FDA approves Extina for seborrheic dermatitis

Stiefel Laboratories, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved its new drug application for Extina (ketoconazole) Foam, 2% for the treatment of seborrheic dermatitis.

The approval, which the company received June 12, clears the way for the product to be sold and marketed in the United States.

Different from other treatments for seborrheic dermatitis, which contain ketoconazole 2% in a cream, gel or shampoo vehicle, Extina is administered using VersaFoam(R) HF(R) (hydroethanolic formulation) technology, a unique, versatile topical drug delivery vehicle that is quickly absorbed into the skin. Extina Foam proved to be superior to placebo foam in a Phase III clinical trial. Of subjects receiving Extina (R) Foam, 56% achieved treatment success based on an Investigator Global Assessment compared to 42% of subjects receiving vehicle foam. Stiefel Laboratories, the world's largest independent pharmaceutical company specializing in dermatology, acquired the proprietary VersaFoam HF technology with its December 2006 acquisition of Connetics Corporation.

"We are very pleased with the robust data obtained in the pivotal Phase III clinical trial evaluating the safety and efficacy of Extina," said Jim Hartman, Senior Vice President, U.S. Commercial Operations for Stiefel Laboratories. "It is exciting that this product, combining the proven efficacy of ketoconazole 2% in the patient-preferred foam delivery system will soon be available for patients with seborrheic dermatitis. It will provide dermatologists and other allied health professionals with an additional treatment option for this condition and allow patients to choose their preferred drug delivery method.

"Extina is representative of the robust and innovative product pipeline at Stiefel Laboratories," Hartman added.

Stiefel Laboratories plans to launch the product, which will be available only by prescription, later this year.

Extina(R) (ketoconazole) Foam, 2% is indicated for the topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older. Extina should be applied to the affected skin areas twice a day (morning and evening) for four weeks. Extina is administered via VersaFoam HF, which studies show offers consistent skin permeation, drug distribution and drug delivery. Additional patient benefits include versatility (Extina can be used on hair bearing and non hair-bearing skin), it absorbs quickly and it is non-drying with no residue.

Seborrheic dermatitis is a chronic, recurrent skin condition that affects three to five percent of the U.S. population. More than one million patients sought physician treatment of the disease in 2005. Seborrheic dermatitis is characterized by flaking, itching and redness and most often affects the scalp (dandruff), but also can affect skin on other parts of the body, including the face, chest, and the creases of the legs, arms and groin.