Connetics Corporation, a specialty pharmaceutical company that develops and commercializes dermatology products, has commenced the phase III clinical programme for Desilux, a low-potency topical steroid, formulated with 0.05 per cent desonide in the Company's proprietary emollient foam delivery vehicle.
The clinical programme will focus on atopic dermatitis and is designed to include infants from three months of age and children up to 17 years old. Subject to a successful phase III trial outcome, Connetics intends to submit a New Drug Application to the US Food and Drug Administration by the end of 2005, an official statement said.
Desonide currently is one of the leading topical steroids prescribed by dermatologists in the low-potency dermatoses market. The low-potency steroid market has annual US sales exceeding $150 million. A Desilux approval would provide Connetics with its first low-potency steroid product and will expand the Company's topical steroid product offerings into all three of the market segments of the $1.0 billion topical steroid market. In addition to offering a low-potency topical steroid, Desilux will also be the Company's first product with a paediatric indication, the release adds.
The emollient foam delivery vehicle is an important advancement in topical steroid therapy. The vehicle, which received a patent in May 2004 was developed by Connetics as a cosmetically and functionally elegant formulation to displace emollient-based and ointment-based treatments.
"The commencement of our phase III clinical programme involving our patented emollient foam delivery vehicle is an exciting advancement for Connetics," Lincoln Krochmal, executive vice president of Research and Product Development for Connetics said adding, "We believe that incorporating a strong moisturizing benefit into our proprietary foam will provide a novel product in the market." Dr. Krochmal continued, "We have established the leading brands in the mid- and super-high potency steroid categories with Luxiq and Olux. With this low-potency foam steroid in development, we look forward to being able to offer dermatologists a complete line of topical steroids with enhanced cosmetic elegance, which we believe leads to greater patient compliance and increased patient satisfaction."
Connetics Corporation is a specialty pharmaceutical company focused on the development and commercialization of innovative therapeutics for the dermatology market.