Medical technology developer Medtronic, Inc. recently completed an application submission to the U.S. Food and Drug Administration (FDA) regarding the pre-market approval of their SynchroMed II implantable drug infusion system, which includes a new catheter design. The system is intended to be used by pulmonary arterial hypertension (PAH) patients for the intravenous delivery of the drug Remodulin (treprostinil), which is being developed by the United Therapeutics Corporation.
The Medtronic SynchroMed II programmable drug infusion system is designed to deliver drugs precisely for the treatment of patients who need ongoing therapy due to severe spasticity. It is usually used to distribute the proper amount of a muscle relaxant and antispasticity agent called intrathecal baclofen through a catheter. Medtronic and United Therapeutics now aim to expand its use to Remodulin, provided the FDA approves the pre-market submission.
In addition, the biotechnology company United Therapeutics is also expecting to be able to submit the combined therapy to the FDA as a supplement to its New Drug Application for Remodulin in the beginning of the next year. With the supplement, Remodulin may include in its label the therapy to be used in combination with the SynchroMed II implantable drug infusion system.
Remodulin is a prostacyclin vasodilator designed as therapy for PAH, which has been demonstrated to reduce symptoms related to exercise. United Therapeutics’ studies have revealed its effectiveness in diminishing NYHA Functional Class II-IV symptoms and etiologies in 58% of the idiopathic or heritable PAH patients, as well as 23% of congenital systemic-to-pulmonary shunts-related PAH, and 19% of connective tissue disease-related PAH.
The therapy is currently prescribed to be used as a continuous subcutaneous infusion or as continuous intravenous infusion. Despite that, United Therapeutics believes that given the risks inherent to the chronic use of central venous catheters, such as serious blood stream infections, only intolerant patients to the subcutaneous route, or patients who consider the risks warranted should have the drug administered through continuous intravenous infusion.
The biotechnology company United Therapeutics Corporation is developing and commercializing novel products for the treatment of chronic and life-threatening diseases such as PH. In addition to Remodulin, the company has also recently announced the completion of safely dosing the first of three patients cohorts for another experimental PAH therapy.