FORT WORTH, Texas, June 20 /PRNewswire/ -- Galderma Laboratories, L.P., announced today 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(1) 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.(2)
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.(3) 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.(4)
“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.(5) 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.(6) 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.(7) 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.(8)
How Differin® Gel Works
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.
For more information on Differin® Gel, 0.3%, or Differin® Gel or Cream, 0.1% visit www.differin.com
About Acne
Acne vulgaris is one of the most widely experienced chronic skin diseases. In recent years, research has lead to a greater understanding of the pathogenesis of the disease.(9) The disorder begins with the onset of puberty and is thought to result from hormonal action on the skin’s oil glands (sebaceous glands) leading to plugged pores and outbreaks. It can be challenging to manage due to the variability in response to treatment and the need for long-term therapy.(10)
About Galderma Laboratories, L.P.
Created in 1981 as a joint venture between Nestle and L’Oreal, Galderma Laboratories is one of the leading dermatology companies in the world according to recent IMS D-Class survey. With a worldwide presence in 65 countries Galderma has over 1,000 sales representatives dedicated to dermatology. Galderma is a fully integrated specialty pharmaceutical company with a global sales and marketing structure and worldwide product development capability. Galderma provides innovative therapeutic skincare solutions to meet the needs of dermatology patients and physicians. The company is committed to improving the health of skin with an extensive line of products that treat a range of skincare conditions including: acne, rosacea, fungal nail infections, psoriasis, seborrheic dermatitis, hyper-pigmentation disorders, non-melanoma skin cancer and photo-damage.
With a new research lab in Sophia Antipolis, France Galderma has one of the largest research facilities dedicated to dermatology. Galderma is also poised to continue making significant impact on dermatology treatments with the introduction of exciting technology and products on the horizon. For more information see www.galdermaUSA.com
For more information on Galderma, visit www.galdermaUSA.com.
Differin and Galderma are registered trademarks. Copyright© 2007 Galderma Laboratories, L.P. Galderma Laboratories, L.P. 14501 N. Frwy, Fort Worth, TX 76177
(1) Wolters Kluwer, Phast Database, February 2007. (2) Thiboutot, D, Pariser, DM, Egan, N, et al. Adapalene gel 0.3 percent for the treatment of acne vulgaris: A multicenter, randomized, double- blind, controlled phase III trial. J Am Acad Dermatol 2006; 54(2): 242. (3) Gollinick, H, Cunliffe, W, Berson, D, et al. Management of Acne: A Report From a Global Alliance to Improve Outcomes in Acne. J Am Acad Dermatol 2003; 49(1): S5. (4) Thiboutot, D, Shalita AR, Yamauchi, PS, et al. Adapalene Gel, 0.1%, as Maintenance Therapy for Acne Vulgaris. Archives of Dermatology 2006; 142: 602. (5) Thiboutot, D, Pariser, DM, Egan, N, et al. Adapalene gel 0.3 percent for the treatment of acne vulgaris: A multicenter, randomized, double- blind, controlled phase III trial. J Am Acad Dermatol 2006; 54(2): 243. (6) Thiboutot, D, Pariser, DM, Egan, N, et al. Adapalene gel 0.3 percent for the treatment of acne vulgaris: A multicenter, randomized, double- blind, controlled phase III trial. J Am Acad Dermatol 2006; 54(2): 246. (7) Thiboutot, D, Pariser, DM, Egan, N, et al. Adapalene gel 0.3 percent for the treatment of acne vulgaris: A multicenter, randomized, double- blind, controlled phase III trial. J Am Acad Dermatol 2006; 54(2): 247. (8) Thiboutot, D, Pariser, DM, Egan, N, et al. Adapalene gel 0.3 percent for the treatment of acne vulgaris: A multicenter, randomized, double- blind, controlled phase III trial. J Am Acad Dermatol 2006; 54(2): 248. (9) Gollinick, H, Cunliffe, W, Berson, D, et al. Management of Acne: A Report From a Global Alliance to Improve Outcomes in Acne. J Am Acad Dermatol 2003; 49(1): S2. (10) Thiboutot, D, Pariser, DM, Egan, N, et al. Adapalene gel 0.3 percent for the treatment of acne vulgaris: A multicenter, randomized, double-blind, controlled phase III trial. J Am Acad Dermatol 2006; 54(2): 242.
Source: Galderma Laboratories, L.P.
