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Galderma Laboratories Received FDA Approval of Differin(R) (adapalene) Lotion, 0.1%, the First Retinoid Available in Lotion Formulation


3/22/2010 10:39:35 AM

FORT WORTH, Texas, March 22 /PRNewswire/ -- 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.

About Galderma

Galderma, created in 1981 as a joint venture between Nestle and L'Oreal, is a fully-integrated specialty pharmaceutical company dedicated exclusively to the field of dermatology. The Company has a presence in 65 countries with over 1000 sales representatives and is committed to improving the health of skin with an extensive line of products across the world that treat a range of dermatological conditions including: acne, rosacea, fungal nail infections, psoriasis & steroid-responsive dermatoses, pigmentary disorders, medical solutions for skin senescence and skin cancers. With a research and development center in Sophia Antipolis, France, Galderma has one of the largest R&D facilities dedicated exclusively to dermatology. Leading U.S. brands include Epiduo® Gel, Differin® Gel, 0.3%, MetroGel® 1%, Oracea®, Cetaphil®, Tri-Luma® Cream, and Vectical® Ointment.

For more information on Differin Lotion, 0.1%, visit www.Differin.com; for more information on Galderma, visit www.galdermaUSA.com.

Important Safety Information About Differin Lotion, 0.1%

Differin® Lotion, 0.1% is indicated for the topical treatment of acne vulgaris in patients 12 years and older. Apply to affected skin (face and other areas of the body affected by acne) once per day avoiding the eyes, lips and mucous membranes. The most common adverse event reported with use of Differin® Lotion, 0.1% was mild to moderate dryness, which may be managed by use of moisturizers. Other side effects reported are redness, scaling, stinging and burning. These side effects typically resolve during the first 2 weeks of treatment, but speak to your doctor if they persist. You should avoid excessive exposure to sunlight and sunlamps while using Differin® Lotion, 0.1%, and using sunscreen products and protective clothing is recommended. Do not use irritating topical products that contain resorcinol, salicylic acid or sulfur when using Differin® Lotion, 0.1%, and avoid applying to areas that have been depilated using wax products. Differin® Lotion, 0.1% has not been tested in pregnant or nursing women, or with the elderly. Pregnancy Category C.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Important Safety Information About Differin Gel, 0.3%

Differin® Gel, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. During treatment with Differin® 0.1%, dryness, erythema, burning or pruritus can occur. These side effects differ in frequency depending on the formulation used of Differin® 0.1% (cream vs. gel). During treatment with Differin® Gel, 0.3%, signs of cutaneous irritation like redness, scaling, dryness, and/or stinging/burning may occur, but should be mild or moderate, occur early in treatment, and decrease thereafter. Other side effects that may occur from using Differin® Gel, 0.3% include skin discomfort, pruritus, and sunburn. Please see Full Prescribing Information.

Concomitant use of potentially irritating products or overexposure to sunlight or sunlamps, or extreme wind or cold, may increase the potential for irritation from both product concentrations. Use of sunscreen and protective clothing is recommended.

Important Safety Information About Epiduo® Gel

Epiduo® Gel is indicated for the topical treatment of acne vulgaris in patients 12 years and older. Apply to affected skin once per day, avoiding the eyes, lips and mucous membranes. The most common adverse events associated with use of Epiduo® Gel are redness, scaling, dryness, stinging and burning. In addition, you may also experience contact dermatitis and/or skin irritation. These side effects typically resolve during the first four weeks of treatment, but speak to your doctor if they persist. You should avoid excessive exposure to sunlight and sunlamps while using Epiduo® Gel and using sunscreen products and protective clothing is recommended. Do not use irritating topical products that contain resorcinol, salicylic acid or sulfur when using Epiduo® Gel. Epiduo® Gel has not been tested in pregnant or nursing women, or with the elderly. Pregnancy Category C. Please see Full Prescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

SOURCE Galderma Laboratories, L.P. Back to top RELATED LINKS http://www.galdermaUSA.com


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