Oral treprostinil: Preliminary Phase III data

Preliminary data from the double-blind, international Phase III FREEDOM-M trial in 228 evaluable patients showed that oral treprostinil met the primary endpoint of significantly improving median 6MWD from baseline to week 12 vs. placebo (25 meters vs. a 5 meter reduction, p=0.0125). The company said the population for the primary analysis consisted of the 228 patients who initially received placebo or twice-daily low-dose 0.25 mg oral treprostinil and had their doses titrated to effect over the 12-week trial. On secondary endpoints, oral treprostinil significantly improved a composite of 6MWD and Borg Dyspnea Score rating vs. placebo (p=0.0497), but did not significantly improve Borg Dyspnea Score, trough walk at week 11, Dyspnea Fatigue Index, WHO Functional Classification for PAH, time to clinical worsening or signs and symptoms of PAH (p>0.05 for all). ...