Oral Human Abuse Potential of Oxycodone DETERx®(Xtampza®ER).
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 Emaxwas 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.
Collegium Pharmaceutical Inc, Canton, MA, USA.
Ernest A
EA
Kopecky
Collegium Pharmaceutical Inc, Canton, MA, USA.
Alison B
AB
Fleming
Altreos Research Partners Inc, Toronto, Ontario, Canada.
Naama
N
Levy-Cooperman
Collegium Pharmaceutical Inc, Canton, MA, USA.
Melinda
M
O'Connor
University of Toronto and DL Global Partners Inc, Toronto, Ontario, Canada.
Edward
E
M Sellers
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000737:chemistry / Q000378:metabolism; D004311:Double-Blind Method; D004339:Drug Compounding; D005260:Female; D006801:Humans; D008297:Male; D008409:Mastication / Q000502:physiology; D008875:Middle Aged; D009293:Opioid-Related Disorders / Q000097:blood* / Q000175:diagnosis*; D010098:Oxycodone / Q000008:administration & dosage* / Q000097:blood* / Q000737:chemistry; D055815:Young Adult
D003692:Delayed-Action Preparations; D010098:Oxycodone
abuse-deterrent formulations; human abuse potential; opioids; oxycodone DETERx
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