Stiefel's Fabior foam approved for treating acne
Monday, May 14 2012 | Comments
received Food and Drug Administration
approval of Fabior (tazarotene) 0.1% foam for the treatment of acne vulgaris in patients aged 12 years or older.
Fabior is the only retinoid available in a topical foam formulation, according to Stiefel, a GlaxoSmithKline Plc
The approval was based on two double-blind Phase III trials, which involved a total of 1,485 patients aged 12 to 45 years with moderate to severe acne vulgaris. In both studies, the participants were randomized to receive Fabior or vehicle foam applied once daily for 12 weeks.
Treatment success was defined as a score of "clear" (grade 0) or "almost clear" (grade 1) on the Investigator's Global Assessment (IGA) scale and at least a two-grade improvement from the baseline score to week 12.
In the first study, the patients treated with Fabior had a 58 percent average reduction in inflammatory lesions from baseline, whereas the patients who received the vehicle foam had a 45 percent average reduction.
Total lesions were reduced by 56 percent on average in the Fabior group and by 39 percent in the vehicle foam group.
The proportion of participants who had a minimum two-grade improvement and an IGA score indicating "clear" or "almost clear" skin was greater in the Fabior group than in the vehicle foam group (29 percent vs. 16 percent, respectively).
In the second study, the patients treated with Fabior had a 55 percent average reduction in inflammatory lesions from baseline, whereas those who received the vehicle foam had a 45 percent average reduction.
The mean reduction in total lesions was 56 percent among the patients treated with Fabior and 43 percent among those treated with vehicle foam.
As in the first trial, the proportion of patients who had a minimum two-grade improvement and an IGA score indicating "clear" or "almost clear" skin was greater in the Fabior group than in the vehicle foam group (28 percent vs. 13 percent).
markets a topical cream formulation of tazarotene under the brand names Avage and Tazorac, as well as a topical gel of Tazorac. Avage is indicated as an adjunctive agent to treat facial fine wrinkling and facial discoloration in patients who use a comprehensive skin care and sunlight avoidance program. Tazorac is indicated for treating acne vulgaris and plaque psoriasis.
Allergan and Stiefel entered into a strategic collaboration in 2007 to develop and market new tazarotene products for dermatology indications.