CARLSBAD, Calif., Oct. 23 /PRNewswire/ -- SkinMedica, Inc., a specialty pharmaceutical company focused on developing, acquiring and commercializing products that treat dermatologic conditions and diseases and improve the appearance of skin, announced today that the U.S. Food and Drug Administration (FDA) has approved the company’s New Drug Application (NDA) for Desonate (desonide gel) 0.05% for treatment of mild to moderate atopic dermatitis. Desonate is a low potency topical steroid formulated in a proprietary water- based Hydrogel vehicle developed and patented by Dow Pharmaceutical Sciences, Inc. The patented formula is free from alcohol, fragrance or surfactants which can be irritating or drying to the skin of atopic dermatitis patients. Desonate was developed in a collaborative effort between SkinMedica and Dow Pharmaceutical Sciences, Inc. and will be available to physicians in first quarter of 2007.
“The relationship with Dow Pharmaceutical Sciences enables us to expand our pipeline of dermatology products and build a robust franchise in the $1 billion topical steroid market,” said Rex Bright, President and CEO of SkinMedica. “The launch of Desonate represents a significant addition to our portfolio of prescription and cosmeceutical dermatology products.” “We are pleased to have partnered with SkinMedica in the development and approval of this important product utilizing our patented Hydrogel technology,” said Bhaskar Chaudhuri, President and CEO of Dow Pharmaceutical Sciences.
Desonide is the leading low potency corticosteroid in the US dermatology market with a long history of proven safety and efficacy. Desonate is the first product to contain 0.05 percent desonide in an aqueous-based Hydrogel formulation free from alcohol, fragrances or surfactants. The safety and efficacy of Desonate was demonstrated in two Phase III clinical trials with a total of 582 mild-to-moderate atopic dermatitis subjects aged 3 months to 18 years. The results demonstrated a statistically significant treatment effect for Desonate compared to placebo in both primary and secondary endpoints.
The patented formula is designed to provide a comfortable, non-irritating, silky smooth feel that will not leave a greasy residue. In two pivotal clinical trials, application site burning was reported by only 1% and pruritus (itching) by less than 1% of all treated patients. The product is approved for use in children over three months of age and for adults who suffer from the chronic itching and inflammatory symptoms of atopic dermatitis, commonly known as eczema. The safety and efficacy of Desonate was established for up to 4 weeks of use, and the product is contraindicated in patients with a history of hypersensitivity to any of the components of the preparation.
“Dermatologists, and all physicians who care for patients with eczema, will look forward to the use of this new formulation of a topical corticosteroid,” said Dr. Adelaide Hebert, Professor of Dermatology and Pediatrics at the University of Texas Medical School, Houston. “The safety and effectiveness of Desonate make this medication an optimal one for managing the dry, itchy skin of those patients who suffer from allergic dermatitis.”
More than 15 million patients have symptoms of atopic dermatitis, characterized by itchy skin, which can lead to rash, redness, swelling, crusting and scaling. The disease affects up to 20 percent of infants and young children, who continue to have symptoms as adults with significant impact on their quality of life. The exact cause is unknown, but genetics are considered a key factor. Steroids are the gold standard treatment for atopic dermatitis with more than $1 billion worth of prescriptions written annually by US physicians for inflammatory dermatoses.
For more information regarding Desonate, including its approved labeling, please visit http://www.fda.gov/cder/whatsnew.htm
About SkinMedica
SkinMedica is a privately held specialty pharmaceutical company marketing both prescription and cosmeceutical dermatology products. SkinMedica’s EpiQuin(R) Micro (4% Hydroquinone) treats melasma and postinflammatory hyperpigmentation, VANIQA(R) (eflornithine hydrochloride) Cream, 13.9%, is the only FDA-approved prescription product for the treatment of unwanted facial hair in women, and NeoBenz(R) Micro, which contains a patented gradual-release formulation of benzoyl peroxide, treats acne. The company’s full line of cosmeceutical products, which is sold through physicians, includes TNS Recovery Complex(R) with NouriCel-MD(R) to help improve the health and appearance of aging skin. SkinMedica is based in Carlsbad, California. For more information, visit: http://www.skinmedica.com.
EpiQuin(R)Micro, NeoBenz(R) Micro, NouriCel-MD(R), SkinMedica(R), TNS Recovery Complex(R) and VANIQA(R) are trademarks of SkinMedica, Inc.
About Dow Pharmaceutical Sciences
Dow Pharmaceutical Sciences, Inc. is s privately held company that specializes in the development of topical drug products for pharmaceutical and biotechnology clients. Dow provides a full range of product development services including formulation and regulatory consulting, formulation optimization utilizing state-of-the-art in vitro permeation models, full analytical support, cGMP clinical manufacturing, and clinical labeling. Dow conducts dermatology studies at clinical sites in Vallejo and Davis California, and in Europe through its Bioskin Division, a full service dermatology CRO headquartered in Hamburg, Germany. Dow also supports all aspects of regulatory and clinical planning and development, including FDA meeting support, regulatory document preparation, and electronic IND and NDA submissions. For more information visit: http://www.Dowpharm.com
SkinMedica, Inc.
CONTACT: Jill LaVorgna, Rpr Marketing Communications, +1-212-317-1462,jill.lavorgna@rprny.com; or Rex Bright, SkinMedica, Inc., +1-760-448-3610,rbright@skinmedica.com
