Does every CNS drug-candidate require a program of GLP non-clinical abuse potential testing?
The short answer to the question is “No”. Although the FDA and EMA will evaluate the abuse and/or dependence potential of all CNS drug-candidates, in some cases they can perform that evaluation without data from GLP non-clinical abuse/dependence tests. A couple of weeks ago, one of our European pharma clients received notification from the FDA granting it a waiver on all non-clinical GLP abuse/dependence testing by the CSS for its CNS
drug-candidate. The waiver was given based on a scientific case that DevelRx had prepared, and it is the fourth waiver that we have managed to secure from the FDA.
The scientific assessment we prepared was based on information from multiple sources that provided a solid evidence base to support our client’s proposal for an abuse/dependence GLP testing waiver.
If you believe that your company’s drug-candidate has a good case for a waiver on GLP abuse/dependence testing, or would like us to give you an expert opinion on this question, contact inform@develrx.com