Inspire's Phase 3 CF Trial, Using PARI's Nebulizer & Compressor, Shows Positive Top-Line Results
MIDLOTHIAN, Va., June 12, 2008 /PRNewswire/ -- On Friday, Inspire Pharmaceuticals 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 Track designation and orphan drug status in the United States by the FDA and orphan drug designation in Europe by the European Medicines Agency (EMEA).
About PARI Respiratory Equipment, Inc.
PARI is a leading worldwide developer and manufacturer of fast and efficient aerosol delivery systems for patients with asthma, chronic lung disease, and cystic fibrosis. PARI's worldwide vision is to improve the lives of those affected by respiratory diseases and those who care for them.
Maker of the world's leading breath-enhanced reusable nebulizer, the PARI LC PLUS, and the new PARI LC Sprint nebulizer line, PARI also manufactures the award-winning PARI TREK S compact compressor, Bubbles the Fish II aerosol mask, and durable PARI PRONEB Ultra II. PARI's Vortex anti-static valved holding chamber improves the aerosol deposition of metered dose inhalers (MDI's). PARI's North American headquarters is in Midlothian, VA with worldwide headquarters in Starnberg, Germany. Online at http://www.Pari.com
Additional information is available by contacting Ayars & Associates at 805-845-5682 or Ashley Weigand at 804-253-7274 x711.
CONTACT: Ayars & Associates, +1-805-845-5682; or Ashley Weigand,+1-804-253-7274, ext. 711, both for PARI Respiratory Equipment, Inc.
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Posted: June 2008