United Therapeutics announced that the FDA has approved Orenitram (treprostinil) extended-release tablets for the treatment of pulmonary arterial hypertension (PAH) in WHO Group I patients to improve exercise capacity.
The approval was based on data from FREEDOM-M, the primary efficacy study that included patients with WHO functional class II to III symptoms and etiologies of idiopathic of idiopathic or heritable PAH or PAH associated with connective tissue disease.
Results showed that patients receiving Orenitram improved their median six-minute walk distance (6MWD) by +23m (P=0.013) as compared to patients receiving placebo.
Treprostinil, a prostacyclin vasodilator, causes direct vasodilation of pulmonary and systemic arterial vascular beds, and inhibition of platelet aggregation. Treprostinil is already available as a solution for IV or SC injection under the brand name Remodulin and as a solution for oral inhalation under the brand name Tyvaso.
Orenitram will be available in 0.125mg, 0.25mg, 1mg, and 2.5mg extended-release tablets in 100-count bottles.
For more information call (301) 608-9292 or visit Unither.com.