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Drugs that treat central nervous system diseases take more than a year longer to develop
Drugs that treat central nervous system (CNS) diseases take more than a year longer to develop and are less than half as likely to obtain marketing approval than other drugs, according to a newly completed study by the Tufts Center for the Study of Drug Development.
Mean clinical development time for CNS drugs approved for marketing in the United States from 1999 through 2013 was 12.8 months, or 18%, longer than for non-CNS compounds, according to Tufts CSDD.
In addition, the overall clinical approval success rate (share of compounds entering clinical testing that obtain marketing approval) for CNS compounds first tested in human subjects from 1995 to 2007 (and followed through 2013) was 6.2%, or less than half the 13.3% rate for non-CNS drugs.
"CNS drugs are more challenging to develop than other medicines, because the conditions they aim to treat are typically chronic and complex, and clinical endpoints are often difficult to measure," said Joseph A. DiMasi, director of economic analysis at Tufts CSDD and author of the study. "That's why CNS drug development takes longer and has a lower likelihood of overall clinical success than non-CNS drug development."
CNS drugs treat a wide array of psychiatric and neurodegenerative disorders, including depression, psychosis, epilepsy, and Alzheimer's disease.
The success rate analysis was based on development and approval histories of 274 CNS and 1,168 non-CNS investigational compounds, and the approval phase time analysis was based on 42 CNS and 345 non-CNS therapeutic compounds approved by the U.S. Food and Drug Administration (FDA).
Other findings from the study, reported in the November/December Tufts CSDD Impact Report, released today, include the following: