The Food and Drug Administration (FDA) has cleared the Unity Subcutaneous Delivery System for Remodulin (treprostinil) Injection, also known as the RemUnity system (United Therapeutics and DEKA).
The RemUnity system is approved for subcutaneous delivery of Remodulin via a small pump, intended to have a service life of at least 3 years. Remodulin (United Therapeutics), a prostacyclin vasodilator, is indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group 1) to diminish symptoms associated with exercise. It is also approved for patients who require transition from epoprostenol, to reduce the rate of clinical deterioration.
The system will work in tandem with prefilled cartridges of Remodulin; DEKA will submit a 510(k) filing to the FDA to gain clearance for the cartridges (the RemUnity system launch is dependent on this clearance). The Companies are also developing a version of the system that includes disposable prefilled cartridges.
“We believe the RemUnity system reduces the risk of bolus dosing due to pump failures and provides wider arrays of notifications, alerts and alarms than current pumps,” said CEO of United Therapeutics, Martine Rothblatt. “Most importantly, the acoustic volume sensing technology and solid-state actuator of the RemUnity system enables it to control Remodulin flow rates without the use of a motor.”
RemUnity was developed in a partnership between United Therapeutics and DEKA Research and Development.
In addition to subcutaneous infusion, Remodulin can be administered through an external intravenous infusion pump or an implantable intravenous infusion pump.
For more information visit Remodulin.com.