Encysive Thelin pivotal trial
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Encysive plans to submit an NDA for Thelin (sitaxsentan) for pulmonary arterial hypertension "on or around the end of the first quarter in 2005." The company, formerly Texas Biotech, announced enrollment was complete for the Phase III Sitaxsentan To Relieve ImpaireD Exercise (STRIDE-2) study Sept. 8. The 240-patient, 18-week, double-blind, placebo-controlled trial includes a "third party bosentan [Actelion's Tracleer] arm," Encysive says. Topline data are expected in February 2005. The confirmatory trial is being conducted under FDA's special protocol assessment program (1Pharmaceutical Approvals Monthly Sept. 1, 2003, p. 17)...
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