Being focused on specific dosage forms such as transdermal patches and mucosal thin films allows ARx to understand the trends in development and commercial markets. We are uniquely positioned to understand what makes a thin film or transdermal product successful and the importance of selecting the right active pharmaceutical ingredients and applications for the dosage form.
A recent PharmaCircle report available on page 25 of the June 2019 edition of Drug Development & Delivery highlighted the Approved Drug Products between 2014 and 2019 in comparison to Pipeline Products in Phase III or Registration Stage in major markets by administration route. Buccal and sublingual products showed a lower percentage in development than approved, and the transdermal route of administration was included in the “all other” category.
PharmaCircle highlighted the low buccal/sublingual pipeline activity as being due in part to the consequence of the relatively poor commercial success of earlier products. While PharmaCircle is correct with their observations, ARx’s development pipeline from pre-clinical to Phase I/II of mucosal thin film products is stronger than ever. More pharmaceutical companies realize the rapid onset, reduction of adverse events associated with the first-pass metabolism, and more consistent pK profile benefits of the dosage form compared to oral tablets/capsules and injections that may experience issues in development. More specifically, interest is high among central nervous system indications. As companies realize how patients can truly benefit from a sublingual or buccal film beyond convenience, the commercial success of products will grow significantly over the next 5-10 years. ARx is also happy to report that the same trend is noted in the development of transdermal patches. The benefits of transdermal patches, such as less adverse events from a controlled-release profile and avoidance of the first-pass metabolism, are more commonly known than mucosal thin films.
It is no secret that many transdermal products have not been approved in the last few years, with the last one being ZTlido™ (1.8%) from Scilex Pharma on Feb 28, 2018. Exciting news also came late 2018 with an announcement from Noven Pharmaceuticals that a New Drug Application was submitted for an asenapine transdermal patch system for treatment of schizophrenia. Despite the small late stage transdermal pipeline, ARx has recently engaged in some promising transdermal products in the early phases of development that have the potential to overcome the shortcomings associated with the actives in a tablet or capsule and reinvigorate the transdermal patch market.
“2018 Global Drug Delivery & Formulation Report: Part 4, The Drug Delivery & Formulation Pipeline”, Kurt Sedo, VP of Operations, and Tugrul Kararli, PhD, President & Founder, PharmaCircle