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United's Remodulin improves walk distance in hypertension study
By Angela McDaniels
Seattle, Dec. 19 - United Therapeutics Corp. said preliminary results of its 45-patient trial found that intravenous Remodulin produced an 83-meter median improvement in six-minute walk distance compared to placebo after 12 weeks in patients with class III/IV pulmonary arterial hypertension.
Supporting and secondary endpoint analyses of the study results are ongoing.
"We are very pleased that this first-ever placebo-controlled study of intravenous therapy in patients with pulmonary arterial hypertension overwhelmingly confirmed the efficacy of Remodulin," said Michael Wade, vice president of product development, in a company news release.
"We look forward to completing the confirmatory and secondary analyses and preparing the results for publication and further regulatory submissions."
The trial aimed to further assess the clinical benefits of Remodulin and was initially designed to enroll up to 126 patients, with interim assessments permitted after 33, 66 and 99 patients completed the study, the company said.
Enrollment of new patients was suspended in August after 45 patients had been enrolled, as recommended by the trial's independent data safety monitoring board.
Intravenous Remodulin is approved in the United States and Canada and is under review in Israel. Marketing applications have recently been submitted in the European Union and Switzerland, the company said.
United Therapeutics is a biotechnology company based in Silver Spring, Md., that develops and commercializes products for patients with chronic and life-threatening cardiovascular, cancer and infectious diseases.
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