Strategic Considerations for a Successful CNS Clinical Development Pathway

Central Nervous System (CNS) drug evaluation requires the assessment of specific safety endpoints, such as the drug’s potential to cause impairing effects on driving, the likelihood that it may be abused or misused, or the risk of causing withdrawal symptoms if abruptly discontinued. Evaluation of CNS effects in  Phase I studies can be very helpful in determining if dedicated driving simulator, abuse potential, and dependence studies are needed. Furthermore, including drug effect evaluations and measures of cognition in early studies enables better pharmacological characterization since larger dose ranges are studied. Methods for determining the need for additional studies will enable developers to accurately project their clinical development timeline and have more informed discussions with regulatory agencies.