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Inspire continues talks with FDA on diquafosol

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DURHAM, N.C. — Inspire Pharmaceuticals Inc. met with the Food and Drug Administration in September 2006 to continue ongoing discussions over its diquafosol tetrasodium ophthalmic solution for dry eye syndrome, the company announced.

The efficacy of diquafosol was called into question when the drug failed to meet efficacy endpoints in a phase 3 trial conducted in February 2005. Based on the recent meeting, Inspire plans to provide the FDA with additional information regarding the drug and company officials expect to meet with the agency after it reviews that information.

"We believe our discussions with the FDA have been constructive but the overall program remains challenging and the outcome is uncertain," Christy L. Shaffer, PhD, president and CEO of Inspire, said in the release.