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Back To Vidyya United Therapeutics Completes Enrollment In Phase III Study Of First Oral Therapy For Early-Stage Pulmonary Hypertension

Drug Is Already Approved For Use In Japan

United Therapeutics Corporation announced today that it has completed enrollment in its Phase III study of oral beraprost in patients with pulmonary hypertension. Approximately 116 patients in ten centers in the United States were randomized into the double-blind, placebo-controlled study in patients with moderate pulmonary hypertension.

Pulmonary hypertension is characterized by sustained elevations in pulmonary artery pressure, resulting in increased strain on the right side of the heart and ultimately right heart failure. Common early symptoms include shortness of breath, fatigue, angina and syncope (fainting spells), particularly with exertion.

Patients with advanced pulmonary hypertension are treated with a chronic, intravenous infusion of prostacyclin (Flolan(R)), the only currently approved therapy. The invasive nature of this treatment has made it less attractive to patients with moderate or early stage disease. As an orally active prostacyclin analog, beraprost is formulated as a tablet and therefore may provide a more acceptable treatment option for patients with the early stage of the disease. On October 16, 2000, United Therapeutics announced that it had filed an application with the FDA for marketing approval of a subcutaneous prostacyclin analog, Remodulin, for patients with moderate to severe pulmonary hypertension.

Beraprost is approved in Japan for the treatment of patients with primary pulmonary hypertension and therefore represents the first oral therapy indicated for the treatment of this disease. "We are excited about the development of beraprost in North America as it represents a significantly more convenient treatment alternative. The results of this study will form the basis of our regulatory strategy for this indication," said Roger Jeffs, Ph.D., Vice President of Research, Development and Medical for United Therapeutics.

Efficacy results from the study are expected to be available in 2002, as patients are being evaluated over a 12-month period. The study is assessing the effects of beraprost on exercise performance, cardiopulmonary hemodynamics, signs and symptoms of disease and quality of life. On 20 February 2001, United Therapeutics announced that it had completed enrollment in its Phase III study of beraprost in patients with intermittent claudication, another significant health application for the drug.

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Editor: Susan K. Boyer, RN
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