DURHAM, N.C.--(BUSINESS WIRE)--July 27, 2006--Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH - News) announced today the initiation of a Phase 3 clinical trial to evaluate its drug candidate, denufosol tetrasodium Inhalation Solution, in patients with mild cystic fibrosis (CF) lung disease. The initial Phase 3 clinical trial, which will be referred to as TIGER-1 (Transport of Ions to Generate Epithelial Rehydration), is designed to include a 24-week efficacy treatment period, followed by a 24-week safety extension period. The efficacy portion of the trial is a randomized, double-blind comparison of 60 mg of denufosol to placebo by inhalation three times daily in approximately 350 patients with mild cystic fibrosis lung disease at approximately 70 clinical centers across the United States. The trial will enroll CF patients aged five years and above. Use of standard CF therapies approved by the U.S. Food and Drug Administration (FDA), including dornase alfa, tobramycin, macrolides and digestive enzymes, will be permitted in the trial.
