title: 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.
  
  
  METHODS
  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 R(2) of 0.15 (P < 0.001), with increasing model fit based on preferred route of administration, from swallowing whole (pseudo R(2) = 0.06; P < 0.001) and best for those who preferred to inject (pseudo R(2) = 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.
authors.affiliation: Inflexxion, Inc., Newton, Massachusetts 02464, USA. sfbutler@inflexxion.com
authors.forename: Stephen F
authors.initials: SF
authors.lastname: Butler
authors.forename: Ryan
authors.initials: R
authors.lastname: Black
authors.forename: Jill M
authors.initials: JM
authors.lastname: Grimes Serrano
authors.forename: Lesley
authors.initials: L
authors.lastname: Folensbee
authors.forename: Alan
authors.initials: A
authors.lastname: Chang
authors.forename: Nathaniel
authors.initials: N
authors.lastname: Katz
mesh_terms: D000280:Administration, Inhalation; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000701:Analgesics, Opioid / Q000008:administration & dosage; D002626:Chemistry, Pharmaceutical; D002648:Child; D003376:Counseling; D003625:Data Collection; D003692:Delayed-Action Preparations; D003710:Demography; D005260:Female; D006801:Humans; D007267:Injections; D008297:Male; D008875:Middle Aged; D008960:Models, Psychological; D009270:Naloxone / Q000008:administration & dosage; D009292:Narcotic Antagonists / Q000008:administration & dosage; D009293:Opioid-Related Disorders / Q000517:prevention & control* / Q000523:psychology*; D010098:Oxycodone / Q000008:administration & dosage; D010423:Pentazocine / Q000008:administration & dosage; D055553:Prescription Drugs; D015203:Reproducibility of Results; D012907:Smoking; D055815:Young Adult
chemical_list: D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D009292:Narcotic Antagonists; D055553:Prescription Drugs; D009270:Naloxone; D010098:Oxycodone; D010423:Pentazocine