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FDA Accepts Diquafosol NDA, Treatment for Dry Eyes
DURHAM, N.C., Sept. 9 /PRNewswire-FirstCall/ -- Inspire Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing Inspire's New Drug Application (NDA) for diquafosol tetrasodium ophthalmic solution, for the treatment of dry eye. In addition, the FDA stated in the Filing Review Letter that no potential filing review issues were identified during the 60-day preliminary review period.
Inspire submitted the diquafosol NDA on June 27, 2003. The FDA granted Priority Review status for the application in a letter received on July 31, 2003 and set December 24, 2003 as the target date for initial FDA action. The FDA typically conducts a preliminary review of NDAs during the 60 days following submission, and issues the Filing Review Letter within 74 days of submission (the letter is sometimes referred to as the 74-day letter).
Christy L. Shaffer, Ph.D., Inspire's CEO, stated, "We have been working actively with the FDA since the submission of our NDA and we are very pleased that the FDA did not identify any potential filing review issues in the preliminary review period. We are continuing plans to put a sales team in place to co-promote diquafosol with our partner, Allergan."
About Dry Eye
Dry eye is a painful, burning and irritating condition involving abnormalities and deficiencies in the tear film due to a variety of causes. It affects approximately 10 million North Americans and is one of the most frequent patient complaints reported to ophthalmologists and optometrists. The majority of dry eye patients rely on artificial tears to relieve symptoms.
Inspire Pharmaceuticals, Inc. discovers and develops new drugs to treat diseases characterized by deficiencies in the body's innate defense mechanisms of mucosal hydration and mucociliary clearance, as well as other non-mucosal disorders. Mucosal defense mechanisms are the natural way that the body defends its mucosal surfaces against dust, pollutants, bacteria and viruses. Inspire's lead product candidates target ophthalmic and respiratory diseases with inadequate current treatments and which represent large therapeutic market opportunities. Inspire has development and commercialization alliances with Allergan, Inc., Santen Pharmaceutical Co., Ltd. and Kirin Brewery Co., Ltd., and has a collaboration with Cystic Fibrosis Foundation Therapeutics, Inc. Inspire's products are based on proprietary technology relating to P2Y2 receptors and to non-P2Y2 receptors that show therapeutic promise, including P2Y12.