Central nervous system (CNS) studies are the second highest therapeutic area for participant recruiting in clinical trials when COVID-19 related trials are excluded1 .
Yet, the number of trials being conducted in CNS is dwarfed by the trials in progress for oncology: 47% oncology and 13% CNS2 . This may correlate to some of the challenges present in designing, executing, and achieving regulatory approval for new CNS treatments.
For example, in 2021, the FDA completed 50 Novel Drug Approvals (NDAs), none of which were for a major psychiatric disease. Three were for neurological degenerative disorders, two were for opioid dependency, and one was for migraines.
CNS is a highly complex and diverse therapeutic area with many different diseases falling into this category. CNS drugs face greater development challenges compared to non-CNS drugs, in part due to poor understanding of the underlying causes and factors contributing to the diseases, and complicated by the lack of appropriate endpoints to measure effectiveness. Clinical trials in CNS tend to take longer to complete and on average take 38% longer to gain approval by the FDA3 .