- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
Abuse-Deterrent Pain Drug Fails to Meet Primary Endpoint in Mid-Stage Trial
Regulatory submission delayed (August 26)
Disappointing results have been reported from a phase II study that assessed the abuse liability of “snorting” a crushed tablet of hydrocodone bitartrate with acetaminophen formulated with abuse-deterrent technology (Aversion H&A, Acura Pharmaceuticals).
The painkiller did not show statistically significant results in reducing likability among abusers.
The primary endpoint indicated that Aversion H&A had slightly lower numeric mean maximum drug liking (Emax: 72.1) compared with an equivalent dose of a generic hydrocodone/acetaminophen tablet (Emax: 75.6) currently on the market. These results, however, were not statistically significant (P > 0.025).
Secondary endpoints demonstrated the effects of the Aversion ingredients on drug “snorting.” Aversion H&A’s mean minimum drug liking (Emin: 40.2) was less than that for generic H&A (Emin: 50.4; P = 0.0003) and the placebo control (Emin: 48.8, P = 0.0042). A score below 50 indicates that subjects disliked the drug they were taking at some point during the treatment; a score of 50 means neither like nor dislike; and a score greater than 50 indicates that they liked the drug they were taking.
Given the absence of statistical significance in the primary endpoint relating to maximum drug liking, the timeline for submission of a New Drug Application (NDA) for Aversion H&A is expected to be delayed pending discussions with the FDA.
Source: Acura Pharmaceuticals; August 26, 2013.