title: The abuse potential of Remoxy(®), an extended-release formulation of oxycodone, compared with immediate- and extended-release oxycodone.
abstract: OBJECTIVE
  Remoxy(®) is a water-insoluble, highly viscous oral formulation of oxycodone extended release (ER) currently in development. The primary objective was to determine the abuse potential of Remoxy under fed conditions relative to oxycodone ER and immediate release (IR) under fasted conditions and compared with placebo (treatment group X). A secondary objective was to evaluate abuse potential under reversed fed/fasted conditions (treatment group Y).
  
  
  METHODS
  Phase I randomized double-blind triple-dummy placebo- and active-controlled 6-way crossover study. Setting.  A single US site. PATIENTS.  Healthy men and women aged 18-50 years who were nondependent, recreational opioid users. Interventions.  Remoxy 40 mg whole and chewed, oxycodone ER 40 mg whole and crushed, oxycodone IR 40 mg crushed, and placebo.
  
  
  METHODS
  The primary endpoint was the drug liking subscale of the drug effects questionnaire assessed by various pharmacodynamic parameters. Secondary endpoints included additional pharmacodynamic measures, chewing duration, and safety measures.
  
  
  RESULTS
  In treatment group X, Remoxy whole (fed) and chewed (fed) had a significantly lower abuse potential compared with oxycodone ER (crushed, fasted) and IR (fasted) based on the majority of pharmacodynamic parameters of interest for the primary endpoint (drug liking subscale) as well as secondary endpoints. Treatment group Y showed generally similar results.
  
  
  CONCLUSIONS
  The abuse potential of Remoxy when taken whole or chewed was significantly lower than two comparators with known abuse potential, including oxycodone IR and crushed oxycodone ER, under the fed/fasted conditions tested. Remoxy may be associated with a reduced risk potential for abuse.
authors.affiliation: King Pharmaceuticals, Inc., Cary, NC, USA. beatrice.setnik@kingpharm.com
authors.forename: Beatrice
authors.initials: B
authors.lastname: Setnik
authors.forename: Carl L
authors.initials: CL
authors.lastname: Roland
authors.forename: Jody M
authors.initials: JM
authors.lastname: Cleveland
authors.forename: Lynn
authors.initials: L
authors.lastname: Webster
mesh_terms: D000293:Adolescent; D000328:Adult; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000009:adverse effects*; D002626:Chemistry, Pharmaceutical; D018592:Cross-Over Studies; D004304:Dosage Forms; D004311:Double-Blind Method; D005215:Fasting; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009270:Naloxone / Q000008:administration & dosage; D009292:Narcotic Antagonists / Q000008:administration & dosage; D009293:Opioid-Related Disorders; D010098:Oxycodone / Q000008:administration & dosage* / Q000009:adverse effects* / Q000031:analogs & derivatives*; D010919:Placebos; D011795:Surveys and Questionnaires; D055815:Young Adult
chemical_list: D000701:Analgesics, Opioid; D004304:Dosage Forms; D009292:Narcotic Antagonists; D010919:Placebos; D009270:Naloxone; D010098:Oxycodone