Inhaled Treprostinil NDA Submitted to FDA

July 1, 2008

United Therapeutics and its wholly owned subsidiary, Lung Rx, have filed an NDA for an inhaled formulation of treprostinil in the treatment of pulmonary arterial hypertension (PAH).

The application is based on data from a randomized, double-blind, placebo-controlled Phase III trial in 235 patients who were on an approved oral therapy for PAH, according to United.

This therapy consisted of either bosentan (Tracleer), an endothelin receptor antagonist, or sildenafil (Revatio), a phosphodiesterase-5 inhibitor.