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New Drug Application for Inhaled Treprostinil Submitted to the U.S. Food and Drug Administration
Date:6/30/2008

al benefit of an add-on therapy in PAH patients who are already receiving an approved background therapy. The study population consisted of 235 patients who were optimized on an approved oral therapy for PAH, either bosentan (Tracleer(R)), an endothelin receptor antagonist, or sildenafil (Revatio(R)), a phosphodiesterase-5 inhibitor. The majority of patients were New York Heart Association (NYHA) Class III (~98%) of varied etiologies, including idiopathic or familial PAH (~60%), collagen vascular disease associated PAH (~30%), and PAH associated with HIV, anorexigens or other associated conditions (~10%).

The primary efficacy endpoint of the TRIUMPH-1 clinical 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 administration of ITRE relative to baseline. Analysis of the TRIUMPH-1 clinical trial results confirmed an improvement in median 6MW distance of approximately 20 meters (p<0.0005 at peak exposure, Hodges-Lehmann estimate and non-parametric analysis of covariance in accordance with the trial's pre-specified statistical analysis plan), in patients receiving ITRE as compared to patients receiving only background therapy. In addition, the 6MW distance at week 12 relative to baseline at trough exposure was also significantly improved, with an estimated treatment effect of approximately 14 meters (p<0.007). Secondary endpoints related to quality of life and change in NT pro-BNP, a plasma biomarker of cardiac function, were also significantly improved in the ITRE group as compared to the group receiving only background therapy (p<0.05). Other secondary efficacy measures, including change in Borg Dyspnea Score (shortness of breath test), NYHA functional class, signs and symptoms score, and time to clinical worsening, were not significantly different between the ITRE and background therapy only groups. Safety findings were typically those associated with the well-know
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