STIEFEL WINS APPROVAL FOR DERMATOSES FOAM

Stiefel Laboratories announced that the FDA has approved Olux-E (clobetasol propionate) Foam, 0.05 percent. 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 and 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 in 50- and 100-gram canisters.

Olux-E has been shown to suppress the hypothalamic-pituitary-adrenal 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 percent for application site atrophy and 1.6 percent for application site reaction.

The VersaFoam vehicle is a 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.