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Evaluation of Abuse Deterrent Formulations
Abuse deterrent Opioid analgesics are intended to minimize abuse and diversion while providing effective pain control for appropriate patients.  Measuring and balancing these considerations are important challenges for the US Food and Drug Administration (FDA).  Methods and criteria for a sponsor to achieve demonstrated abuse deterrence are needed, but have not been established.  Allowing a label claim or statement regarding abuse deterrence will provide a competitive advantage to a new product.  However, abuse is difficult to study because many of the behaviors that need to be measured are illegal, heavily stigmatized and concealed.  Furthermore, experience has shown that abuse detected by post marketing surveillance is different and more widespread than suggested by preapproval studies.