FDA News

Inspire Announces FDA Approval Of AzaSite

(April 30, 2007)-- Inspire Pharmaceuticals, said that the U.S. Food and Drug Administration (FDA) has approved AzaSite ^{(azithromycin ophthalmic solution) 1% for the treatment of bacterial conjunctivitis. Inspire anticipates launching AzaSite in the latter part of the third quarter of 2007 and expects to generate $30 - $45 million in sales in the 2008 calendar year based on current manufacturing and commercial plans.}

AzaSite will offer patients a reduced dosing regimen compared to other currently available products for bacterial conjunctivitis. The recommended dosing regimen for AzaSite is one drop twice-a-day for two days, followed by one drop once-a-day for the next five days, for a total of nine drops in the affected eye.

In two Phase 3 clinical studies, AzaSite met the primary efficacy endpoint of clinical resolution in patients with confirmed bacterial conjunctivitis. Clinical resolution was defined as the absence of ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection. The most common adverse event in patients receiving AzaSite was eye irritation, which occurred in 1-2% of patients.

Inspire acquired exclusive rights to commercialize AzaSite for ocular infections in the United States and Canada from InSite Vision Incorporated in February 2007. AzaSite is azithromycin ophthalmic solution formulated in DuraSite^{, a novel ocular drug delivery system developed by InSite Vision. The product has patent coverage until 2019. Inspire will provide revised 2007 financial guidance in its first quarter 2007 financial results release on May 9th, incorporating estimated changes in 2007 revenues and expenses based on the upcoming AzaSite launch.}

Terrence P. O'Brien, M.D., Professor of Ophthalmology and Charlotte Breyer Rodgers Distinguished Chair in Ophthalmology, Bascom Palmer Eye Institute of the University of Miami, commented, “AzaSite is a significant new ophthalmic product for the treatment of bacterial conjunctivitis. This unique formulation of the well-known, broad-spectrum antibiotic azithromycin results in a convenient topical dosing regimen, requiring less than half the number of drops for effective treatment compared to currently available products. These attributes are particularly important when treating young children and busy adults.”

Christy L. Shaffer, Ph.D., President and CEO of Inspire, stated, “This is a very exciting time for Inspire as we build on our expertise in ophthalmology with the anticipated commercial launch of AzaSite. To take advantage of this opportunity, we are expanding our existing sales force to a total of 98 representatives who will call on targeted specialists and select pediatricians and primary care providers. This expansion will also help position us for potential future launches of products in our pipeline.”

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