{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,16]],"date-time":"2026-05-16T04:49:59Z","timestamp":1778906999164,"version":"3.51.4"},"reference-count":30,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2016,11,1]],"date-time":"2016-11-01T00:00:00Z","timestamp":1477958400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Collegium Pharmaceutical Inc"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2017,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Oxycodone DETERx<jats:sup>\u00ae<\/jats:sup>(Collegium Pharmaceutical Inc, Canton, Massachusetts) is an extended\u2010release, microsphere\u2010in\u2010capsule, abuse\u2010deterrent formulation designed to retain its extended\u2010release properties after tampering (eg, chewing\/crushing). This randomized, double\u2010blind, placebo\u2010controlled, triple\u2010dummy study evaluated the oral abuse potential of intact and chewed oxycodone DETERx capsules compared with crushed immediate\u2010release oxycodone. Subjects with a history of recreational opioid use who were nondependent\/nontolerant to opioids were enrolled. Treatments included intact oxycodone DETERx (high\u2010fat, high\u2010calorie meal and fasted), chewed oxycodone DETERx (high\u2010fat, high\u2010calorie meal and fasted), crushed immediate\u2010release oxycodone (fasted), and placebo (high\u2010fat, high\u2010calorie 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\u2010eight subjects completed the study. Chewed and intact oxycodone DETERx were bioequivalent, unlike crushed immediate\u2010release oxycodone, which yielded higher peak oxycodone plasma concentrations compared with all methods of oxycodone DETERx administration. The mean maximum (peak) effect (E<jats:sub>max<\/jats:sub>) for drug liking was significantly lower for chewed and intact oxycodone DETERx than for crushed immediate\u2010release oxycodone (<jats:italic>P<\/jats:italic>&lt; .01). The time to E<jats:sub>max<\/jats:sub>was significantly longer for chewed and intact oxycodone DETERx than for crushed immediate\u2010release oxycodone (<jats:italic>P<\/jats:italic>&lt; .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\u2010release 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\u2010release oxycodone.<\/jats:p>","DOI":"10.1002\/jcph.833","type":"journal-article","created":{"date-parts":[[2016,9,27]],"date-time":"2016-09-27T07:32:58Z","timestamp":1474961578000},"page":"500-512","source":"Crossref","is-referenced-by-count":25,"title":["Oral Human Abuse Potential of Oxycodone DETERx<sup>\u00ae<\/sup>(Xtampza<sup>\u00ae<\/sup>ER)"],"prefix":"10.1002","volume":"57","author":[{"given":"Ernest A.","family":"Kopecky","sequence":"first","affiliation":[{"name":"Collegium Pharmaceutical Inc Canton MA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alison B.","family":"Fleming","sequence":"additional","affiliation":[{"name":"Collegium Pharmaceutical Inc Canton MA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Naama","family":"Levy\u2010Cooperman","sequence":"additional","affiliation":[{"name":"Altreos Research Partners Inc Toronto Ontario Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Melinda","family":"O'Connor","sequence":"additional","affiliation":[{"name":"Collegium Pharmaceutical Inc Canton MA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Edward","family":"M. 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