New Remodulin Delivery System and Dosage Form Approved
July 30, 2018 – The U.S. FDA has approved a new delivery system and dosage form for Remodulin® (treprostinil), manufactured by United Therapeutic. Remodulin is indicated to treat group 1 pulmonary arterial hypertension (PAH), as classified by the World Health Organization, and diminish symptoms of the condition associated with exercise. Remodulin is also used to treat patients who are transitioning off of GlaxoSmithKline’s Flolan® (epoprostenol), to reduce their rate of clinical deterioration.
In the past, Remodulin has been administered via subcutaneous injection or intravenously through a catheter implant. The newly approved delivery system and dosage form use the SynchroMed™ II pump from Medtronics. The pump, which is surgically implanted beneath the skin, delivers Remodulin through a catheter that remains in the patient’s blood vessel. Only 10% of patients who used the device for at least four years in clinical studies experienced problems with the pump.
Patients with the SynchroMed II pump will need regular injections to refill the pump’s medication reservoir. Depending on their Remodulin dose, these injections can be spaced as much as four months apart. The injections must be given by a qualified healthcare provider.
The new pump delivery system is expected to launch in the first quarter of 2019.