FDA Issues Draft Guidance on Drugs with Potential for Abuse

The US Food and Drug Administration issued a draft guidance for industry, Assessment of Abuse Potential of Drugs, in late January. The document is meant to assist manufactures developing drug products that have the potential to be abused, as defined by the Controlled Substances Act (21 USC 811b-c).

These types of drugs typically affect the central nervous system, are chemically or pharmacologically similar to other drugs with known abuse potential, or produce psychoactive effects such as sedation, euphoria, or mood change, said the guidance.

The document includes a definition for “abuse potential” and provides information on what to include in abuse-potential assessments, including a proposal for scheduling and study design. Such assessments must be provided to FDA with the sponsor’s new drug application (NDA) for any drug product that has abuse potential.

Information to be submitted with the NDA, according to the draft guidance, includes a summary, interpretation, and discussion of abuse-potential data provided in the NDA; a proposal and rationale for placing (or not placing) a drug into a particular schedule of the Controlled Substances Act; all primary data related to the abuse-potential characterization of the drug, organized under chemistry, preclinical pharmacology, animal behavioral and dependence pharmacology, pharmacokinetics−pharmacodynamics, human abuse potential laboratory studies, clinical-trial data relative to abuse and dependence potential, integrated summaries of safety and efficacy, and foreign experience with the drug.