower "Drug Liking" for the clinical doses of oral nalbuphine (81mg and 162mg) compared to 6mg IV butorphanol. The supratherapeutic dose of oral nalbuphine (486mg) was numerically lower than the 6mg IV butorphanol for "Drug Liking" but the results were not statistically significant. Primary Endpoint* Placebo (N=52) IV butorphanol 6mg (N=52) Oral nalbuphine 81mg (N=52) Oral nalbuphine 162mg (N=52) Oral nalbuphine 486mg (N=52) Mean E max for "Drug Liking" 51.8 82.3 71.2 74.5 81.1 P-value difference vs IV butorphanol 6mg p<0.0001 — p<0.0001 p=0.0008 p=0.3221 *All analyses performed were on the Modified Completer Population , which was prespecified in the statistical analysis plan for the primary endpoint. Secondary Endpoints Placebo (N=52) IV butorphanol 6mg (N=52) Oral nalbuphine 81mg (N=52) Oral nalbuphine 162mg (N=52) Oral nalbuphine 486mg (N=52) Mean E max for "Take Drug Again" 53.4 62.8 71.0 67.3 64.2 Mean E max for "I Feel High" 3.4 77.6 35.6 39.3 59.2 Mean E max for "I Feel Good" 2.7 71.9 40.

Forward-Looking Statements

Forward-Looking Statements

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. TREVI THERAPEUTICS, INC. Date: December 3, 2024 By: /s/ Lisa Delfini Name: Lisa Delfini Title: Chief Financial Officer

View Full Filing

View this 8-K filing on SEC EDGAR