HOUSTON, Aug. 6, 2007 (PRIME NEWSWIRE) -- Encysive Pharmaceuticals Inc. (Nasdaq:ENCY) today announced that it has filed with the U.S. Food and Drug Administration (FDA) a request for formal dispute resolution to contest the third approvable letter that the Company received for its New Drug Application (NDA) for Thelin(tm). The Company originally submitted an NDA for Thelin(tm) to treat pulmonary arterial hypertension (PAH) in 2005. On June 15, 2007, the Company received a third approvable letter from the FDA stating that Encysive's clinical development program for Thelin(tm) did not demonstrate the evidence of efficacy needed for approval. Formal dispute resolution is an FDA process where sponsors can challenge regulatory decisions by bringing the dispute to the attention of FDA supervisors.
