@article{ref1,
title="Development and impact of prescription opioid abuse deterrent formulation technologies",
journal="Drug and alcohol dependence",
year="2014",
author="Alexander, Louis and Mannion, Richard O. and Weingarten, Brianne and Fanelli, Richard J. and Stiles, Gary L.",
volume="138",
number="",
pages="1-6",
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 The Food and Drug Administration (FDA) has issued Draft Guidance &quot;Abuse deterrent opioids, Evaluation and Labeling&quot; and is currently actively pursuing scientific input on this issue.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.<p /> <p>Language: en</p>",
language="en",
issn="0376-8716",
doi="10.1016/j.drugalcdep.2014.02.006",
url="http://dx.doi.org/10.1016/j.drugalcdep.2014.02.006"
}