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Study shows CNS drugs take longer than others to develop, receive approval
The time from investigational new drug application filing to NDA/BLA approval by FDA of drugs for central nervous system disorders and the subsequent regulatory approval can take 35% longer than other therapeutic categories, according to a recent analysis published in the March/April Tufts Center for the Study of Drug Development Impact Report.
The time from investigational new drug application filing to NDA/BLA approval by FDA of drugs for central nervous system (CNS) disorders and the subsequent regulatory approval can take 35% longer than other therapeutic categories, according to a recent analysis published in the March/April Tufts Center for the Study of Drug Development Impact Report.
“Although I expected that CNS drug development and approval times were longer than average, I was somewhat surprised at the extent to which they were longer,” said Joseph A. DiMasi, PhD, director of economic analysis, Tufts Center for the Study of Drug Development (CSDD), and principal investigator. “I also found it surprising that non-CNS drugs were two-and-one half times more likely to receive a priority review rating from the FDA than were CNS drugs.”
Dr DiMasi and colleagues analyzed data from FDA and Tufts CSDD databases of approved and investigational drugs. To assess clinical approval success rates and clinical phase transition rates for CNS drugs and biologics, the researchers obtained data for the top 50 pharmaceutical firms in 2006 on self-originated investigational drugs and biologics first tested in humans between 1994 and 2007.
During a 15-year period spanning 1996 to 2010, the investigators found that the mean clinical phase plus approval time for CNS drugs was 32 months longer than that for non-CNS drugs. The mean time for CNS drugs to complete the clinical trial process was 102.2 months, which equates to 40% longer than non-CNS drugs. The mean approval time for CNS drugs during that same time period was then 20.3 months, which equates to 13% longer than the non-CNS counterparts.
CNS drugs with standard review ratings took a mean 28 months longer than non-CNS drugs to get through the clinical-plus-approval phase, while CNS drugs with priority review ratings took a mean 56 months longer than non-CNS drugs.
The CNS new product pipeline is the richest among therapeutic categories, growing 6% annually over the past decade to account for 11% of current drug development projects, Dr DiMasi and colleagues noted. However, they found that the estimated clinical approval success rate for self-originated CNS drugs entering clinical trials between 1993 and 2004 was about 1 in 10, compared to 1 in 6 for all self-originated drugs.
“Given the high risks and lengthy development times for drugs often intended to treat serious conditions that affect many people, it is imperative that developers, regulators, and academics find ways to improve productivity and shorten time to market for compounds that can make significant contributions in this therapeutic area,” Dr DiMasi said.
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
June 30th 2014The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).
Management of antipsychotic medication polypharmacy
June 13th 2013Within our healthcare-driven society, the increase in the identification and diagnosis of mental illnesses has led to a proportional increase in the prescribing of psychotropic medications. The prevalence of mental illnesses and subsequent treatment approaches may employ monotherapy as first-line treatment, but in many cases the use of combination of therapy can occur, leading to polypharmacy.1 Polypharmacy can be defined in several ways but it generally recognized as the use of multiple medications by one patient and the most common definition is the concurrent use of five more medications. The presence of polyharmacy has the potential to contribute to non-compliance, drug-drug interactions, medication errors, adverse events, or poor quality of life.
Medical innovation improves outcomes
June 12th 2013I have been diagnosed with stage 4 cancer of the pancreas, a disease that’s long been considered not just incurable, but almost impossible to treat-a recalcitrant disease that some practitioners feel has given oncology a bad name. I was told my life would be measured in weeks.
