The Medical Letter on Drugs and Therapeutics
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1476
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Abuse-Deterrent Opioid Formulations

Development of abuse-deterrent opioid products, including reformulation of existing products, has become a priority for drug manufacturers and public health advocates. Three available opioid formulations, OxyContin (Purdue), Embeda (Pfizer), and Hysingla ER (Purdue), now include claims of abuse deterrence in their package inserts.

DETERRENCE MECHANISMS — No opioid formulation prevents consumption of a large number of intact dosage units, the most common method of abuse. Abuse-deterrent formulations have one or more properties that make their intentional nontherapeutic use more difficult, less attractive, or less rewarding; examples of such properties are listed in the table.1

LABELING REQUIREMENTS — For claims of abuse deterrence to be included in the labeling of an opioid formulation, the FDA requires that laboratory tests ... more      

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