CORAL GABLES, Fla., July 17 /PRNewswire/ -- Stiefel Laboratories, Inc.
today 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® HF® (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
® 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® (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. For more information about Extina, please visit Extina.