Estimating attractiveness for abuse of a not-yet-marketed "abuse-deterrent" prescription opioid formulation

Abstract

Objective: The present study builds on research to model abusers' perceptions of particular analgesics' 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's 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' 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' ratings of the overall attractiveness of these drugs. The overall model yielded a significant pseudo R2 of 0.15 (P < 0.001), with increasing model fit based on preferred route of administration, from swallowing whole (pseudo R2 = 0.06; P < 0.001) and best for those who preferred to inject (pseudo R2 = 0.40; P < 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. © American Academy of Pain Medicine.