SteadyMed Ltd. recently announced the successful completion of a clinical study for its lead drug product candidate, Trevyent. Trevyent is a combination of the company’s treprostinil and PatchPump prefilled, disposable infusion system that is in development for the treatment of Pulmonary Arterial Hypertension (PAH). The company remains on track for a New Drug Application (NDA) submission for Trevyent to treat PAH, in the second quarter of 2017.
This study enrolled 60 healthy adult volunteers in an in-clinic setting, and was intended to provide clinical validation of the performance of the Trevyent product. Each subject was administered one PatchPump device containing a placebo formulation, to be used for 48 hours while subjects otherwise carried on with normal daily and nighttime activities. The objective of the study was to evaluate the essential safety and performance functions of Trevyent’s proprietary delivery system, including dose accuracy and precision, as well as tolerability for on-body application of the product. The results indicate 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," said Jonathan M.N. Rigby, President and CEO of SteadyMed. “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."
SteadyMed Ltd. is a specialty pharmaceutical company focused on the development of drug products to treat orphan and high-value diseases with unmet parenteral delivery needs. The company's lead drug product candidate is Trevyent, a development stage drug product that combines SteadyMed's PatchPump technology with treprostinil, a vasodilatory prostacyclin analogue to treat pulmonary arterial hypertension (PAH). SteadyMed intends to commercialize Trevyent in the US and has signed an exclusive license and supply agreement with Cardiome Pharma Corp. for the commercialization of Trevyent in Europe, Canada, and the Middle East. SteadyMed has offices in San Ramon, California and Rehovot, Israel. For more information, visit www.steadymed.com.