D1: Stiefel Laboratories

Stiefel Laboratories

Stiefel Laboratories is a specialty pharmaceutical company that develops dermatology products based on innovative delivery vehicles. Stiefel creates many products in house: from formulation, pre-clinical and clinical studies and regulatory filings to branding, marketing and sales.

A formulation team at Stiefel Research Australia has developed technologies for creating unique, cosmetically elegant and clinically effective means for delivering medications to the skin – including the patented VERSAFOAM® vehicle. At the Center for Skin Biology in Palo Alto, Stiefel scientists connect the scientific understanding of skin diseases with improved treatment options.

Together, the Center for Skin Biology and Stiefel Research Australia provide Stiefel Laboratories with a powerful strategic and competitive advantage in the development of prescription dermatology products that are state-of-the art in both formulation and pharmacology. The clinical development and regulatory expertise at Stiefel have enabled the company to obtain approval for four dermatological products formulated in VERSAFOAM-HF™ and two formulated in VERSAFOAM-EF™(see below), which have been successfully launched by the sales and marketing team.

The over 250-member Stiefel sales force works directly with the physicians who write 90% of the dermatology prescriptions in the U.S. This gives Stiefel insight into what patients and physicians want in prescription dermatology products. Close collaboration with practicing physicians also ensures that Stiefel's products maintain "top of mind" status in the marketplace.

Stiefel Laboratories Products Formulated with VERSAFOAM-HF™.

OLUX® delivers the super-potent topical corticosteroid clobetasol propionate in the VERSAFOAM-HF™ vehicle. OLUX is indicated for short-term topical treatment of the inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp, and for short-term topical treatment of mild to moderate plaque-type psoriasis of non-scalp regions excluding the face and intertriginous areas.

Treatment with OLUX beyond two consecutive weeks is not recommended and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.
Link to Package Insert

LUXÍQ® delivers the mid-potency topical corticosteroid betamethasone valerate in the VERSAFOAM-HF™ vehicle. LUXÍQ is indicated for topical application in the treatment of the inflammatory and pruritic anifestations of corticosteroid-responsive dermatoses of the scalp.

Systemic absorption of topical corticosteroids has caused reversible hypothalamic-pituitary-adrenal (HPA) suppression with potential for glucocorticosteroid insufficiency after withdrawal of treatment.

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EVOCLIN® delivers the topical antibiotic clindamycin phosphate in the VERSAFOAM-HF™ vehicle. EVOCLIN is indicated for topical application in the treatment of acne vulgaris.

The most common adverse events in clinical trials were headache and application-site reactions including burning, itching, and dryness.

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EXTINA® Foam, 2% is the first and only ketoconazole foam for the treatment of seborrheic dermatitis. EXTINA Foam is a unique formulation of ketoconazole delivered in the VERSAFOAM-HF™ vehicle. EXTINA Foam is indicated for the topical treatment of seborrheic dermatitis in immunocompetent patients aged 12 years and older.

EXTINA® Foam may result in contact sensitization, including photoallergenicity.

Link to Package Insert

Stiefel Laboratories Products Formulated with VERSAFOAM-EF™.

OLUX-E™ is a unique formulation of the super-potent topical corticosteroid clobetasol propionate delivered in the VERSAFOAM-EF (emollient formulation) vehicle. OLUX-E is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, which include eczema and psoriasis, in patients 12 years of age or older.

Treatment should be limited to 2 consecutive weeks. OLUX-E Foam has been shown to suppress the HPA axis.

Link to Package Insert

VERDESO™ delivers the low-potency topical corticosteroid desonide and was the first approved product formulated in Stiefel Laboratories’ proprietary VERSAFOAM-EF (emollient formulation) foam vehicle. VERDESO Foam is indicated for the treatment of mild to moderate atopic dermatitis in patients 3 months of age and older.

Treatment should not exceed 4 consecutive weeks. VERDESO Foam has the potential to suppress the HPA axis.

Link to Package Insert

We have several other products for a range of medical conditions in our pipeline featuring our patented VERSAFOAM formulations.

Other products using VERSAFOAM:
Mipharm S.p.A. Products
Men's Rogaine® Foam

For more information about Stiefel Laboratories, visit stiefel.com.