FDA reviews NDA for new imiquimod formulation

Bristol, Tenn.- The Food and Drug Administration (FDA) is reviewing a new drug application from Graceway Pharmaceuticals for imiquimod 3.75 percent using a two-week cycle regimen for treatment of actinic keratoses (AKs).

Results from a phase 3 program evaluating short-course regimens of two concentrations of imiquimod cream (3.75 percent and 2.5 percent) demonstrated that imiquimod 3.75 percent, administered daily on two two-week treatment cycles, separated by a two-week non-treatment period, produced clearance rates superior to placebo for AKs.

Imiquimod 3.75 percent was also more effective than 2.5 percent, with comparable safety. The new data were presented at the recent American Academy of Dermatology Summer Academy Meeting in Boston.