Overview: Abuse Deterrent Formulations

Although opioids remain an important tool in aiding the management of pain in the United States, the balance between the potential benefits and harms must be considered. Some specific harms are manifested in the abuse of opioids for nonmedical purposes. The primary access to prescribable opioids for abuse is through illegal diversion. Those abusing opioids may do so through a variety of mechanisms, including taking excessive doses, altering formulations, and changing the route of delivery. For example, an oral formulation may be modified and abused through nasal snorting or intravenous injection. The FDA has developed guidelines for a clinical study design for "abuse deterrent opioids" and has labeled a number of opioids with language that they are "abuse deterrent." This session will review the FDA's publication "Abuse Deterrent Opioids-Evaluation and Labeling: Guidance for Industry" as well as discuss many of the novel technologies developed and labeled specifically to minimize the likelihood of abuse, while retaining the potential benefits of opioids in the management of pain. (Recorded at PAINWeek 2016)