United Therapeutics Corporation announced that the Food and Drug Administration (FDA) has accepted its investigational new drug application (IND) for the development of Remodulin by intravenous delivery for the treatment of pulmonary arterial hypertension.
A subcutaneous form of Remodulin is already approved by the FDA for the treatment of pulmonary arterial hypertension in patients with NYHA Class II-IV symptoms to diminish symptoms associated with exercise. Remodulin's active ingredient is a stable, long-duration variant of the natural molecule prostacyclin. Prostacyclin is believed to be essential for maintaining proper vascular tone and function but natural prostacyclin is highly unstable and has a very short duration of action.
"We are excited about the initiation of this registration effort for intravenous delivery of Remodulin to provide an additional prostacyclin therapy option. Given Remodulin's chemical stability and prolonged duration of action, it is a potentially more beneficial form of intravenous prostacyclin than is currently available in the United States. The only approved intravenous prostacyclin requires continuous refrigeration and can cause emergency distress to patients from infusion interruptions," said Roger Jeffs, President and Chief Operating Officer of United Therapeutics.