Study shows it takes longer to develop and approve CNS drugs than non-CNS products

Developing drugs to treat central nervous system (CNS) disorders on average required 20% more time than other drugs that won marketing approval in the USA from 2000 through 2017, and took 38% longer to win that approval, according to a newly completed analysis by the Tufts Center for the Study of Drug Development. (Tufts CSDD).

"CNS drugs face greater development challenges compared to non-CNS drugs due, in large part, to a poor understanding of the underlying pathophysiology of many of the disorders they seek to treat, as well as difficulty identifying and measuring appropriate clinical endpoints," said Joseph DiMasi, director of economic analysis at Tufts CSDD.

Despite lengthier than average clinical development and approval phase times, the CNS share of new drug approvals in the USA since the 1980s has remained relatively steady, ranging from 10% to 12% on a decade-by-decade basis.