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United Therapeutics (NASDAQ:UTHR) said a short induction of Remodulin (treprostinil) injection allowed patients to reach double the typical doses of its other drug Orenitram (treprostinil) extended-release tablets than patients who did not have a Remodulin induction.
Remodulin and Orenitram both are approved to treat adults with pulmonary arterial hypertension [(PAH) WHO Group 1), a type of high blood pressure in the arteries of the lungs.
The company reported data from a phase 4 trial, dubbed EXPEDITE, of Remodulin induction followed by oral Orenitram optimization in patients with WHO Group 1 PAH.
In the trial, 36 patients were enrolled but 29 completed the study. Once enrolled, patients received intravenous or subcutaneous Remodulin 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 main goal was to evaluate the percentage of people achieving an Orenitram dose of 4 mg three times daily (TID) – or a total daily dose of 12 mg – or higher at week 16.
The company said patients achieved a mean total daily Orenitram dose of 16.4 mg at 16 weeks with 79% of people reaching the trial’s main goal of a 12-mg total daily dose.
“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, senior director of Global Medical Affairs at United.
The company noted that detailed results will be disclosed at upcoming medical conferences and in peer-reviewed publications.
