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A 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
SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- United 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.
“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.”
“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.”
In 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 of life, as assessed using the emPHasis-10 questionnaire.
A previous real world dosing analysis showed an average Orenitram dose of approximately 6 mg daily after 16 weeks without the induction protocol studied by the EXPEDITE study1. In addition, scientific literature shows that higher doses of treprostinil have been associated with better outcomes for patients with PAH2.
Treatment with Orenitram, three times daily, was well tolerated and the safety profile was consistent with previous Orenitram studies in PAH. In the study, several well-known treprostinil adverse events such as headache, nausea, and vomiting tended to improve after transition to Orenitram from Remodulin.
About the EXPEDITE study EXPEDITE was a phase 4, multicenter, open-label 16-week study of Remodulin induction followed by oral Orenitram optimization in patients with PAH. Enrollment into the study was completed in May 2022 with a total of 36 patients enrolled. Twenty-nine patients completed the study. Once enrolled, patients were initiated on intravenous or subcutaneous Remodulin in an inpatient or outpatient setting and titrated to a minimum dose of 20 ng/kg/min over two to eight weeks. Patients were then transitioned to Orenitram over one to 21 days in the inpatient or outpatient setting. The primary endpoint was to evaluate the percentage of subjects achieving an Orenitram dose of 4 mg three times daily (TID) – or a total daily dose of 12 mg – or higher at week 16.
Secondary objectives of the study were to assess the effect of Orenitram treatment at 16 weeks after induction therapy with Remodulin on the following parameters:
