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Treprostinil Data Presented at American Thoracic Society Conference Demonstrates Significant Clinical Progress in All Four Routes of Administration
Date:5/21/2008

levels of NT-pro-BNP, a plasma biomarker of cardiac function, in patients receiving inhaled treprostinil as compared to patients receiving placebo. Patients receiving inhaled treprostinil showed a median decrease in NT-pro-BNP levels of 57 pg/ml at 12 weeks, as compared to a median increase of 40 pg/ml at 12 weeks in those patients receiving placebo.

Dr. McLaughlin also highlighted the convenience of inhaled treprostinil, which is administered via four one-minute inhalation sessions per day.

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. 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. In addition to one of these oral therapies, patients were administered inhaled treprostinil or placebo in four daily inhalation sessions with a maximum dose of 54 micrograms per session over the course of the 12-week trial.

Oral Treprostinil

In Plasma Levels with Oral Treprostinil Dietholamine over a Wide Range of Doses in Patients with PAH, Dr. R. James White of the University of Rochester presented data from a 12-patient study showing that a sustained-release capsule of treprostinil administered twice daily allowed patients to maintain consistent therapeutic levels of treprostinil in their bloodstreams in an equivalent therapeutic range to intravenously or subcutaneously administered treprostinil. The pharmacokinetic profile demonstrated that the release of treprostinil from the oral dosage form was sustained and supported the twice-daily regimen used in United Therapeutics' ongoing Phase 3 FREEDOM studies of oral treprostinil in patients with PAH. Dr. White's presentation also highlighted that the dose of oral treprostinil admin
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SOURCE United Therapeutics Corporation
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