The US FDA Draft Guidance for Developing Abuse-Deterrent Opioid Analgesics: 2014 and Beyond

Abstract

Prescription medication abuse, particularly of opioids, remains a serious public health problem. Many socioeconomic and healthcare system factors have contributed to the resulting epidemic of prescription opioid abuse. As the scope of this epidemic became evident, efforts to make abuse-deterrent formulations (ADFs) began, and many ADFs are under development. In January 2013, the US Food and Drug Administration (FDA) issued a Draft Guidance outlining the categories of studies needed for evaluating the abuse-deterrent properties of ADF opioids (e.g., pre-market in vitro, pharmacokinetic and abuse potential studies, and post-marketing studies) and the four potential label claims that might be made about the products. Studies to be conducted are those required for approval, those that might be included as data in the label (implicit claims), and those that would be required to merit a specific explicit claim—Tier 1, 2, 3, or 4. In the context of the Guidance, new ADFs need to consider the unique features of their technology, market size, comparator products, actual routes and methods of abuse, the targeted health consequences of abuse, pricing and reimbursement, the impact of other interventions to decrease abuse, and the challenges in doing post-market studies. ADFs will not stop prescription opioid drug abuse; however, easily tampered formulations should not contribute to the problem. All extended-release (ER) opioids and other abusable drugs should have abuse-deterrent properties. Immediate-release (IR) opioids should also be formulated with abuse-deterrent properties, because abuse of IR opioids is a more common and serious problem than that of ER opioids. Maximum dosage strengths of ER opioids should also be limited. Finally, the current situation, where non-abuse-deterrent ER opioids exist concurrently on the market is extremely problematic from a public health policy perspective.