You are here
NDA Submitted for Treprostinil, Potential Treatment of Pulmonary Arterial Hypertension
"We believe that an inhaled formulation of treprostinil will be a very desirable option for PAH patients," said Martine Rothblatt, Ph.D., United Therapeutics' Chairman and Chief Executive Officer. "The completion of the NDA filing is a huge milestone in United Therapeutics' quest to develop as many formulations of treprostinil as possible to create better, more convenient therapies to treat the debilitating effects of PAH along the full spectrum of the disease."
The ITRE NDA is principally supported by data from the TRIUMPH-1 Phase III clinical trial.
TRIUMPH-1 (TReprostinil Sodium Inhalation Used in the Management of Pulmonary Arterial Hypertension), was a randomized, double-blind, placebo- controlled trial of patients with PAH. ITRE is prepared once per day and administered in four daily inhalation sessions using the NEBU-TEC Optineb(TM) ultrasonic nebulizer, with each inhalation session taking approximately 1-2 minutes.
The TRIUMPH-1 clinical trial is one of the first pivotal trials to assess the incremental benefit of an add-on therapy in PAH patients who are already receiving an approved background therapy. 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. The majority of patients were New York Heart Association (NYHA) Class III (~98%) of varied etiologies, including idiopathic or familial PAH (~60%), collagen vascular disease associated PAH (~30%), and PAH associated with HIV, anorexigens or other associated conditions (~10%).
The primary efficacy endpoint of the TRIUMPH-1 clinical trial was the change in six-minute walk (6MW) distance at 12 weeks measured at peak exposure, defined by the trial protocol as 10-60 minutes after administration of ITRE relative to baseline. Analysis of the TRIUMPH-1 clinical trial results confirmed an improvement in median 6MW distance of approximately 20 meters (p
Source: United Therapeutics Corporation