Identification of potential for abuse in any medicinal product involves its classification and scheduling, and seriously influences development, the prescribing practice, and market access.
Most importantly, assessment of potential for abuse in any brain penetrant drug is now a regulatory requirement for progression to the conclusive stages of development and final market authorisation.
Although clear guidelines have been published by the major regulatory agencies for selected classes of compounds, a flexible case-to-case investigational approach, specific for the type of active substance or underlying mode of action, is strongly recommended.