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Is There Support for Abuse-Deterrent and Tamper-Resistant Opioid Formulations?
Robert N. Jamison
The Journal of Pain, Volume 14, Issue 4, April 2013, p359-360
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. 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. 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. 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.