It's no secret that neuropsychiatric diseases like schizophrenia, depression and Alzheimer's present one of the toughest challenges to drug developers. Ken Kaitin and Christopher Milne at the Tufts Center for the Study of Drug Development crunched the numbers in their database to see just how tough it is, and came up with a daunting set of figures.
Writing in Scientific American's August issue, the pair says that it takes an average of 18 years to go from the bench to the marketplace with a CNS drug, and that's for the 8.2% of therapies that survive the series of development hurdles (compared to 15% for drugs overall). Slightly less than half of the CNS drugs that make it to late-stage studies survive Phase III, compared to a 66% average. And regulatory review time takes an average of 1.9 years compared to 1.2 years.
There are some new moves that should help improve chances, including a standardized trial database and new incentives for the field from the NIH.
But add it all up and the stats illustrate why some Big Pharma companies no longer want to even try to go it alone here, according to the authors. And they say there's an inescapable conclusion: In place of individual efforts, developers, scientists and other organizations will need to create networks to push new CNS drugs through to approval.
- here's the analysis in Scientific American from Tufts