Thursday, November 02, 2006

FDA Approves Steroid Foam For Atopic Dermatitis

The FDA has approved a new treatment for atopic dermatitis. Desonide (Verdeso Foam 0.05%), a low-potency topical corticosteroid from Connetics, was approved for the treatment of mild-to-moderate atopic dermatitis.As the first product approved using the company’s propriety emulsion foam (VersaFoam-EF), Verdeso is also the first product approved for Connetics that’s indicated for the treatment of pediatric patients. Approval was based on data from a double-blind, randomized study of 581 patients aged 3 months to 17 years old. In the study, success was defined as an improvement in the five-point Investigator’s Static Global Assessment (ISGA) of two grades from baseline to week 4. Study data indicate that 39% (152) of the 387 patients who underwent treatment with Verdeso achieved success with this therapy as compared to only 9% (18) of the 194 patients who received the foam vehicle. Previously known as Desilux, Verdeso will be marketed to physicians in the fourth quarter of this year. The therapy will be available in 50-g and 100-g trade unit sizes.