SteadyMed (NSDQ:STDY) said yesterday that it finished a clinical study for its lead drug candidate, Trevyent. The pulmonary arterial hypertension treatment is a combination of treprostinil and the PatchPump prefilled, disposable infusion system.
The San Ramon, Calif.-based company said it is on track to submit a New Drug Application for Trevyent in the 2nd quarter of 2017.
The trial enrolled 60 healthy adults and each participant was given 1 PatchPump device with a placebo formulation to be used for 48 hours. The study’s objective was to evaluate safety and performance functions of Trevyent’s delivery system, including dose accuracy, precision, and tolerability for on-body application, the company said.
SteadyMed reported that the PatchPump devices performed “as intended in all categories of evaluation.”
“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,” president & CEO Jonathan Rigby said in prepared remarks. “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.”
“We continue to be pleased with the progress of our partnership with SteadyMed,” Cardiome’s senior VP of commercial biz, Hugues Sachot, said. “We licensed Trevyent because we believed that there was a better way to deliver treprostinil to patients suffering from Pulmonary Arterial Hypertension, and we remain convinced that Trevyent will provide just that.”