FDA Issues Guidance for Evaluating Abuse Potential of Drugs

The FDA has finalized guidance designed to help investigational drug sponsors determine whether a new product can be potentially abused. The 37-page guidance offers recommendations for sponsors looking to assess whether central nervous system (CNS)-active drugs hold the potential for abuse and whether they can produce adverse effects, such as euphoria and hallucinations.

“Drug products that are determined to have abuse potential may contain substances that are chemically or pharmacologically similar to other controlled substances, or they may have novel chemical structures and/or mechanisms of action in the brain,” the FDA stated in its guidance.

In the event that a product initiates these adverse effects, it may need to undergo a test to pinpoint its abuse potential, and it could be subject to scheduling under the Controlled Substances Act.

The Controlled Substance Staff (CSS) of the FDA’s Center for Drug Evaluation and Research’s Office of the Center Director works to advise sponsors on the abuse potential testing of drugs. The FDA also notes that if a drug with CNS activity is already controlled under the Controlled Substances Act and it is a part of a new drug application, it may need a new abuse potential assessment.

Drug sponsors who have questions about the new guidance can send their concerns to the CDER’s Office of New Drugs review division, which will ask for consultation from the CSS.