Is There Support for Abuse-Deterrent and Tamper-Resistant Opioid Formulations?

Abstract

Recent attention has been given to the development of abuse-deterrent and tamper-resistant opioid formulations in light of concern over the epidemic misuse of opioids prescribed for the treatment of chronic pain. 6 Okie S. A flood of opioids, a rising tide of deaths. N Engl J Med. 2010; 363: 1981-1985 Crossref PubMed Scopus (689) Google Scholar , 7 Schneider J.P. Matthews M. Jamison R.N. Abuse-deterrent and tamper-resistant opioid formulations: What is their role in addressing prescription opioid abuse?. CNS Drugs. 2010; 24: 805-810 Crossref PubMed Scopus (52) Google Scholar Statistics provided by the Centers for Disease Control and Prevention have demonstrated a 4-fold increase in opioid-related overdose deaths over the past decade in response to the increased availability of prescription opioid analgesics. 2 Centers for Disease Control and Prevention (CDC)Vital signs: Overdoses of prescription opioid pain relievers–United States, 1999-2008. Morb Mortal Wkly Rep. 2012; 60: 1-6 Google Scholar The Food and Drug Administration (FDA) has specifically targeted the abuse of extended-release (ER) and long-acting (LA) opioid formulas by issuing a call for Risk Evaluation and Mitigation Strategies (REMS) designed to reduce opioid abuse and misuse. 4 Food and Drug Administration: Extended-release (ER) and long-acting (LA) opioid analgesics risk evaluation and mitigation strategy (REMS). Reference ID: 3154773. Approved 7/2012. Accessed on August 6, 2012. http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM311290.pdf Google Scholar Ever since the original Oxycontin (OC) was approved by the FDA in 1995 and subsequently found to have a high potential for abuse, multiple pharmaceutical companies have been targeting the development of controlled-release opioid products that are resistant to abuse by physical (chewing, crushing, grinding) or chemical (extracting) manipulation. However, despite the introduction of many reformulated opioid products, there has been reluctance by the FDA to approve a change in the labeling of these oral opioid products because of lack of epidemiological evidence that they do what they were intended to do and fear that these products will contribute to further abuse. Abuse Rates and Routes of Administration of Reformulated Extended-Release Oxycodone: Initial Findings From a Sentinel Surveillance Sample of Individuals Assessed for Substance Abuse TreatmentThe Journal of PainVol. 14Issue 4PreviewOxycodone 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. Full-Text PDF