May 30, 2012 § Leave a Comment
GlaxoSmithKline (GSK) has received a FDA nod to market Fabior (tazarotene) in the United States to tackle blackheads and pimples in acne sufferers.
The new treatment will be in the form of a topical foam to treat acne, known in medical circles as acne vulgaris. Fabior Foam is indicated to treat acne patients 12 years and older who have moderate-to-severe acne. Prescribed in the 0.1 percent strength, Fabior Foam is touted as the only topical foam with FDA approval for treating acne in patients 12 years and older.
“Stiefel is dedicated to meeting the needs of patients and dermatologists, and we believe Fabior foam will be an important treatment option for people with moderate-to-severe acne,” Stiefel VP North America dermatology Jean-Christophe May said.
FDA approval of Fabior was based upon data from from two studies (phase III). Double-blind and randomized trials were conducted for 3 months (12 weeks) involving 1,485 patients who had moderate-to-severe acne. Among the participants, patients who received and applied Fabior Foam showed a significant reduction in their lesion numbers. Reactions to the foam were reported at the site where applied, which included redness, irritation, exfoliation, and dryness.
In the United States, while anyone can develop acne, it is seen primarily in young adults and adolescents, where hormonal changes are prevalent. However, certain cosmetics, some medications, and heredity/genetics can also play a role in developing acne. It’s estimated that up to 50 million people in the United States battle acne, reports the American Academy of Dermatology.
Stiefel Laboratoris, a subsidiary of GSK developed Fabior Foam.
Pharmacy Headquarters Blog (PharmacyHeadquarters.com) Editorial Staff Copyright 2012 – All rights reserved