• Rachelle D Rodriguez, Taryn Dailey Govoni, Venkat Rajagopal, and Jody L Green.
• Janssen Pharmaceuticals, LLC, Raritan, NJ, USA.
• Curr Med Res Opin. 2023 Apr 1; 39 (4): 579587579-587.

ObjectiveOriginal brand extended-release (ER) oxycodone tablets (OC) for oral use were reformulated (ORF) with abuse-deterrent properties (ADP) against inhalation and injection routes in August 2010. This product transition provided an opportunity to compare "before and after" reformulation abuse trends. Our goal was to assess the change in abuse of brand oxycodone ER from before and after introduction of ORF.MethodsChange in self-reported non-oral "OxyContin" abuse in the previous 30 days during two years pre- and four years post-reformulation was assessed among adults evaluated for substance use and treatment planning using the Addiction Severity Index-Multimedia Version (ASI-MV). Comparator opioids were used to provide a frame of reference for changes in abuse due to competing population-level opioid abuse interventions and other factors unrelated to the reformulation. A proportion (PR) and abuse report dispensing ratio (ARDR) are reported because a single measure of abuse has not been identified that can optimally describe opioid abuse or changes in opioid abuse.ResultsInterrupted time-series analyses indicated an immediate decline in non-oral abuse measures post-reformulation (PR = -52.1%; ARDR = -32.2%). Significant decreases from pre- to post-reformulation in non-oral abuse overall were observed (PR [95% CI] = -30.7% [-46.9%, -9.5%]; ARDR = -29.3% [-37.5%, -20.1%]). Comparator opioids did not demonstrate similar trends over the period.ConclusionsMethodology applied in this study suitably assessed the effectiveness of an ADP product. Among individuals assessed for substance use, a differential decline in non-oral abuse of brand ER oxycodone was observed since introduction of ORF.

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