News | April 26, 2010

Pulmonary Arterial Hypertension Therapy Hits Market

A new formulation of Epoprostenol for Injection is stable at room temperature for up to 24 hours when diluted.

April 22, 2010 — An improved formulation of epoprostenol for the treatment of primary pulmonary arterial hypertension (PAH) and pulmonary hypertension is now commercially available.

Actelion Pharmaceuticals US, Inc., recently made the announcement regarding epoprostenol for injection, a therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe PAH, a chronic, life-threatening disorder characterized by abnormally high blood pressure in the arteries between the heart and lungs of an affected individual..

Simultaneously, the company has launched the PROSPECT registry, a multicenter, observational, U.S. registry that will provide additional clinical experience on patients being treated with epoprostenol for Injection.

Unlike other epoprostenol formulations, epoprostenol for injection is stable at room temperature for up to 24 hours when diluted and put into the pump for administration, eliminating the need for ice packs.

Accredo Health Group Inc., a wholly owned subsidiary of Medco Health Solutions Inc., will serve as the sole specialty pharmacy provider of epoprostenol for injection.

"Patients with late-stage PAH are extremely ill and have little energy, so a therapy that is convenient could make a big difference in their daily lives," said Vallerie McLaughlin, M.D., professor and director of the pulmonary hypertension program at the University of Michigan. "In addition, the PROSPECT registry will be valuable in enhancing our understanding of patient response to epoprostenol for injection, and will help physicians provide the most appropriate care to patients."

Epoprostenol for injection is indicated for the long-term intravenous treatment of primary pulmonary hypertension and pulmonary hypertension associated with the scleroderma spectrum of disease in New York Heart Association Class III and Class IV patients who do not respond adequately to conventional therapy. Epoprostenol for injection can be reconstituted with either sterile water for injection or sodium chloride 0.9 percent injection, eliminating the need for drug-specific dilutions.

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