9th Annual Scientific Meeting: Developing Medicines to Treat CNS Side Effects

Co-Chairs- John Messina, PharmD; Jane Tiller, FRCPsych

CNS adverse events associated with the use of medications are common and can quite often be debilitating. These effects often prevent patients from achieving the maximum benefit from a therapy by limiting optimal dosing for efficacy and reducing the duration of use. It is unclear however, when it is appropriate to treat the side effect with an additional medication rather than either stopping the offending medication or switching to another medication that may be inferior. There is the potential to develop drugs that may eliminate or reduce the impact of CNS side effects of therapeutically important medications, but to date this potential has not been realized.

Despite the need, there are important methodological issues associated with the development of such concomitant therapies and key regulatory challenges that need to be addressed. This session is designed to highlight the key methodological and clinical challenges that are faced in the development of medications for treating the side effects of another medication. In this session speakers will discuss important issues such as defining an indication, appropriate patient selection for clinical trials, identifying appropriate outcome measures for clinical trials, and risk benefit assessment. These will be discussed from the perspective of the industry researcher, academic researcher, and the regulator.

This session will provide specific examples of medications being developed for the treatment of CNS side effects with discussion around the specific methodological questions that are raised. Representatives from Industry will provide a perspective of some of the key questions that are raised and the approaches that are needed to determine the appropriateness of initiating a clinical program as well as continuing one through the development process. Finally regulatory agency representatives from both the United States and Europe will provide their view on the appropriate approach towards pursuing such an indication.