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FREEDOM-M Trial of Oral Treprostinil in Pulmonary Arterial Hypertension Meets Primary Endpoint
Date:6/6/2011

inil and -5 meters for placebo at week 12.  

The combined 6MWD and Borg Dyspnea Score rating (shortness of breath test) was significantly improved (p=0.0497).  Preliminary analysis of other secondary efficacy measures, including change in Borg Dyspnea Score rating, trough walk at Week 11, change in Dyspnea Fatigue Index, change in WHO functional class, time to clinical worsening (as defined by death, transplant, atrial septostomy, hospitalization due to PAH or at least a 20% decrease in six-minute walk and initiation of another approved PAH therapy), and PAH signs and symptoms did not differ significantly between oral treprostinil and placebo (p>0.05).

An analysis of all 349 FREEDOM-M patients demonstrates that those patients receiving oral treprostinil improved their median 6MWD by approximately 25.5 meters (p=0.0001, Hodges-Lehmann estimate and non-parametric analysis of covariance) as compared to patients receiving placebo.

Adverse events seen in the trial included headache, nausea, diarrhea, and flushing, which are common in patients receiving prostanoid therapy. Detailed analysis of adverse events is ongoing.  All patients in the trial had the option to continue receiving oral treprostinil in an open-label continuation study after completion of the 12-week period.  Of the 287 patients who were eligible to enroll, approximately 279 patients entered the open-label continuation study.  Of these, approximately 183 patients are currently being treated with oral treprostinil, with the longest duration of treatment exceeding three years.

“This is my dream come true,” said Martine Rothblatt, Ph.D., Chairman and Chief Executive Officer of United Therapeutics.  “PAH patients have approved therapies available to them by only three routes of administration – parenteral, inhaled and oral – and no therapy other than treprostinil is available by two of these.  
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SOURCE United Therapeutics Corporation
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