More data on diquafosol submitted to FDA

DURHAM, N.C. — The maker of diquafosol has amended a new drug application that was originally submitted to the Food and Drug Administration in 2003, according to a press release.

Inspire Pharmaceuticals noted in the release that it had received an “approvable” letter from the FDA in late 2003; since the initial NDA submission the company has completed two additional phase 3 trials on the dry eye drug.

The additional trials involved 800 patients, and the amended NDA focuses on “multiple analyses of ocular surface staining, including corneal staining and conjunctival staining.”

In a press release earlier this year, Inspire reported that its drug had failed to meet the primary endpoint in a phase 3 clinical trial and that an amended NDA would be submitted by the end of June.

Diquafosol “functions as an agonist at the P2Y2 receptor, stimulating the release of natural tear components targeting all three mechanisms of action involved in tear secretion – mucin, lipids and fluid,” the press release notes.

Inspire executives expect the FDA to act on the amended NDA within 6 months.

Allergan and Inspire are jointly working to develop and commercialize the drug.