Treprostinil is a vasodilatory prostacyclin analogue, or synthetic version of prostacyclin, a substance that helps prevent arteries from constricting and blood platelets from clumping together. Prostacyclin is deficient in some patients with severe PAH, studies have shown.
SteadyMed’s PatchPump disposable infusion system is what its name implies: a pump in a patch. The pump is pre-filled with treprostinil and preprogrammed at the correct delivery rate. The single-use PatchPump has sensors that provide audible and visual feedback on successful delivery and end of dosing.
The study covered 60 healthy volunteers at a clinic. The goal was to validate Trevyent’s performance in a patient population.
Each participant received a PatchPump containing a placebo that patients used for 48 hours while continuing their daily life.
The primary objectives of the study were assessing the performance and safety of PatchPump as a delivery system. Patients’ ability to tolerate an on-body application device was also assessed.
The technology performed as intended in all categories of evaluation, SteadyMed said.
“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 [New Drug Application], 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,” Jonathan M.N. Rigby, president and chief executive officer of SteadyMed, said in a press release.
“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,” he added.
SteadyMed remains on track to submit a New Drug Application for Trevyent as a PAH treatment. It expects to provide the application to the U.S. Federal Drug Administration in the second quarter of this year.
The company is also preparing for the commercialization of Trevyent in the United State. It has already signed an exclusive licensing and supply agreement with Cardiome Pharma to commercialize Trevyent in Europe, Canada and the Middle East, Pulmonary Hypertension News reported earlier.
In the meantime, SteadyMed and United Therapeutics continue to dispute a patent over the purification of prostacyclin derivatives such as treprostinil.
Treprostinil is the only therapy the FDA has approved as an intravenous or injected treatment for PAH. Trevyent is still an investigational drug product, however, so it has yet to be approved.