Literature DB >> 20002324

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

Stephen F Butler1, Ryan Black, Jill M Grimes Serrano, Lesley Folensbee, Alan Chang, Nathaniel Katz.   

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 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.

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Year:  2009        PMID: 20002324     DOI: 10.1111/j.1526-4637.2009.00737.x

Source DB:  PubMed          Journal:  Pain Med        ISSN: 1526-2375            Impact factor:   3.750


  6 in total

1.  Assessment of a formulation designed to be crush-resistant in prescription opioid abusers.

Authors:  Suzanne K Vosburg; Jermaine D Jones; Jeanne M Manubay; Judy B Ashworth; Irma H Benedek; Sandra D Comer
Journal:  Drug Alcohol Depend       Date:  2012-06-20       Impact factor: 4.492

Review 2.  Drug Formulation Advances in Extended-Release Medications for Pain Control.

Authors:  Mark R Jones; Martin J Carney; Rachel J Kaye; Amit Prabhakar; Alan D Kaye
Journal:  Curr Pain Headache Rep       Date:  2016-06

3.  Risk based in vitro performance assessment of extended release abuse deterrent formulations.

Authors:  Xiaoming Xu; Abhay Gupta; Manar Al-Ghabeish; Silvia N Calderon; Mansoor A Khan
Journal:  Int J Pharm       Date:  2016-01-16       Impact factor: 5.875

Review 4.  Strategies to reduce the tampering and subsequent abuse of long-acting opioids: potential risks and benefits of formulations with physical or pharmacologic deterrents to tampering.

Authors:  Steven P Stanos; Patricia Bruckenthal; Robert L Barkin
Journal:  Mayo Clin Proc       Date:  2012-07       Impact factor: 7.616

5.  Relative Abuse of Crush-Resistant Prescription Opioid Tablets via Alternative Oral Modes of Administration.

Authors:  Stephen F Butler; Ryan A Black; Alison B Fleming
Journal:  Pain Med       Date:  2018-08-01       Impact factor: 3.750

6.  Abuse-Deterrent Opioids: A Survey of Physician Beliefs, Behaviors, and Psychology.

Authors:  Nabarun Dasgupta; John R Brown; Maryalice Nocera; Allison Lazard; Svetla Slavova; Patricia R Freeman
Journal:  Pain Ther       Date:  2021-12-06
  6 in total

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