New delivery system for treatment of pulmonary arterial hypertension is safe, accurate

A new delivery system currently in development for the treatment of pulmonary arterial hypertension—treprostinil and PatchPump prefilled, disposable infusion system (Trevyent)—is safe, and provides not only dosing accuracy and precision, but tolerability for on-body application of the product.

These results have kept this combo drug/delivery system on track for a New Drug Application submission during the second quarter of 2017.

Treprostinil is a stable, long-acting prostacyclin analogue that can be administered as a continuous subcutaneous infusion with a portable miniature delivery system. To establish the safety and efficacy of the PatchPump device designed to accomplish this, researchers enrolled 60 healthy adult volunteers for the clinical validation of treprostinil and PatchPump. Each subject was administered one PatchPump device, which contained a placebo formulation to be used for 48 hours.

The PatchPump is a customizable, pre-filled, pre-programmed disposable parenteral delivery platform for large volume and viscous formulations. It is powered via ECell technology, which is a unique, small, self-powered expanding battery that is fully disposable, electronically controlled to enable accurate dosing, and expands under high pressures to enable delivery of viscous drugs.

Researchers found that the PatchPump device was safe, and performed well in delivering accurate and precision dosing. Patients were also highly tolerant of the device.  

“We are delighted to announce the completion of this important study for Trevyent. This milestone brings us one step closer to the planned submission of the Trevyent NDA, which remains on track for the second quarter. We believe that the completion of this study, with units performing exactly as intended, confirms the utility of Trevyent over its intended 48-hour duration of single-unit use," said Jonathan MN Rigby, President and CEO of SteadyMed Therapeutics, Inc. of San Ramon, CA. “Trevyent is a highly differentiated product that has been specifically designed to address clear unmet needs in the PAH community and we look forward to bringing Trevyent to patients suffering from PAH, if approved by the FDA, in 2018."