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Galderma Announces FDA Approve of Differin Lotion

Galderma Laboratories, LP, recently announced that the FDA approved adapalene (Differin Lotion 0.1%), the first-ever lotion formulation of the well-tolerated retinoid adapalene, for the treatment of acne. The company said that Differin Lotion 0.1% will be available by prescription in April 2010.

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. According to Galderma, Differin Lotion, 0.1% is formulated for tolerable efficacy, spreads easily and is available in a convenient, easy-to-use pump dispenser.

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 patients. In Study 1, 1,075 subjects were randomized to Differin Lotion 0.1% or vehicle. At baseline, patients had between 20 to 50 inflammatory lesions and 30 to 100 non-inflammatory lesions. In Study 2, 1,066 patients were randomized to Differin Lotion 0.1% or vehicle. At baseline, patients 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% 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.

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