Graceway receives FDA approval for Zyclara Cream to treat actinic keratoses

Graceway Pharmaceuticals, LLC (Graceway) announced today that the Food and Drug Administration (FDA) has approved Zyclara^® Cream, 2.5% for the treatment of actinic keratoses, determining it to be safe and effective for the treatment of clinically typical, visible or palpable actinic keratoses (AK). The new formulation may be used on the full face or balding scalp in a convenient 6-week dosing cycle.

"The addition of a 2.5% formulation of Zyclara Cream will provide healthcare practitioners greater flexibility when prescribing imiquimod therapy for patients with actinic keratoses," said Dr. Darrell S. Rigel, a clinical professor of dermatology at New York University Medical Center and a former president of the American Academy of Dermatology. "The lower concentration offers greater tolerability while maintaining the efficacy that has long been associated with imiquimod."

The clinical studies conducted with the 2.5% strength imiquimod formulation were intended to evaluate the efficacy and safety in the treatment for AK lesions on large areas of skin (greater than 25 cm²), full face or balding scalp. Of the four double-blind studies conducted to evaluate imiquimod 2.5% or 3.75% versus placebo, patients applying imiquimod 2.5% on a two weeks on, two weeks off, two weeks on dosing cycle experienced the least amount of local skin reactions from any of the treatment groups. In addition, 31 percent of patients using imiquimod 2.5% cream had complete clearance of AKs versus 6 percent for the placebo group.

Local skin reactions such as erythema are consistent with treatment response. Reported severe local skin reactions with the 2.5% concentration during the two-week treatment cycle regimen were notably less than the currently available 3.75% concentration: erythema (14% versus 25%), scabbing/crusting (9% versus 14%), ulceration (9% versus 11%), and flaking/scaling/dryness (4% versus 8%).

"I am excited about the addition of the new 2.5% strength to the arsenal of tools available to treat AK. The 2.5% strength treatment regimen maintains excellent efficacy with less skin reactions than the 3.75% strength. This represents a significant new treatment for AK in patients who are primarily concerned about irritation," said Jefferson J. Gregory, Chairman and CEO of Graceway.