Opioid use following the introduction of an extended-release oxycodone formulation with tamper-resistant properties: Prospective historical chart review in methadone-maintained patients

Authors

  • Christopher Sankey, MD, CCFP (EM)
  • Beatrice Setnik, PhD
  • Zoltan Harsanyi, BSc (Hon), MLS, MBA, PStat. (SSC), PSTAT® (ASA)
  • Ken Michalko, PharmD, MBA
  • Zejiang Yang, PhD
  • Pierre Geoffroy, MDCM, MSc, FCFP, DABAM

DOI:

https://doi.org/10.5055/jom.2016.0327

Keywords:

oxycodone, opioid abuse, tamper-resistant formulation, urine drug screen, methadone maintenance therapy

Abstract

Objective: Emerging data are demonstrating that tamper-resistant opioids may play an important role in changing prescription opioid abuse behaviors. This study was a chart review to examine if the reformulation of OxyContin® into a version with tamper-resistant properties (OxyNEO®) had an impact on oxycodone-positive urine drug screens (UDSs) in opioid-dependent patients receiving methadone maintenance therapy (MMT).

Design: The historical element of this study examined 250 eligible charts from patients on MMT who had data during the time periods when only OxyContin was available (baseline period), during the transition to OxyNEO, and when only OxyNEO was available. The prospective element included an exploratory questionnaire regarding retrospective opioid use.

Setting: The study was conducted at three methadone clinics, in Oshawa, Peterborough, and Scarborough in Ontario, Canada.

Participants: Male and female patients were eligible if they had a diagnosis of opioid dependency, received MMT, and had at least one oxycodone-positive UDS during the baseline period.

Intervention: This was a noninterventional study.

Main outcome measure: The main outcome was the number of oxycodone-positive UDSs.

Results: The results demonstrated a marked reduction in oxycodone-positive UDSs that showed stepwise, statistically significant decreases during the transition and post-OxyContin periods relative to baseline. While the oxycodone-positive UDS results were decreasing, morphine-related-positive UDSs remained relatively stable during the same periods. There were no significant gender differences noted.

Conclusions: The introduction of OxyNEO was associated with a statistically significant reduction in oxycodone exposure in a population of methadone-maintained patients.

Author Biographies

Christopher Sankey, MD, CCFP (EM)

Physician, Satellite Comprehensive Care Addictions Clinic, Toronto, Ontario, Canada; Vice Chair, OMA Section of Addiction Medicine, Toronto, Ontario, Canada; Medical Director, First Step Clinics, Toronto, Ontario, Canada; Lecturer, Department of Family and Community Medicine, University of Toronto, Toronto, Ontario, Canada; Staff, Centre for Addiction and Mental Health, Toronto, Ontario, Canada

Beatrice Setnik, PhD

VP Clinical Pharmacology, INC Research, Raleigh, North Carolina

Zoltan Harsanyi, BSc (Hon), MLS, MBA, PStat. (SSC), PSTAT® (ASA)

Director, Biostatistics and Data Management, Purdue Pharma, Pickering, Ontario, Canada.

Ken Michalko, PharmD, MBA

Retired Pharmaceutical Executive, Purdue Pharma, Pickering, Ontario, Canada

Zejiang Yang, PhD

Principal Biostatistician, INC Research, Raleigh, North Carolina

Pierre Geoffroy, MDCM, MSc, FCFP, DABAM

Physician, First Step Clinics; VP, INC Research, Toronto, Ontario, Canada.

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Published

03/01/2016

How to Cite

Sankey, MD, CCFP (EM), C., B. Setnik, PhD, Z. Harsanyi, BSc (Hon), MLS, MBA, PStat. (SSC), PSTAT® (ASA), K. Michalko, PharmD, MBA, Z. Yang, PhD, and P. Geoffroy, MDCM, MSc, FCFP, DABAM. “Opioid Use Following the Introduction of an Extended-Release Oxycodone Formulation With Tamper-Resistant Properties: Prospective Historical Chart Review in Methadone-Maintained Patients”. Journal of Opioid Management, vol. 12, no. 2, Mar. 2016, pp. 149-5, doi:10.5055/jom.2016.0327.