United Therapeutics announced that the Phase 3 FREEDOM-EV trial of Orenitram (treprostinil) extended-release tablets for patients with pulmonary arterial hypertension (PAH) has met its primary endpoint of delayed time to first clinical worsening event.
FREEDOM-EV was an international, multicenter, randomized, double-blind, placebo-controlled trial (N=690) that randomized patients to 3 daily doses of Orenitram or placebo. Patients with PAH were receiving background oral monotherapy of a PDE-5 inhibitor, an endothelin receptor antagonist, or a soluble guanylate cyclase stimulator.
The data showed 214 patients as having an adjudicated clinical worsening event, defined as death, hospitalization due to worsening of PAH, initiation of inhaled or infused prostacyclin treatment for PAH, disease progression or unsatisfactory long-term clinical response.
Orenitram in combination with background oral PAH therapy lowered the risk of a morbidity/mortality event vs placebo by 26% (P =.0391). The clinical benefit was seen across different subgroups based on age, gender, WHO functional class, PAH etiology, and background PAH therapy. Analysis of secondary endpoints, including the 6-minute walk distance and N-terminal pro-brain natriuretic peptide levels, is still ongoing. With regard to safety, Orenitram was generally well tolerated and its safety profile was similar to previous studies and known prostacyclin-related adverse events.
Based on the results of FREEDOM-EV, the Company plans to submit the data to the Food and Drug Administration in support of a label amendment. “Orenitram is already indicated to improve exercise capacity and has been an important part of the PAH treatment armamentarium since 2014. FREEDOM-EV expands on these benefits by demonstrating that Orenitram also delays disease progression,” said Martine Rothblatt, PhD, Chairman and Chief Executive Officer of United Therapeutics.
Orenitram, an oral prostacyclin vasodilator, is available as 0.125mg, 0.25mg, 1mg, 2.5mg, and 5mg extended-release tablets in 10- and 100-count bottles.
For more information call (877) 864-8437 or visit Orenitram.com.