Therapeutic transdermal drug innovation from 2000 to 2014: current status and outlook

The US Food and Drug Administration (FDA) approved the first transdermal drug over 35 years ago. Today, transdermal products represent a growing, multibillion dollar market. From 2000 to 2014, an average of 2.6 new transdermal drug were approved each year. However, only two of these approvals represented new molecular entities (NMEs). Furthermore, none of these approvals were designated for priority review by the FDA. Currently, transdermal drugs are limited in scope to fewer than 20 clinical indications. The past decade has seen significant safety, performance, and cost issues surrounding multiple transdermal drug products. As the field moves towards more complex drug-device combinations to overcome the natural barrier function of the skin, there will likely be more regulatory challenges, but also the potential for broader clinical scope.