HOUSTON, Nov. 2, 2006 (PRIMEZONE) -- Encysive Pharmaceuticals (Nasdaq:ENCY) announced that following discussions today with the U.S. Food and Drug Administration (FDA), the Company has submitted a complete response to the July 24, 2006 approvable letter issued by the FDA regarding the Company's New Drug Application (NDA) for Thelin(tm) (sitaxsentan sodium) 100 mg tablets. The FDA is currently evaluating Thelin as a potential new oral treatment for pulmonary arterial hypertension.
The Company expects to hear within approximately 30 days whether the FDA accepts the submission and if so, the FDA will establish a new PDUFA action date.
About Encysive Pharmaceuticals
Encysive Pharmaceuticals Inc. is a biopharmaceutical company engaged in the discovery, development and commercialization of novel, synthetic, small molecule compounds to address unmet medical needs. Our research and development programs are predominantly focused on the treatment and prevention of interrelated diseases of the vascular endothelium and exploit our expertise in the area of the intravascular inflammatory process, referred to as the inflammatory cascade, and vascular diseases. To learn more about Encysive Pharmaceuticals please visit our web site: www.encysive.com.
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This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected. Among those risks, trends and uncertainties are decisions by the U.S. Food and Drug Administration regarding whether and when to approve our drug application for Thelin (sitaxsentan sodium), as well as more specific risks, trends and uncertainties facing Encysive such as those set forth in its reports on Forms 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks, trends and uncertainties, any or all of these forward looking statements may prove to be incorrect. Therefore you should not rely on any such forward looking statements. Furthermore, Encysive undertakes no duty to update or revise these forward-looking statements. The Private Securities Litigation Reform Act of 1995 permits this discussion.