January 23, 2007
Stiefel Laboratories Receives FDA Approval of Olux-E (Clobetasol Propionate) Foam, 0.05% for Treatment of Psoriasis and Eczema
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™ (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.
"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.
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.
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™ Hydroethanolic Formulation which is neither hydrating nor drying, and VersaFoam-EF™ Emulsion Formulation, which provides many of the benefits of ointments, creams and emollient-cream vehicles. Products formulated with VersaFoam-HF include: OluxÃ® (clobetasol propionate) Foam, 0.05%; LuxiqÃ® (betamethasone valerate) Foam, 0.12%; and EvoclinÃ® (clindamycin phosphate) Foam, 1%. Products formulated with VersaFoam-EF are Olux-E™ (clobetasol propionate) Foam, 0.05%, and Verdeso™ (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.
About Psoriasis and Eczema
According to the National Institute of Health (NIH), between 5.8 and 7.5 million in the U.S. have psoriasis, which affects men and women of all age groups and races. Psoriasis is caused by excess inflammation and results in red, thickened, scale-like areas on the skin. There is currently no cure for psoriasis. Physicians most frequently help patients manage their disease and flare-ups with prescription-based steroid creams, ointments, gels, and solutions used to reduce inflammation and temporarily clear or control the disease. For more information on psoriasis, visit the National Psoriasis Foundation at www.psoriasis.org.
According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), more than 15 million people in the U.S. have symptoms of atopic dermatitis (eczema). Eczema is caused by excess inflammation and results in blistering, oozing, itchy patches. There is currently no cure for eczema. Physicians most frequently help patients manage their disease and flare-ups with prescription-based steroid creams, ointments, gels, and solutions used to reduce inflammation and temporarily clear or control the disease. For more information on eczema, visit the National Eczema Association for Science and Education at www.nationaleczema.org.
About Stiefel Laboratories, Inc.
Founded in 1847, Stiefel Laboratories (a privately held company) is the world's largest independent pharmaceutical company specializing in dermatology. The company manufactures and markets a variety of prescription and non-prescription dermatological products. Some of the newest and best-known brands include DuacÃ® (clindamycin, 1%-benzoyl peroxide, 5%) Topical Gel; EvoclinÃ® (clindamycin phosphate) Foam, 1%; LuxiqÃ® (betamethasone valerate) Foam, 0.12%; MimyX™ Cream; OluxÃ® (clobetasol propionate) Foam, 0.05%; Olux-E™ (clobetasol propionate) Foam, 0.05%; SoriataneÃ® (acitretin) capsules; Verdeso™ (desonide) Foam, 0.05%; BrevoxylÃ® Creamy Wash; OilatumÃ®; and SarnaÃ®. Its wholly-owned global network is comprised of more than 30 subsidiaries, including the recently acquired Connetics, manufacturing plants in six countries, research and development facilities on four continents, and products marketed in more than 100 countries around the world.
Stiefel Laboratories supplements its R&D efforts by aggressively seeking acquisitions of dermatological product lines and companies around the world. To learn more about Stiefel Laboratories, Inc., visit www.stiefel.com.
Full prescribing information can be found at www.OLUX-E.com.