Press release
United Therapeutics Announces Top Line Data From the EXPEDITE Study of Remodulin Induction Prior to Orenitram Therapy
A short induction of Remodulin® (treprostinil) injection allowed study subjects to reach double the typical doses of Orenitram® (treprostinil)
About this update from United Therapeutics Corporation
[{"type":"text","content":"\nA short induction of Remodulin® (treprostinil) injection allowed study subjects to reach double the typical doses of Orenitram® (treprostinil) extended-release tablets than patients who did not have a Remodulin induction\n\n SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--\nUnited Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that a preliminary analysis of the EXPEDITE study in patients suffering from World Health Organization (WHO) Group 1 pulmonary arterial hypertension (PAH) demonstrated that 79% of patients in the study achieved an Orenitram (treprostinil) extended-release tablet dose of at least 4 mg three times daily (TID), for a 12 mg total daily dose at 16 weeks, after an up to eight week induction treatment period with Remodulin (treprostinil) injection. Detailed study results will be made available through scientific disclosure at upcoming medical conferences and in peer-reviewed publications.\n\n“The EXPEDITE trial represents a framework to get carefully selected PAH patients on clinically impactful oral doses of a critical class of medication safely and so much more timely,” said John Kingrey, M.D., director of the Pulmonary Hypertension center at INTEGRIS Baptist Medical Center. “I’m so pleased with how my patients did with this approach, as it really did expedite (pun intended!) their path to achieving increased prostacyclin dosages.”\n\n“We’re delighted with the preliminary results from the EXPEDITE study, which provided patients a way to reach efficacious doses in a shorter period of time without having to commit to long-term pump therapy,” said Meredith Broderick, Pharm.D., J.D., Senior Director of Global Medical Affairs at United Therapeutics. “Along with our other phase 4 studies, EXPEDITE demonstrates our commitment to optimize available treatment options in order to help PAH patients better manage their disease.”\n\nIn EXPEDITE, patients enrolled in the study achieved a mean total daily Orenitram dose of 16.4 mg at 16 weeks with 79% of study subjects reaching the study’s primary endpoint of a 12 mg total daily dose. Secondary outcome measures included six-minute walk distance (6MWD); the cardiac biomarker N-terminal pro-brain natriuretic peptide (NT-proBNP); WHO functional classification; echocardiography; risk scores; and health related quality ...