The Death of CNS Drug Development

Over the past year, several major pharmaceutical companies have scaled back or abandoned their neuropsychiatric drug development efforts, citing high costs and long development times with low success rates. A report from the Tufts Center for the Study of Drug Development reveals that only 8.2% of CNS drug candidates reach clinical use, compared to 15% of other drugs. Regulatory approval for CNS drugs takes about 1.9 years, nearly a year longer than for non-CNS drugs. Additionally, Phase II and III development for CNS drugs averages 8.1 years—more than two years longer than for other therapeutic areas—often leading to delayed trials and high costs. With only 46% of CNS drugs succeeding in Phase III trials, compared to 66% for other drugs, the financial and resource demands make CNS drug development one of the most costly and risky areas in pharmaceuticals.