This guidance should help sponsors of investigational new drugs and new drugs for approval evaluate whether their new drug product has abuse potential.
How to evaluate the abuse potential of central nervous system (CNS)-active drugs and recommendations for assessing whether drugs produce mood changes, hallucination, and effects consistent with CNS depressants or stimulants are covered in the guidance. It also includes the key decision points in an abuse potential assessment, the kinds of abuse-related studies that may be important, when to conduct such studies (usually after phase II studies), the organisation of abuse-related information in an NDA submission and product labelling.
Evaluation of abuse potential is most relevant for new molecular entities with CNS activity that have not previously been assessed by FDA for abuse potential. However, if a drug substance with CNS activity is already controlled under the Controlled Substances Act and a different dosage strength, dosage form, route of administration, patient population, or therapeutic indication is proposed under an NDA or NDA supplement, a modified abuse potential assessment may be necessary and should be discussed with Controlled Substance Staff at CDER.
FDA notes that “post-marketing data may provide information regarding whether the drug substance produces abuse-related signals and potential risks. Similarly, if a drug substance in the new drug product has been used for abuse purposes, information may be available regarding the rewarding effects and safety issues associated with the drug substance.” However, such data will not be an acceptable replacement for a robust abuse potential assessment conducted prior to submission of an NDA.
Please click here to access the guidance.