FDA Approves Epiduo Gel

Galderma Announces Availability Of Epiduo Gel, The First And Only Combination Treatment With A Retinoid And Benzoyl Peroxide To Treat Acne

(Fort Worth, Texas – January 6, 2009) Galderma Laboratories, L.P. today announced the availability of 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.1 The new prescription acne treatment received approval from the U.S. Food and Drug Administration in December, and will be on pharmacy shelves nationwide in the first quarter of 2009.

Because acne is caused by a multitude of factors, management of the condition has traditionally relied on combination therapy. 1a Established consensus guidelines recommend the use of a topical retinoid and an antimicrobial as first-line therapy for the majority of acne patients. By combining the two effective medications into one product, Epiduo Gel treats both inflammatory and non-inflammatory lesions with no evidence of promoting antibiotic resistance, simplifying the management of mild-to-moderate acne.1b Additionally, studies indicate that Epiduo Gel is more efficacious than either of its components used alone and significantly reduces total acne lesions by approximately 18 percent as early as the first week of treatment.2

Epiduo Gel also helps reduce the complexity of acne management by reducing the number of medications a patient has to remember to take on a daily basis, potentially increasing treatment adherence. The easy-to-apply Gel requires use only once a day.1c

"By targeting three out the four causes of acne in a single medication, Epiduo Gel offers doctors and patients an efficacious, easy-to-use tool to tackle mild-to-moderate acne," said Dr. Linda Stein Gold, director of clinical research and division head of dermatology at Henry Ford Hospital in Detroit. "Both adapalene and benzoyl peroxide have extensive histories of efficacy in treating acne, and the data demonstrates that Epiduo Gel has an even more powerful treatment effect than either monotherapy without compromising tolerability."

A 517-patient Phase 2 trial of Epiduo Gel published last year in the Journal of the American Academy of Dermatology demonstrates that Epiduo Gel reduced the median number of total acne lesions by more than 50 percent at the end of the 12-week study, which was significantly better than monotherapy with either adapalene (35.4 percent median reduction in total lesion count) or benzoyl peroxide (35.6 percent median reduction in total lesion count) alone. In addition, the Epiduo Gel combination therapy worked quickly, with some patients showing improvements after one week of therapy.2a

A long-term safety and efficacy assessment of Epiduo Gel published last year in the Journal of Drugs in Dermatology showed that discontinuation of the medication due to adverse events was low – occurring in only 2 percent of all patients. Additionally, none of the 452 patients withdrew from the study as a result of a lack of efficacy.1d

These studies also showed that Epiduo Gel is well-tolerated, and rates of side effects were low in all Epiduo Gel groups. Clinical trials have demonstrated that Epiduo Gel is well-tolerated from week 1 to week 52, with the majority of patients experiencing low levels of skin irritation associated with the drug.1e,2b

"The recent FDA approval and upcoming availability of Epiduo Gel are examples of Galderma's strong research and development capabilities and our ongoing commitment to providing innovative treatment options to patients," said Albert Draaijer, President, Americas, Galderma Laboratories, L.P. "As an industry leader in the dermatology space, our goal is to help improve physicians' abilities to offer individualized treatment approaches to the management of acne and other emotionally burdensome skin conditions."

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 1,000 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 dermatology brands include Differin®, MetroGel 1%® , Rozex®, Clobex®, Tri-Luma®, Loceryl®, Cetaphil®, Silkis® and Epiduo™.

For more information on Galderma, visit www.galdermaUSA.com.

Contacts:
Dale Weiss
E-mail: Dale.Weiss@galderma.com
Tel:817-961-5186

Important Safety Information

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.

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.

References:

1. Pariser, DM, et al. Long-term safety and efficacy of a new fixed-dose combination of adapalene 0.1% and benzoyl peroxide 2.5% for the treatment of acne vulgaris. Submitted.

2. Thiboutot, DM, et al. Adapalene-benzoyl peroxide, a fixed dose combination for the treatment of acne vulgaris: Results of a multicenter, randomized double-blind, controlled study.. J Am Acad Dermatol. 2007; 57(5): 791-9.

3. Comparing 2.5%, 5%, and 10% Benzoyl Peroxide on Inflammatory Acne Vulgaris. International Journal of Dermatology. 2008 http://www3.interscience.wiley.com/journal/119487516/abstract?CRETRY=1&SRETRY

4. Adapalene: A Review of its Use in the Treatment of Acne Vulgaris. Drugs. http://drugs.adisonline.com/pt/re/drugs/abstract.00003495-200464130-00005.htm;jsession

5. Gollnick H, Cunliffe WJ, 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):S1-S37.

6. Why Do I Get Acne? Nemours Foundation. http://www.kidshealth.org/teen/your_body/skin_stuff/acne.html.

7. Thiboutot D, Pariser DM, Egan N et al. Adapalene Gel 0.3% for the treatment of acne vulgaris: A multicenter, randomized, double-blind, controlled trial. J Am Acad Dermatol. 2006; 54:242-50.

Posted: January 2009

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Epiduo (adapalene and benzoyl peroxide) FDA Approval History

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