Trevi Therapeutics Inc. filed SEC Form 8-K: Other Events
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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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 (Emax) 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*
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Placebo |
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IV butorphanol |
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Oral nalbuphine |
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Oral nalbuphine |
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Oral nalbuphine |
Mean Emax for "Drug Liking" |
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51.8 |
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82.3 |
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71.2 |
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74.5 |
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81.1 |
P-value difference |
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p<0.0001 |
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— |
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p<0.0001 |
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p=0.0008 |
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p=0.3221 |
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*All analyses performed were on the Modified Completer Population, which was prespecified in the statistical analysis plan for the primary endpoint.
Secondary Endpoints
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Placebo |
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IV butorphanol |
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Oral nalbuphine |
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Oral nalbuphine |
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Oral nalbuphine |
Mean Emax for "Take Drug Again" |
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53.4 |
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62.8 |
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71.0 |
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67.3 |
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64.2 |
Mean Emax for "I Feel High" |
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3.4 |
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77.6 |
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35.6 |
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39.3 |
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59.2 |
Mean Emax for "I Feel Good" |
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2.7 |
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71.9 |
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40.3 |
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40.8 |
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61.0 |
Secondary endpoints included pharmacodynamic markers and patient reported outcomes, which were generally consistent with the primary endpoint. No serious adverse events were reported in the study.
The results of the HAP study will be included in the 8-factor analysis of the abuse potential of nalbuphine for nalbuphine ER that would be submitted as part of any new drug application submission to inform scheduling considerations.
Forward-Looking Statements
Statements contained in this Current Report on Form 8-K regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties and actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding Trevi's business plans and objectives, including future plans or expectations for Haduvio and plans and timing with respect to clinical trials and clinical data, expectations regarding the abuse potential of Haduvio, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties regarding the success, cost and timing of Trevi’s product candidate development activities and ongoing and planned clinical trials; the risk that positive data from a clinical trial may not necessarily be predictive of the results of later clinical trials in the same or a different indication; uncertainties regarding Trevi's ability to execute on its strategy; uncertainties with respect to regulatory authorities' views as to the data from Trevi's clinical trials and next steps in the development path for Haduvio in the United States and foreign countries, uncertainties inherent in estimating Trevi's cash runway, future expenses and other financial results, including Trevi's ability to fund future operations, including clinical trials, as well as other risks and uncertainties set forth in the quarterly report on Form 10-Q for the quarter ended September 30, 2024 filed with the Securities and Exchange Commission and in subsequent filings with the Securities and Exchange Commission. All forward-looking statements contained in this Current Report on Form 8-K speak only as of the date on which they were made. Trevi undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
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.
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TREVI THERAPEUTICS, INC. |
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Date: December 3, 2024 |
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By: |
/s/ Lisa Delfini |
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Name: Lisa Delfini |
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Title: Chief Financial Officer |