Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.United Therapeutics' double-blind, randomized, placebo-controlled Freedom-C(2) Phase 3 trial evaluating treprostinil diethanolamine (oral treprostinil) for the treatment of pulmonary arterial hypertension (PAH) failed to meet primary endpoint of six-minute walk distance (6MWD) at Week 16.
Subscribe to our email newsletter
In the study, the patients were optimized on an endothelin receptor antagonist, a phosphodiesterase-5 inhibitor, or both.
The trial involved around 310 patients.
United Therapeutics’ president and chief operating officer Roger Jeffs said while they did not achieve a statistically significant result for this trial, they believe the positive results from their previously-announced Freedom-M study support an NDA filing of oral treprostinil in treatment naive patients.
"Given that treprostinil is already approved for use in PAH by subcutaneous, intravenous and inhaled routes of administration, we believe the data obtained from all Freedom trials support an NDA for oral treprostinil in this indication," Jeffs said.
"We will now focus on completing the NDA for filing by the first half of 2012."