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Inspire Announces Positive Results of Phase 2 Trial of Epinastine,Nasal Spray for Seasonal Allergic Rhinitis

DURHAM, N.C.--(BUSINESS WIRE)--May 8, 2007 - Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) today announced results of a Phase 2 dose-ranging clinical trial comparing epinastine nasal spray and placebo in patients with seasonal allergic rhinitis. For the primary endpoint of improvement in total nasal symptom score, dose-related effects were observed in the trial, with the higher dose (0.1%) achieving statistical superiority over placebo.

Christy L. Shaffer, Ph.D., Inspire's President and CEO, stated, "We were pleased that this trial identified an effective dose of epinastine in a nasal spray formulation, demonstrated evidence of acceptable tolerability and reported a low incidence of taste complaints with the two doses evaluated. We believe the taste profile is an important and potentially differentiating attribute for a nasal antihistamine spray."

The Phase 2 clinical trial was a 14-day, randomized, double-blind comparison of two doses of epinastine nasal spray (0.05% and 0.1%) to placebo in 569 subjects who had a documented history of seasonal allergic rhinitis to mountain cedar pollen. Of the subjects randomized in the trial, 95% completed the trial and no serious adverse events were reported. While the most common adverse event observed was bitter taste, it was only reported by 4% of subjects in the 0.05% group and by 5% of subjects in the 0.1% group.

The primary endpoint of the trial was the daily reflective change from baseline for total nasal symptom score (TNSS), averaged over the 14-day treatment period. The endpoint of TNSS conforms to the U.S. Food and Drug Administration's (FDA) draft guidance document for seasonal allergic rhinitis and includes runny nose, nasal congestion, itchy nose and sneezing. Results of the trial demonstrated statistically significant improvement (p less than or equal to 0.05) in reflective TNSS for the 0.1% dose group, compared to placebo. Changes in TNSS for the
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