United Therapeutics Corporation (UTHR)

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5:31AM United Therapeutics: FREEDOM-C trial of oral treprostinil in pulmonary arterial hypertension does not meet primary endpoint (UTHR) 48.76 : Co announces the completion of its FREEDOM-C Phase 3 trial of treprostinil diethanolamine, an investigational sustained release oral formulation of treprostinil, a stable synthetic form of prostacyclin, in patients with pulmonary arterial hypertension. Preliminary analysis demonstrates that the trial did not achieve statistical significance for the primary endpoint, six-minute walk distance at Week 16. Overall, 132 (84%) oral treprostinil and 138 (90%) placebo patients completed Week 16 with an average dose of 3.0 plus or minus 1.9 mg twice daily in the oral treprostinil group. Discontinuations due to adverse events were 18 (11%) and 5 (3%) in the treprostinil and placebo groups, respectively. Adverse events associated with discontinuations were typically prostacyclin-related effects including headache, nausea and vomiting. Preliminary analysis of other secondary efficacy measures, including time to clinical worsening, change in combined 6MWD and Borg Dyspnea Score rating and Dyspnea-Fatigue index, WHO functional class, and PAH signs and symptoms, did not differ significantly between oral treprostinil and placebo. Further review and analysis of the FREEDOM-C preliminary results are ongoing.