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Mar 11, 2008

Inspire, Second Phase 3 Cystic Fibrosis Trial

Feb 13, 2008 - Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today the initiation of TIGER-2, its second pivotal Phase 3 clinical trial with denufosol tetrasodium inhalation solution for the treatment of cystic fibrosis (CF).

TIGER-2 (Transport of Ions to Generate Epithelial Rehydration) is a 24-week, double-blind, placebo-controlled, randomized study comparing 60 mg of denufosol inhaled three times daily to placebo in approximately 350 CF patients with FEV1 (Forced Expiratory Volume in one second) greater than or equal to 75% of predicted normal. The trial's primary efficacy endpoint is change from baseline in FEV1 (liters) at the 24-week timepoint. Secondary endpoints include other lung function parameters, pulmonary exacerbations, requirements for concomitant CF medications and quality of life... Inspire's Press Release -