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news.United Therapeutics and its wholly-owned subsidiary Lung Rx have announced the completion of their Triumph-1 Phase III trial of Viveta, an inhaled formulation of treprostinil, in pulmonary arterial hypertension. Preliminary analysis demonstrates that the trial has met its primary endpoint.
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The primary efficacy endpoint of the trial was the change in six-minute walk (6MW) distance at 12 weeks measured at peak exposure, defined by the trial protocol as 10-60 minutes after inhalation of Viveta, relative to
baseline. Preliminary analysis of the Triumph-1 results demonstrates an
improvement in median 6MW distance by approximately 20 meters (p<0.0006,
Hodges-Lehmann estimate and non-parametric analysis of covariance in
accordance with the trial's pre-specified statistical analysis plan), in
patients receiving Viveta as compared to patients receiving placebo.
The Triumph-1 (treprostinil sodium inhalation used in the management of
pulmonary arterial hypertension) trial was a randomized, double-blind,
placebo-controlled trial of patients with severe PAH, a chronic, life-
threatening illness. The study population consisted of 235 patients who
were optimized on an approved oral therapy for PAH, either bosentan
(Tracleer), an endothelin receptor antagonist, or sildenafil (Revatio), a
phosphodiesterase-5 inhibitor.
Preliminary analysis of other secondary efficacy measures, including
change in Borg Dyspnea Scale rating (shortness of breath test), NYHA
functional class, time to clinical worsening (as defined by death,
transplant, atrial septostomy, hospitalization due to PAH, or initiation of
another approved PAH therapy), and the 6MW distance at treatment day 1, did
not differ significantly between the Viveta and placebo groups (p>0.05).
Analysis of two remaining secondary endpoints, quality of life and signs
and symptoms of disease (composite measure) is ongoing.
Roger Jeffs, president and chief operating officer of United Therapeutics, said: “These results build upon the treprostinil franchise we have
established with our previous approvals of subcutaneous and intravenous
Remodulin. We are excited that the primary efficacy analysis so
conclusively confirms the benefits of Viveta as combination therapy on 6MW
distance, as the delivery of treprostinil by inhalation following
regulatory approval will provide another important treatment option for
patients with this severe disease.”