Drug Abuse Potential

The FDAs guidance for NDAs includes sections on Drug Abuse Potential if the drug is a CNS penetrant or shows CNS activity.

The content of the drug abuse potential section of an NDA typically includes (or cross-references) complete study protocols and all primary abuse-related data from the following:

1. Chemistry studies

2. Receptor-ligand binding studies and functional (second messenger) studies

3. Pharmacokinetic studies in animals and humans

4. Abuse–related studies in animals: a) General behavioral observations from safety pharmacology studies b) Drug discrimination study c) Self-administration study d) Physical dependence study

5. Abuse-related studies in humans: a) Human abuse potential (HAP) study b) Physical dependence study

6. Abuse-related AEs from clinical studies

7. Information related to overdose, both intentional and accidental, during clinical studies

8. Assessment of the incidence of abuse during clinical studies

(source Assessment of Abuse Potential of Drugs Guidance for Industry page 8).

 

As part of the “Chemical Studies”, Scitegrity can quickly and cost effectively produce a Drug Abuse Potential, Chemical Similarity assessment to Schedules 1 to 5 controlled drugs within the United States of America.

Using its extensive database of controlled substances and algorithms to search controlled chemical space, combined with industry leading tools, we remove the subjective nature of assessing whether something is chemically ‘similar’ to known controlled substances, with data rather than opinion.

These assessments can also be carried out earlier in the development cascade on larger numbers of compounds as part of de-risking efforts 

 

“As part of Catalyst efforts to develop a new CNS drug, Scitegrity performed a quantitative chemical similarity test between our drug an all schedule I through V controlled substances.  In a matter of weeks, Scitegrity completed this work and prepared a report suitable for NDA submission and review by the FDA’s controlled substances staff.  In addition, the speed and high quality, it was conducted with minimal oversight and interaction with Scitegrity.  It is nice to have a contractor that just gets things done right and leaves one less thing to worry about during the drug development process.” - Steven Miller, Chief Scientific Officer, Catalyst Pharmaceuticals

 

Scitegrity is delighted to report that on the 28th of November 2018, the FDA approved Catalyst Pharmaceuticals Firdapse (amifampridine), the drug referred to by Steven above, for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.

 

E-mail us more information, or sign up for our newsletters on Controlled Substance Compliance and Drug Abuse Potential

 

 

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