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Oral Human Abuse Potential of Oxycodone DETERx® (Xtampza® ER).

Authors
  • Kopecky, Ernest A1
  • Fleming, Alison B1
  • Levy-Cooperman, Naama2
  • O'Connor, Melinda1
  • M Sellers, Edward3
  • 1 Collegium Pharmaceutical Inc, Canton, MA, USA.
  • 2 Altreos Research Partners Inc, Toronto, Ontario, Canada. , (Canada)
  • 3 University of Toronto and DL Global Partners Inc, Toronto, Ontario, Canada. , (Canada)
Type
Published Article
Journal
Journal of clinical pharmacology
Publication Date
Apr 01, 2017
Volume
57
Issue
4
Pages
500–512
Identifiers
DOI: 10.1002/jcph.833
PMID: 27669664
Source
Medline
Keywords
License
Unknown

Abstract

Oxycodone DETERx® (Collegium Pharmaceutical Inc, Canton, Massachusetts) is an extended-release, microsphere-in-capsule, abuse-deterrent formulation designed to retain its extended-release properties after tampering (eg, chewing/crushing). This randomized, double-blind, placebo-controlled, triple-dummy study evaluated the oral abuse potential of intact and chewed oxycodone DETERx capsules compared with crushed immediate-release oxycodone. Subjects with a history of recreational opioid use who were nondependent/nontolerant to opioids were enrolled. Treatments included intact oxycodone DETERx (high-fat, high-calorie meal and fasted), chewed oxycodone DETERx (high-fat, high-calorie meal and fasted), crushed immediate-release oxycodone (fasted), and placebo (high-fat, high-calorie meal). Plasma samples were collected to determine pharmacokinetic parameters. The primary endpoint was drug liking at the moment; other endpoints included drug effects questionnaire scores, Addiction Research Center Inventory/Morphine Benzedrine Group score, pupillometry measurements, and safety. Thirty-eight subjects completed the study. Chewed and intact oxycodone DETERx were bioequivalent, unlike crushed immediate-release oxycodone, which yielded higher peak oxycodone plasma concentrations compared with all methods of oxycodone DETERx administration. The mean maximum (peak) effect (Emax ) for drug liking was significantly lower for chewed and intact oxycodone DETERx than for crushed immediate-release oxycodone (P < .01). The time to Emax was significantly longer for chewed and intact oxycodone DETERx than for crushed immediate-release oxycodone (P < .0001). Scores for feeling high and Addiction Research Center Inventory/Morphine Benzedrine Group scores demonstrated lower abuse potential for chewed and intact oxycodone DETERx compared with crushed immediate-release oxycodone. Study treatments were well tolerated; no subjects experienced serious adverse events. These results demonstrate the lower oral abuse potential of chewed and intact oxycodone DETERx than crushed immediate-release oxycodone.

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