ENCYSIVE SUBMITS NEW RESPONSE TO THELIN APPROVABLE LETTER

Encysive Pharmaceuticals announced it has provided the information requested by the FDA in its most recent letter to the company regarding the its response to an approvable letter for Thelin (sitaxsentan sodium) 100-mg tablets. The submitted information is Encysive's response to the FDA's determination that the company's earlier submission was not complete. The FDA is currently evaluating Thelin as a potential new oral treatment for pulmonary arterial hypertension.

The company had received an FDA approvable letter for Thelin in March requesting additional clinical trial work. After responding, Encysive received another approvable letter in July, which addressed an issue not resolved in the company's response and again offered the alternative of conducting additional trials. Additionally, the FDA provided recommendations on the company's risk management plan.

If the FDA accepts the new submission as a complete response, it will establish a new Prescription Drug User Fee Act action date.

The European Commission approved 100-mg Thelin tablets in August.