Drug and alcohol dependence
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Drug Alcohol Depend · May 2014
ReviewDevelopment and impact of prescription opioid abuse deterrent formulation technologies.
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 The Food and Drug Administration (FDA) has issued Draft Guidance "Abuse deterrent opioids, Evaluation and Labeling" and is currently actively pursuing scientific input on this issue. ⋯ 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.