Impacts of drinking-age legislation on arrests for alcohol-impaired driving among young people in Canada, 2009–2012

Abstract

Aims: Provide an overview of FDA’s evaluation of novel abuse deterrent (AD) opioid products. Methods: Abuse and misuse of opioid drug products is a public health concern. One approach for managing the problem is reformulation of the products tomake them safer and less euphorigenic. Current efforts focus primarily on making the products more difficult to “manipulate” for injection, insufflation and inhalation. The development, assessment, and regulation of AD formulations of opioid products that are less prone to abuse or misuse is a policy priority. The FDA Center for Drug Evaluation and Research developed guidance to evaluate and label ADopioid formulations (2013), and held public meetings. Results: Premarket assessment of AD products involves three categories of studies. The first category consists of in-vitro manipulation and extraction studies to evaluate whether the AD features of a new formulation can be compromised under experimental conditions. Pharmacokinetic (PK)/pharmacodynamic (PD) studies (second category) are designed tounderstand the in vivoproperties of the new formulation by comparing the PK profiles of the “manipulated” formulationwith the intact formulation and other drugs by one or more routes of administration, and to collect PD data such as adverse events due to administration of themanipulated formulation. In the third category, the relative abuse potential of the AD formulation (intact and manipulated) is studied in human abuse potential studies. Results of the premarket assessment are used for labeling. As FDA gains experience in the evaluation of AD products, questions arise regarding science-based approaches to appropriately characterize the deterrent properties and to support labeling of the products. Conclusions: Abuse-deterrent technologies and evaluation methodology are rapidly changing. FDA recognizes the need to identify the best approaches to characterize these products to support labeling. Financial support: N/A.