Obtaining FDA Approval For CNS Drugs Remains Industry Challenge, Study Finds

Tufts Center for the Study of Drug Development released a report, detailing their findings about the long and bumpy road central nervous system (CNS) drugs experience from discovery to FDA approval. Historically, these drugs are challenging to fully develop, and Tufts recent data only reaffirms that gaining FDA approvals for CNS drugs is no mean feat.

Failure rates throughout the clinical trial phases for CNS drugs are significantly higher. In those rare cases when a drug succeeds through all three phases, chances for approval are slimmer.

Tufts research found that the likelihood for FDA approval for CNS drugs was roughly half of that reported for other drugs (6.2 percent versus 13.3 percent). Furthermore, it takes the agency longer on average to make a decision on CNS drugs, though Tufts reported the margin of difference has reduced in recent years.

CNS disease covers a broad spectrum of conditions ranging from depression to Alzheimer’s. Not only are these diseases chronic, they also present a unique set of concerns as they move through the clinical trial process. Results and progress often have no quantifiable measure and depend almost solely on patient reports and behavior.

In 2012, the FDA released guidance for developing CNS drugs, which required additional evaluation of suicidal thoughts and actions that can occur in conjunction with CNS drugs. RAPS posits that these additional concerns might also be slowing the approval process.

A complicated disease requires a complicated drug, and researchers are still unwinding the secrets of the central nervous system. CNS drugs do exist on the market, but in many cases, scientists do not understand precisely why they work.

President Obama signed The National Alzheimer’s Project Act (NAPA) in 2011 which set ambitious goals for Alzheimer’s research, discovery, and development. Though research is not progressing as quickly as researchers would like, there has been substantial inroads into the precise pathology of the disease.

Still, progress is slow. Pharmaceutical Research and Manufacturers of America (PhRMA) reports that for every one clinical study that yields a new medicine for Alzheimer’s, 34 fail to reach their endpoint.