Inspire Pharmaceuticals Inc. (ISPH) Thursday reported positive top-line results from the first late stage trial with denufosol tetrasodium inhalation solution delivered via PARI's LC STAR nebulizer and PRONEB Ultra compressor for the treatment of cystic fibrosis.
The trial demonstrated statistical significance for its primary efficacy endpoint, which was the change in FEV1 or Forced Expiratory Volume in One Second from baseline at the trial endpoint. Patients treated with denufosol were indicated with a statistically significant improvement in FEV1 compared to placebo.
Denufosol indicated in the treatment of cystic fibrosis has been granted Fast Track status and orphan drug status by the FDA. The drug is also designated with orphan drug status in Europe by the European Medicines Agency.
Inspire said 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.
ISPH is currently trading at $5.01, up 2 cents.
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