Verdeso Desonide Foam 0.05

Press Release: Stiefel Laboratories Receives FDA Approval Of Olux ...

Stiefel Laboratories Receives FDA Approval Of Olux-E (Clobetasol Propionate) Foam, 0.05% For Treatment Of Psoriasis And Eczema

CORAL GABLES, Fla. -- Stiefel Laboratories, Inc., the world's largest independent pharmaceutical company specializing in dermatology, today announced that the U.S. Food and Drug Administration (FDA) has approved Olux-E(TM) (clobetasol propionate) Foam, 0.05%. Olux-E is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, also known as psoriasis and eczema, in patients 12 years of age or older. In clinical studies, Olux-E was shown to safely and effectively reduce the symptoms associated with psoriasis and eczema. Olux-E is expected to be available in U.S. pharmacies by March 2007 in 50 gram and 100 gram canisters. Source: Stiefel Laboratories, Inc.

"My patients found Olux-E was easier to apply, disappeared more quickly into the skin, and did not have the sticky feel of an ointment or cream," commented Joel Schlessinger M.D., Study Investigator, Director of the Advanced Skin Research Center in Omaha, Nebraska, and President of the American Society of Cosmetic Dermatology and Aesthetic Surgery. "Foams just seem to be patient-preferred over gels, creams, ointments or solutions."

"I believe that this new foam will allow my patients to effectively and easily treat their body dermatoses. This vehicle is designed to be non-stinging and contains ingredients with moisturizing properties that I believe will be very appropriate for not only my patients with psoriasis but also those with eczema," commented Linda Stein Gold, M.D., Study Investigator and Director Dermatology Clinical Research, Henry Ford Health System in Detroit, Michigan.

About Olux-E

Olux-E is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older. Treatment should be limited to 2 consecutive weeks, and patients should not use greater than 50 grams per week. Olux-E has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis. The pooled incidence of local adverse reactions in controlled clinical trials for moderate-to-severe atopic dermatitis and mild-to-moderate plaque-type psoriasis with Olux-E was 1.9% for application site atrophy and 1.6% for application site reaction.

About VersaFoam®

The VersaFoam vehicle is a unique, patented and versatile foam formulation for delivering medications such as corticosteroids and antibiotics into the skin. There are two currently marketed VersaFoam formulations designed for specific patient preferences and skin types: VersaFoam-HF(TM) Hydroethanolic Formulation which is neither hydrating nor drying, and VersaFoam-EF(TM) Emulsion Formulation, which provides many of the benefits of ointments, creams and emollient-cream vehicles. Products formulated with VersaFoam-HF include: Olux® (clobetasol propionate) Foam, 0.05%; Luxiq® (betamethasone valerate) Foam, 0.12%; and Evoclin® (clindamycin phosphate) Foam, 1%. Products formulated with VersaFoam-EF are Olux-E(TM) (clobetasol propionate) Foam, 0.05%, and Verdeso(TM) (desonide) Foam, 0.05%. Products delivered via VersaFoam technology are easy to apply and spread, disappear into the skin quickly, and offer the cosmetic elegance of a fine skin care product. For more information on VersaFoam, visit www.versafoam.com.

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