Galderma Laboratories' Differin Lotion receives FDA approval

Galderma Laboratories, L.P. today announced the U.S. Food and Drug Administration (FDA) approval of Differin® (adapalene) Lotion, 0.1%, the first-ever lotion formulation of the well-tolerated retinoid adapalene, for the treatment of acne. Differin Lotion, 0.1% will be available by prescription in April 2010.

Differin Lotion, 0.1% is formulated for tolerable efficacy, spreads easily and is available in a convenient, easy-to-use pump dispenser. Differin Lotion, 0.1% is indicated for the treatment of acne vulgaris in patients 12 years and older, and can be used on the face and other areas of the body affected by acne.

Approval was based on two 12-week, multicenter, controlled clinical studies of similar design, comparing Differin Lotion, 0.1% to vehicle in 2,141 total acne subjects. In Study 1, 1,075 subjects were randomized to Differin Lotion, 0.1% or vehicle. At baseline, subjects had between 20 to 50 inflammatory lesions and 30 to 100 non-inflammatory lesions. In Study 2, 1,066 subjects were randomized to Differin Lotion, 0.1% or vehicle. At baseline, subjects had the same inclusion criteria as in Study 1. Differin Lotion, 0.1% was shown to show statistically significant reductions in total, inflammatory, and non-inflammatory lesion count at week 12 compared to vehicle, respectively.

Signs and symptoms of local cutaneous irritation occurred mostly during the first two weeks of treatment and decreased thereafter, with dryness being the most often reported side effect in approximately 7 percent of patients using Differin Lotion, 0.1%. Most of the symptoms were transient with mild to moderate severity. Patients who used Differin Lotion, 0.1% in the study also reported mostly mild and transient skin irritation.

"The new formulation of well-tolerated Differin provides dermatologists with a once-daily treatment option to help keep acne under control," said Dr. Linda Stein Gold, director of clinical research and division head of dermatology at Henry Ford Hospital in Detroit and an investigator in the Differin Lotion, 0.1% clinical trials. "Because everyone's skin is unique, it is important to have multiple treatment options available in a variety of formulations, allowing dermatologists to take a truly individualized approach to the management of acne."

"Galderma is pleased to strengthen our portfolio of acne treatments with the addition of Differin Lotion, 0.1%, which features a pump delivery system to enhance patients' satisfaction with the product," said Francois Fournier, President, North America, Galderma Laboratories, L.P. "As the leader in the dermatology category, Galderma is committed to advancing treatment options for the management of acne, and other skin conditions that can have a significant emotional and physical impact on sufferers."

In addition to Differin Lotion, 0.1%, Galderma offers several other prescription treatment options for the management of acne, including Differin® (adapalene) Gel, 0.3%, and Epiduo® (adapalene and benzoyl peroxide) Gel, 0.1% / 2.5%, the first and only, once-daily, topical acne treatment that combines the well-tolerated retinoid adapalene, and benzoyl peroxide, a well-known antimicrobial with no evidence of promoting bacterial resistance.