{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,4]],"date-time":"2026-04-04T09:32:05Z","timestamp":1775295125727,"version":"3.50.1"},"reference-count":24,"publisher":"Oxford University Press (OUP)","issue":"6","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2017,6,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Objective. To evaluate the abuse potential of ALO-02, an abuse-deterrent formulation comprising pellets of extended-release oxycodone hydrochloride surrounding sequestered naltrexone hydrochloride.<\/jats:p>\n                  <jats:p>Design. Randomized, double-blind, placebo-\/active-controlled, 6-way crossover study, with naloxone challenge, drug discrimination, and treatment phases.<\/jats:p>\n                  <jats:p>Subjects. Nondependent, recreational opioid users.<\/jats:p>\n                  <jats:p>Methods. Oral administration of crushed and intact ALO-02, crushed immediate-release (IR) oxycodone, and placebo. Primary endpoints were Drug Liking and High measured on visual analog scales and reported as maximum effect (Emax) and area-under-the-effect-curve from 0 to 2\u2009hours (AUE0-2h). Other pharmacodynamic, pharmacokinetic and safety assessments were included.<\/jats:p>\n                  <jats:p>Results. Drug Liking and High (Emax) for crushed oxycodone IR 40\u2009mg were significantly higher compared with placebo, confirming study validity (P\u2009&amp;lt;\u20090.0001). Drug Liking and High (Emax, AUE0-2h) for crushed ALO-02 (40\u2009mg\/4.8\u2009mg and 60\u2009mg\/7.2\u2009mg) were significantly lower compared to corresponding doses of crushed oxycodone IR (40 and 60\u2009mg; P\u2009&amp;lt;\u20090.0001). Likewise, Drug Liking and High (Emax and AUE0-2h) for intact ALO-02 60\u2009mg\/7.2\u2009mg were significantly lower compared with crushed oxycodone IR 60\u2009mg (P\u2009&amp;lt;\u20090.0001). Secondary pharmacodynamic endpoints and plasma concentrations of oxycodone and naltrexone were consistent with these results. Fewer participants experienced adverse events (AEs) after ALO-02 (crushed or intact: 71.1\u201391.9%) compared with crushed oxycodone IR (100%). Most common AEs following crushed ALO-02 and oxycodone IR were euphoric mood, pruritus, somnolence, and dizziness.<\/jats:p>\n                  <jats:p>Conclusions. The results suggest that ALO-02 (crushed or intact) has lower abuse potential than crushed oxycodone IR when administered orally in nondependent, recreational opioid users.<\/jats:p>","DOI":"10.1093\/pm\/pnw178","type":"journal-article","created":{"date-parts":[[2016,8,22]],"date-time":"2016-08-22T22:39:10Z","timestamp":1471905550000},"page":"1077-1088","source":"Crossref","is-referenced-by-count":4,"title":["Abuse Potential Study of ALO-02 (Extended-Release Oxycodone Surrounding Sequestered Naltrexone) Compared with Immediate-Release Oxycodone Administered Orally to Nondependent Recreational Opioid Users"],"prefix":"10.1093","volume":"18","author":[{"given":"Beatrice","family":"Setnik","sequence":"first","affiliation":[{"name":"*Global Product Development, Global Innovative Pharma \u2014 Neuroscience & Pain, Pfizer Inc, Durham, NC, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Almasa","family":"Bass","sequence":"additional","affiliation":[{"name":"\u2020Global Product Development, Global Innovative Pharma \u2014 Clinical Sciences, Pfizer Inc, Durham, NC, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Candace","family":"Bramson","sequence":"additional","affiliation":[{"name":"\u2021Global Product Development, Global Innovative Pharma \u2014 Clinical Sciences, Pfizer Inc, Groton, CT, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Naama","family":"Levy-Cooperman","sequence":"additional","affiliation":[{"name":"\u00a7Early Phase, INC Research LLC, Toronto, Ontario, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bimal","family":"Malhotra","sequence":"additional","affiliation":[{"name":"\u00b6Global Product Development, Global Innovative Pharma \u2014 Clinical Pharmacology, Pfizer Inc, New York, NY, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kyle","family":"Matschke","sequence":"additional","affiliation":[{"name":"\u2016Global Product Development, Global Innovative Pharma \u2014 Statistics, Pfizer Inc., Collegeville, PA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pierre","family":"Geoffroy","sequence":"additional","affiliation":[{"name":"\u00a7Early Phase, INC Research LLC, Toronto, Ontario, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kenneth W.","family":"Sommerville","sequence":"additional","affiliation":[{"name":"*Global Product Development, Global Innovative Pharma \u2014 Neuroscience & Pain, Pfizer Inc, Durham, NC, USA"},{"name":"\u2016|Department of Neurology, Duke University Medical Center, Durham, North Carolina, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gernot","family":"Wolfram","sequence":"additional","affiliation":[{"name":"*Global Product Development, Global Innovative Pharma \u2014 Neuroscience & Pain, Pfizer Inc, Durham, NC, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2016,8,19]]},"reference":[{"key":"2025102705470005300_pnw178-B1","doi-asserted-by":"crossref","first-page":"287","DOI":"10.5055\/jom.2009.0029","article-title":"Chronic opioid therapy issues associated with opioid abuse potential","volume":"5","author":"Smith","year":"2009","journal-title":"J Opioid Manag"},{"key":"2025102705470005300_pnw178-B2","first-page":"1","article-title":"Drug-poisoning deaths involving opioid analgesics: United States, 1999-2011","volume":"166","author":"Chen","year":"2014","journal-title":"NCHS Data Brief"},{"key":"2025102705470005300_pnw178-B3","author":"Substance Abuse and Mental Health Services Administration, Center for Behavioral Health Statistics and Quality","year":"2013"},{"key":"2025102705470005300_pnw178-B4","doi-asserted-by":"crossref","first-page":"435","DOI":"10.1007\/s40258-014-0102-0","article-title":"Estimating the costs of opioid abuse and dependence from an employer perspective: A retrospective analysis using administrative claims data","volume":"12","author":"Rice","year":"2014","journal-title":"Appl Health Econ Health Policy"},{"key":"2025102705470005300_pnw178-B5","doi-asserted-by":"crossref","first-page":"611","DOI":"10.3109\/03639045.2012.680468","article-title":"Current approaches in tamper-resistant and abuse-deterrent formulations","volume":"39","author":"Mastropietro","year":"2013","journal-title":"Drug Dev Ind Pharm"},{"key":"2025102705470005300_pnw178-B6","author":"U. 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