Trevyent®, a new treatment system that utilizes subcutaneous delivery of treprostinil for pulmonary arterial hypertension (PAH) patients, was submitted to the U.S. Food & Drug Administration (FDA) for approval. The FDA received a New Drug Application (NDA) by United Therapeutics Corporation in September for Trevyent, a disposable pump and skin patch system or PatchPump® that delivers treprostinil in a steady flow over two days. Once an NDA is approved, the drug or device is allowed to be marketed to consumers.
Treprostinil, a prostacyclin PH-targeted therapy that helps relax the pulmonary arteries, is already FDA-approved. United Therapeutics sells treprostinil under the name Remodulin for continuous subcutaneous infusion. Treprostinil, which is also available generically, is also sold in oral and inhaled forms. The new PatchPump device for subcutaneously delivered treprostinil may offer convenience and predictable dosing for certain patients.
The Trevyent PatchPump system is pre-filled with treprostinil and is pre-programmed to deliver the drug for 48 hours. Trevyent has programmed audio and visual alerts for PAH patients to help them know when the drug is being delivered.
Originally developed by SteadyMed, now a subsidiary of United Therapeutics Corporation, the PatchPump device was tested in a study involving 60 healthy volunteers who received placebos through the device over a 48-hour period. SteadyMed reported positive safety and tolerability data from the study.
Trevyent was granted Orphan Drug Designation by the FDA in January 2016, and an NDA was filed by SteadyMed in July 2017. The FDA judged the original application to be incomplete and asked the company to collect and report additional information on the specifications and performance of the PatchPump device. The current FDA review process for the new Trevyent NDA should be completed by April 27, 2020, according to United Therapeutics.