FDA approves Orenitram for PAH-United Therapeutics
The FDA has approved Orenitram (treprostinil) Extended-Release Tablets, from United Therapeutics, for the oral treatment of Pulmonary Arterial Hypertension (PAH) in WHO Group I patients to improve exercise capacity. Approval is based on the primary efficacy study, FREEDOM-M, which demonstrated that patients receiving Orenitram twice daily improved their median six-minute walk distance (6MWD) by +23 meters as compared to patients receiving only placebo.
As the sole vasodilator, the effect of Orenitram on exercise is small and Orenitram has not been shown to add to other vasodilator therapy. Two other Phase III studies (FREEDOM-C and FREEDOM-C2) did not demonstrate a benefit in exercise with median 6MWD at Week 16 (11 meters and 10 meters, respectively). The most common side effects reported in the clinical studies with Orenitram (placebo-corrected incidence >10%) are headache, nausea, and diarrhea.
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