A guidance finalized on Wednesday, almost six years after it was first drafted, looks to help sponsors of investigational new drugs in evaluating whether their new drug product has abuse potential.
More specifically, the US Food and Drug Administration (FDA) says the 37-page guidance offers recommendations for assessing the abuse potential of central nervous system (CNS)-active new drugs and whether they produce euphoria (or other changes in mood), hallucinations, and effects consistent with CNS depressants or stimulants.
If a drug substance is CNS-active, the new drug product will likely need to undergo an assessment of its abuse potential and may be subject to control under the Controlled Substances Act.
The Controlled Substance Staff (CSS) of FDA's Center for Drug Evaluation and Research's Office of the Center Director advises sponsors on the abuse potential assessment of a drug, which the guidance says 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 CSA and a different dosage strength, dosage form, route of administration, patient population, or therapeutic indication is proposed under an NDA [new drug application] or NDA supplement, a modified abuse potential assessment may be necessary and should be discussed with CSS," the guidance notes.
If companies are trying to determine whether any specific abuse-related study should be conducted, the guidance notes that a sponsor may submit abuse-related questions or issues to CDER's Office of New Drugs (OND) review division, which will request a consultation from CSS.
The guidance also focuses on when abuse-related studies should be conducted (in general, FDA says after Phase II studies), preparing the NDA submission, NDA review and product labeling related to abuse potential, the drug scheduling process, abuse-related data from chemistry and nonclinical studies, and post-marketing and illicit drug abuse data.
Assessment of Abuse Potential of Drugs: Guidance for Industry