DURHAM, N.C.--(BUSINESS WIRE)--Dec. 2, 2005--Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today that the U.S. Food and Drug Administration (FDA) has issued a second approvable letter for diquafosol tetrasodium ophthalmic solution. The FDA approvable letter included the following statement: “The submitted clinical studies fail to demonstrate adequate replication of results for the efficacy endpoints and therefore are insufficient to establish efficacy. Based on our review of the submitted data, consistent findings of corneal clearing need to be demonstrated to support the efficacy of the drug product.”
