FDA approves Differin (adapalene) gel, 0.3% for acne

Galderma Laboratories, L.P., has announced that the U.S. Food and Drug Administration (FDA) has approved Differin (adapalene) Gel, 0.3%, a new, higher concentration formulation of Differin (adapalene) 0.1%, a topical retinoid indicated for the treatment of acne.

Differin Gel, 0.3% provides physicians with a more potent formulation of adapalene that is efficacious enough to treat moderate to moderately-severe acne while still providing a favorable side effect profile. Differin Gel, 0.3% will be available by prescription by July 2007.

"Differin is the #1 prescribed topical acne product by dermatologists and new Differin Gel, 0.3% was developed in response to a need for more effective and well-tolerated treatment options to manage moderate to moderately-severe acne," said Albert Draaijer, President, Galderma USA. "Our clinical studies demonstrate that Differin Gel, 0.3% is effective in treating more severe cases of acne, while still offering the favorable tolerability profile which physicians and patients have come to expect from Differin. This combination of tolerability and efficacy will further improve outcomes for these patients.

Acne is one of the most common skin problems, affecting as much as 85 percent of the population, and can be challenging to manage. It affects more than 80 percent of young adults and teenagers. The appearance-altering skin disease can cause serious physical and emotional scarring if not treated appropriately.

According to therapeutic treatment guidelines published in the Journal of the American Academy of Dermatology, prescription topical retinoids, such as adapalene, should be used as first-line therapy for all acne cases, either alone or in combination with antibiotics. The exception to this is the most severe forms of the disease, which requires more aggressive treatment. In addition, a recent study published in the May 2006 issue of Archives of Dermatology, found that patients who are able to manage severe acne with a combination of antibiotics and topical retinoids are often able to maintain their clear skin by using gels alone after discontinuing use of antibiotics. Prolonged use of antibiotics can often lead to antibiotic resistance.

"The availability of a higher concentration of adapalene gel will provide dermatologists with a treatment strategy to better manage patients with difficult acne," said Dr. Diane Thiboutot, Professor of Dermatology at Penn State College of Medicine, and principal investigator of the multi-center study of Differin Gel, 0.3%. "We can now offer the benefits of adapalene in a potent formulation to our patients with more severe acne."

The efficacy, safety, and tolerability of Differin Gel, 0.3%, Differin Gel, 0.1%, and gel vehicle were compared in a multi-center, randomized, active and vehicle-controlled, double-blind, parallel group study conducted at 33 centers in the United States and Canada with a total of 653 patients with moderate to moderately-severe acne. While both concentrations of adapalene gel were found to be well-tolerated in this study, results revealed a clear dose-dependent response for all efficacy assessments: success rate (defined as clear or almost clear) and total, inflammatory, and non-inflammatory lesion counts. Differin Gel, 0.3% also demonstrated a fast onset of action as shown by significantly improved skin clearance as early as one week into the study. Additionally, despite the increase in adapalene concentration, the signs and symptoms of skin irritation observed for both concentrations were mild or moderate in severity and consistently decreased over time.

Differin Gel is a clear gel that is odorless, oil-free and alcohol- free. Differin Gel is applied directly to the face or affected area and is thought to work deep inside the pores to control the cause of the buildup that leads to the formation of acne. Differin Gel normalizes the improper accumulation of skin cells that plug the pores and effectively keeps them clear. Pores then begin to function normally again. Differin Gel not only helps to prevent the formation of new acne lesions, but also helps the lesions that are already present.

Differin Gel, 0.3% is available by prescription only.

During the first few weeks of treatment, itching, dryness, redness, burning or peeling may occur. Exposure to sunlight, including sunlamps, should be minimized during the use of Differin Gel. Use of sunscreen and protective clothing over treated areas is recommended when exposure cannot be avoided. As with other acne medications, overexposure to extreme wind or cold, or use of irritating skin care products may aggravate the skin.