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No go for Diquafosol
Inspire Announces Receipt of FDA Approvable Letter for Diquafosol
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."
Christy L. Shaffer, Ph.D., President and CEO of Inspire, stated, "In the approvable letter, the FDA strongly encouraged us to meet with them to discuss how best to move forward with the application. We intend to request this meeting in the near future. In addition, our Joint Development Committee with Allergan will be meeting next week to discuss strategies for the program. We plan to provide an additional update on this program following the FDA meeting and discussions with Allergan."
Dr. Scott Whitcup, Executive Vice President, Research & Development of Allergan, Inc., commented, "We are committed to supporting Inspire's effort to secure approval for diquafosol. Though the development of pharmaceuticals to treat dry eye disease is challenging, we still believe that diquafosol could potentially provide a valuable addition to the spectrum of treatments available to patients suffering from dry eye."
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."
Christy L. Shaffer, Ph.D., President and CEO of Inspire, stated, "In the approvable letter, the FDA strongly encouraged us to meet with them to discuss how best to move forward with the application. We intend to request this meeting in the near future. In addition, our Joint Development Committee with Allergan will be meeting next week to discuss strategies for the program. We plan to provide an additional update on this program following the FDA meeting and discussions with Allergan."
Dr. Scott Whitcup, Executive Vice President, Research & Development of Allergan, Inc., commented, "We are committed to supporting Inspire's effort to secure approval for diquafosol. Though the development of pharmaceuticals to treat dry eye disease is challenging, we still believe that diquafosol could potentially provide a valuable addition to the spectrum of treatments available to patients suffering from dry eye."
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