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Inspire's Phase 3 CF Trial, Using PARI's Nebulizer & Compressor, Shows Positive Top-Line Results
Date:6/12/2008

MIDLOTHIAN, Va., June 12 /PRNewswire/ -- On Friday, Inspire Pharmaceuticals (Nasdaq: ISPH) announced positive top-line results of the first Phase 3 trial with denufosol tetrasodium inhalation solution delivered via PARI's LC STAR nebulizer and PRONEB Ultra compressor for the treatment of cystic fibrosis (CF).

"We are pleased to see these positive top-line results and hope that Inspire's denufosol tetrasodium inhalation solution delivered via PARI's LC STAR and PRONEB Ultra compressor will become the first early intervention therapy available to CF patients," said Lisa Cambridge, director of Clinical Development at PARI Respiratory Equipment.

The trial demonstrated statistical significance for its primary efficacy endpoint, which was the change in FEV1 (Forced Expiratory Volume in One Second) from baseline at the trial endpoint (at 24 weeks or last observation carried forward). Patients treated with denufosol had a statistically significant improvement in FEV1 compared to placebo (45 milliliter treatment group difference, p = 0.047). On average, patients on denufosol improved relative to baseline whereas patients on placebo remained essentially unchanged.

The results were reported from the 24-week placebo-controlled portion of the 352-patient Phase 3 trial (TIGER-1) with denufosol tetrasodium inhalation solution for the treatment of cystic fibrosis. Additional information is available at http://www.inspirepharm.com.

The combination of PARI's LC STAR breath-enhanced nebulizer and PRONEB Ultra compressor provides for a quick treatment with high efficiency and minimal medication waste.

Denufosol for the treatment of cystic fibrosis has been granted Fast
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SOURCE PARI Respiratory Equipment, Inc.
Copyright©2008 PR Newswire.
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