SteadyMed Therapeutics submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for Trevyent (treprostinil injection) in the treatment of pulmonary arterial hypertension (PAH), SteadyMed’s partner, Cardiome Pharma, recently announced.
Trevyent is a drug-device combination that uses SteadyMed’s PatchPump technology to deliver the vasodilatory prostacyclin analogue treprostinil. Treprostinil is a synthetic version of prostacyclin, a substance that helps prevent arteries from constricting and blood platelets from clumping together.
Trevyent is designed to improve the delivery of treprostinil through PatchPump technology, a proprietary, disposable, parenteral drug-administration platform that can be prefilled and preprogrammed to provide patients audible and visual feedback (based on sensors installed in the device) on successful delivery and end of dosing.
In June 2015, SteadyMed announced the licensing of Trevyent’s commercial rights to Cardiome in specific markets outside the United States. The licensing was dependent on approval in these international markets, and the partnership included Canada, Europe, and the Middle East.
The company now expects to file Trevyent for approval by the European Medicines Agency (EMA) and Health Canada by the end of 2017.
“The NDA filing with the FDA is an important step in the development of Trevyent and advances us closer to our goal of bringing what we believe is a better way to deliver treprostinil to patients around the world who are suffering from PAH,” Hugues Sachot, Cardiome’s chief commercial officer, said in a press release.
In January 2016, Trevyent received Orphan Drug Designation by the FDA for the treatment of PAH. Treprostinil is the only parenteral treatment for PAH that is approved by the FDA for both intravenous and subcutaneous administration.
In April of this year, a study conducted by SteadyMed concluded that the PatchPump used on Trevyent was effective, safe, and well-tolerated. The study included 60 healthy volunteers and aimed to validate Trevyent’s performance in a random patient population.
All of these advances supported the submission of Trevyent for an NDA as a treatment for PAH.