31 October 2022 - - US-based biotechnology company United Therapeutics Corp. (NASDAQ: UTHR) has posted a preliminary analysis of the EXPEDITE study in patients suffering from World Health Organization Group 1 pulmonary arterial hypertension demonstrated showing that 79% of patients in the study achieved an Orenitram (treprostinil) extended-release tablet dose of at least 4 mg three times daily, for a 12 mg total daily dose at 16 weeks, after an up to eight week induction treatment period with Remodulin (treprostinil) injection, the company said.

Detailed study results will be made available through scientific disclosure at upcoming medical conferences and in peer-reviewed publications.

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 ; 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 study.

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.

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 or a total daily dose of 12 mg or higher at week 16.