Connetics Corporation, a specialty pharmaceutical company that develops and commercializes dermatology products, has announced that the US Food and Drug Administration (FDA) has approved Verdeso (desonide) Foam, 0.05 per cent for the treatment of mild-to-moderate atopic dermatitis. Verdeso, previously referred to as Desilux, is a low-potency topical steroid and is the first approved product formulated in Connetics' proprietary VersaFoam-EF emulsion formulation foam vehicle. Connetics expects to begin marketing Verdeso to physicians in the fourth quarter of 2006 in 50g and 100g trade unit sizes.
"Today's approval allows us to bring a new and valuable option to physicians for treating children and adults with atopic dermatitis," said Lincoln Krochmal, MD., executive vice president of Research and Product Development for Connetics. "We look forward to commercializing the first product in our patented emulsion foam vehicle, formulated with emollient ingredients, and our first product approved for pediatric use. The low-potency corticosteroid desonide in VersaFoam-EF has been shown in our clinical trials to be safe and effective in children as young as three months of age. The ethanol-free vehicle in Verdeso is intended to provide an elegant, moisturizing, non-stinging product that absorbs quickly into the skin and does not feel sticky like an ointment or cream. In our pivotal clinical trial, burning sensation at the application site was reported by 3 per cent of all treated patients and 1 per cent of paediatric patients between three months and three years of age."
Thomas G. Wiggans, chairman and CEO of Connetics, said, "We have established leading brands in the topical mid- and super-high potency steroid categories with Luxiq and OLUX, respectively. With the addition of low-potency Verdeso, Connetics now offers physicians a complete line of topical steroids with enhanced cosmetic elegance, which we believe leads to increased patient compliance and satisfaction. Verdeso is a strong strategic fit for our dermatology sales force as well as the pediatric sales force we acquired earlier this year. Looking forward, we anticipate the potential approval of a second product using the VersaFoam-EF technology, Primolux, with a January 2007 PDUFA date."