Galderma gains FDA approval for retinoid in lotion form

April 15, 2010

Galderma Laboratories has received FDA approval for adapalene lotion, 0.1% (Differin), a first-of-its-kind lotion formulation of the retinoid adapalene for treating acne.

Galderma Laboratories has received FDA approval for adapalene lotion, 0.1% (Differin), a first-of-its-kind lotion formulation of the retinoid adapalene for treating acne.

The lotion is designed for manageable efficacy, spreads easily, and comes in a handy pump dispenser. The lotion is indicated for treating acne vulgaris in patients aged 12 years and older. It can be applied on the face and other body parts affected by acne.

The approval was based on the results of 2 similarly designed 12-week, multicenter, controlled clinical studies. A total of 2,141 acne patients were treated with either adapalene lotion 0.1%, or placebo. At week 12, treatment with adapalene lotion, 0.1% showed statistically significant reduced numbers of total, inflammatory, and non-inflammatory lesions compared with placebo, respectively.

The side effect reported most often was dryness of the skin, noted by approximately 7% of patients using the lotion. Symptoms were primarily of mild-to-moderate severity. Some patients who used the lotion also noted some mild temporary skin irritation.