title: Abuse rates and routes of administration of reformulated extended-release oxycodone: initial findings from a sentinel surveillance sample of individuals assessed for substance abuse treatment.
abstract: Oxycodone hydrochloride controlled-release, also known as extended-release oxycodone (ER oxycodone), was reformulated with physicochemical barriers to crushing and dissolving intended to reduce abuse through nonoral routes of administration (ROAs) that require tampering (eg, injecting and snorting). Manufacturer shipments of original ER oxycodone (OC) stopped on August 5, 2010, and reformulated ER oxycodone (ORF) shipments started August 9, 2010. A sentinel surveillance sample of 140,496 individuals assessed for substance abuse treatment at 357 U.S. centers between June 1, 2009, and March 31, 2012, was examined for prevalence and prescription-adjusted prevalence rates of past-30-day abuse via any route, as well as abuse through oral, nonoral, and specific ROAs for ER oxycodone and comparators (ER morphine and ER oxymorphone) before and after ORF introduction. Significant reductions occurred for 8 outcome measures of ORF versus OC historically. Abuse of ORF was 41% lower (95% CI: -44 to -37) than historical abuse for OC, with oral abuse 17% lower (95% CI: -23 to -10) and nonoral abuse 66% lower (95% CI: -69 to -63). Significant reductions were not observed for comparators. Observations were consistent with the goals of a tamper resistant formulation for an opioid. Further research is needed to determine the persistence and generalizability of these findings.
  
  
  CONCLUSIONS
  This article presents preliminary findings indicating that 8 outcome measures of abuse of a reformulated ER oxycodone were lower than that for original ER oxycodone historically, particularly through nonoral ROAs that require tampering (ie, injection, snorting, smoking), in a sentinel sample of individuals assessed for substance use problems for treatment planning.
authors.affiliation: Inflexxion, Inc, 320 Needham St., Newton, MA 02464, USA. sfbutler@inflexxion.com
authors.forename: Stephen F
authors.initials: SF
authors.lastname: Butler
authors.forename: Theresa A
authors.initials: TA
authors.lastname: Cassidy
authors.forename: Howard
authors.initials: H
authors.lastname: Chilcoat
authors.forename: Ryan A
authors.initials: RA
authors.lastname: Black
authors.forename: Craig
authors.initials: C
authors.lastname: Landau
authors.forename: Simon H
authors.initials: SH
authors.lastname: Budman
authors.forename: Paul M
authors.initials: PM
authors.lastname: Coplan
mesh_terms: D000328:Adult; D000701:Analgesics, Opioid / Q000008:administration & dosage*; D002626:Chemistry, Pharmaceutical; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009293:Opioid-Related Disorders / Q000453:epidemiology* / Q000517:prevention & control*; D010098:Oxycodone / Q000008:administration & dosage*; D015995:Prevalence; D018571:Sentinel Surveillance; D055815:Young Adult
chemical_list: D000701:Analgesics, Opioid; D010098:Oxycodone