Estimating Attractiveness for Abuse of A Not-Yet-Marketed “Abuse Deterrent” Prescription Opioid Formulation

摘要

Objective: The present study builds on research to model abusers\u27 perceptions of particular analgesics\u27 attractiveness for abuse and extends these methods to derive an estimate of attractiveness for abuse of a not-yet-marketed abuse-deterrent formulation (ADF) of a prescription opioid (Remoxy), Pain Therapeutics, Inc., San Mateo, CA, and King Pharmaceuticals, Inc., Bristol, TN). In a previous study, the Opioid Attractiveness Technology Scaling (OATS) method identified, from a drug abuser\u27s point of view, the particular features of a prescription opioid relevant to its attractiveness for recreational use. A second online sample rated the extent to which these features applied to particular products they had actually used/abused. These data were used to model the abusers\u27 overall preference for prescription opioids they had used/abused.Design: In the present study, this method was applied to a not-yet-marketed ADF using substance abuse counselors as proxies for prescription opioid abusers. Thirty-eight counselors were given materials describing the new ADF along with four known products.Results: Thirty-two counselors demonstrated sufficient agreement with abusers\u27 ratings of the overall attractiveness of these drugs. The overall model yielded a significant pseudo R(2) of 0.15 (P \u3c 0.001), with increasing model fit based on preferred route of administration, from swallowing whole (pseudo R(2) = 0.06; P \u3c 0.001) and best for those who preferred to inject (pseudo R(2) = 0.40; P \u3c 0.001). Data from a cross-validation group of 16 counselors/proxies were used to calculate the OATS scores for the five rated drugs and revealed significant differences between the ADF and OxyContin (Purdue Pharma LP, Stamford, CT), Percocet (Endo Pharmaceuticals, Chadds Ford, PA), and Vicodin (Abbott Laboratories, Abbott Park, IL), but not Talwin NX (Sanofi-aventis, Bridgewater, NJ), which was identified in the prior study as a highly unattractive drug for recreational purposes.Conclusions: The OATS method shows promise for providing pre-marketing estimates of attractiveness for abuse of not-yet-marketed ADFs