title: Development and impact of prescription opioid abuse deterrent formulation technologies.
abstract: BACKGROUND
  Millions of patients are treated with opioid analgesics (OpAs) to relieve pain. Unfortunately, these medications are subject to abuse and/or unintended misuse. Abuse deterrent formulations (ADFs) represent an intervention strategy to decrease abuse/misuse without affecting patient access. The Food and Drug Administration (FDA) has issued Draft Guidance "Abuse deterrent opioids, Evaluation and Labeling" and is currently actively pursuing scientific input on this issue.
  
  
  METHODS
  The development of ADF technologies was reviewed using peer reviewed journals describing OpA post marketing studies, web sites containing FDA announcements on product approvals and manufacturer product use profiles.
  
  
  RESULTS
  Reviewed is the FDA recent approval of a product label describing the abuse deterrent characteristics of OxyContin(®) (physical barrier formulation), and the FDA determination that studies were insufficient for an Opana(®) (physical barrier) ADF label. Additional reviewed marketed OpAs with ADF technologies include: Suboxone(®) and Embeda(®) (opioid agonist/antagonist combinations), Oxecta(®) (aversion technology), and Nucynta(®) (physical barrier). Reviewed ADF technologies currently in development include: new physical barrier and aversion technologies, an innovative extended release formulation as well as novel polymer-opioid conjugates. As ADF technologies are part of a comprehensive intervention strategy to promote safe OpA use, additional components including governmental, community, and educational initiatives are reviewed.
  
  
  CONCLUSIONS
  The outcomes of the recent ADF labeling applications for OxyContin(®) (Tier 3 approval) and Opana(®) (non-approval) suggest that the threshold for ADF labeling will be appropriately high. The presented findings indicate that ADF technologies can be a critical component of a comprehensive strategy to promote the safe and effective use of OpAs.
authors.affiliation: Department of Risk Management and Epidemiology, Purdue Pharma L.P., United States.
authors.forename: Louis
authors.initials: L
authors.lastname: Alexander
authors.affiliation: Department of Pharmaceutics, Purdue Pharma L.P., United States.
authors.forename: Richard O
authors.initials: RO
authors.lastname: Mannion
authors.affiliation: Department of Program Management, Purdue Pharma L.P., United States. Electronic address: brianne.weingarten@pharma.com.
authors.forename: Brianne
authors.initials: B
authors.lastname: Weingarten
authors.affiliation: Department of Regulatory Affairs, Purdue Pharma L.P., United States.
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Fanelli
authors.affiliation: Research and Development, Purdue Pharma L.P., United States.
authors.forename: Gary L
authors.initials: GL
authors.lastname: Stiles
mesh_terms: D000701:Analgesics, Opioid / Q000008:administration & dosage*; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D004348:Drug Labeling; D006801:Humans; D009293:Opioid-Related Disorders / Q000517:prevention & control*; D055553:Prescription Drugs / Q000008:administration & dosage*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000701:Analgesics, Opioid; D055553:Prescription Drugs
keywords: Abuse deterrent formulation; Non-medical use; Opioid analgesic; Pain relief; Unintended misuse