Part 1: A Review of 2019 Product Approvals
Part 2: Notable Drug Delivery and Formulation Product Approvals of 2019
Part 3: Notable Drug Delivery and Formulation Transactions and Technologies of 2019
Part 4: The Drug Delivery and Formulation Pipeline

By: Josef Bossart, PhD, Executive Editor, PharmaCircle LLC

Introduction
This is the fourth edition of the report’s Notable Drug Delivery and Formulation Product Approvals, and the most challenging from an editorial perspective. In previous years, it was possible to identify 10, 20, or even 30 approvals that reflected a new or existing drug delivery technology in new or clinically important ways. That wasn’t the case for 2019. While many products were approved using a variety of drug delivery and formulation technologies, very few qualified as notable. This year, we have decided to limit this section to four approvals.

Perhaps drug delivery has just been in a resting phase in terms of technology and novel product development for the past decade. Technology in general is marked with leaps and rests. When was the last time you really needed the technology benefits offered by a new computer, television, or microwave oven? The auto industry seems to be breaking out of a decades-long technology rest with self-driving and electric vehicles. Auto styles and colors may change annually, but for decades we were off ered the same vehicles with a new design and a few more creature comforts. It seems to be the same with drug delivery technologies. What worked in 1985 still works in 2020, perhaps with somewhat better performance, but little else. The most exciting potential drug delivery technology of the past two decades, inhaled macromolecules, has largely failed and been supplanted by patient-friendly autoinjectors. Better, but not really notable in 2019.

The four selected products, using technologies developed as much as decades ago, provide insight into the future of therapeutics and business. Zolgensma, Novartis’ gene therapy for the treatment spinal muscular atrophy is perhaps the first significant step in validating gene delivery and expression as a viable therapeutic option for simple genetic diseases. Janssen’s Spravato is notable less for the nasal delivery technology than the elegance of its solution to a pressing medical need. Rybelsus, the first non-injectable macromolecule likely to achieve widespread use and commercial success may also close the door behind it, at least with this generation of macromolecule absorption enhancers. What’s next? Aurora’s High CBD Drops points to a parallel future when the increasing sophistication of botanicals competes directly with more traditional pharmaceutical products.

Is there a technology revolution sitting on a lab bench or in the clinic? That will be subject of the next two parts of this report. Let’s appreciate for now what 2019 has delivered. Click here to download/view part 2 of the entire report.