TRIUMPH-1 Trial of Viveta Meets Primary Endpoint

United Therapeutics and its subsidiary, Lung Rx, have completed TRIUMPH-1, the Phase III trial of Viveta for pulmonary arterial hypertension.

The randomized, double-blind, placebo-controlled trial included 235 patients on Tracleer (bosentan), an endothelin receptor antagonist, or Revatio (sildenafil), a phosphodiesterase-5 inhibitor. In addition to one of these oral therapies, patients were administered Viveta (treprostinil) or placebo in four daily inhalation sessions with a maximum dose of 45 micrograms.

The primary efficacy endpoint of the trial was the change in six-minute walk distance at 12 weeks measured 10–60 minutes after Viveta inhalation. Preliminary analysis demonstrated an improvement in median six-minute walk distance of approximately 20 meters in patients receiving Viveta compared with patients receiving placebo, United said.

Approximately 200 of the 212 patients who completed the trial entered an open-label continuation study. Roughly 160 patients are being treated with Viveta.