Clinical Research Society

International Society for Clinical Research and Translational Medicine

Clinical Research / Pharma News 

After Six Years FDA Finalizes Guidance on Assessing Abuse Potential of Drugs

, ,

After 6 years US FDA finalized Guidance on Assessing Abuse Potential of Drugs on 18th January 2017. The first draft was prepared almost six years back, this guidance seems to help sponsors of investigational new drugs in analyzing whether their new drug has abuse potential.42

More particularly, US FDA states that the guidance provides suggestions for evaluating the abuse potential of central nervous system (CNS)-active new drugs and whether they develop euphoria, hallucinations, and consequences consistent with CNS depressants or stimulants.

If a drug compound is CNS-active, the new drug product will probably need to go through an evaluation of its abuse potential and may be subject to control under the Controlled Substances Act.

FDA’s Controlled Substance Staff (CSS) suggests sponsors on the misuse potential evaluation of a drug, which the guidance states that is most relevant for new molecular entities with CNS activity that have not earlier been evaluated by FDA for abuse potential.

“On the other hand, if a drug compound with CNS activity is already controlled under the CSA and a various dosage form and strength, patient population, route of administration or therapeutic indication is proposed under an NDA or NDA supplement, a altered abuse potential evaluation may be essential and should be discussed with CSS,” the guidance notes.

If firms are attempting to figure out whether any particular abuse-related study should be performed, the guidance notes that a sponsor may submit abuse related questions or challenges to CDER’s Office of New Drugs (OND) review division, which will ask for a consultation from CSS.

The guidance also concentrates on when abuse-related studies must be performed (generally, FDA says after Phase II studies), preparing the NDA submission, NDA review and product labeling relevant to abuse potential, the drug scheduling process, abuse-related data from chemistry and non-clinical studies, and post marketing and illegal drug abuse data.