Appropriate experimental approaches for predicting abuse potential and addictive qualities in preclinical drug discovery.

ABSTRACT

INTRODUCTION: Drug abuse is an increasing social and public health issue, putting the onus on drug developers and regulatory agencies to ensure that the abuse potential of novel drugs is adequately assessed prior to product launch. AREAS COVERED This review summarizes the core preclinical data that frequently contribute to building an understanding of abuse potential for a new molecular entity, in addition to highlighting models that can provide increased resolution regarding the level of risk. Second, an important distinction between abuse potential and addiction potential is drawn, with comments on how preclinical models can inform on each. EXPERT OPINION While the currently adopted preclinical models possess strong predictive validity, there are areas for future refinement and research. These areas include a more refined use of self-administration models to assess relative reinforcement; and the need for open innovation in pursuing improvements. There is also the need for careful scientifically driven application of models rather than a standardization of methodologies, and the need to explore the opportunities that may exist for enhancing the value of physical dependence and withdrawal studies by focusing on withdrawal-induced drug seeking, rather than broad symptomology.