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
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
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.