Galderma Laboratories Release: Newly Approved Epiduo Forte (Adapalene And Benzoyl Peroxide) Gel, 0.3%/2.5% Prescription Treatment Now Available For Acne Patients Nationwide

- Patients who struggle with hard-to-treat inflammatory acne now have a new, antibiotic-free option -

FT. WORTH, Texas--(BUSINESS WIRE)--Galderma Laboratories, L.P. today announced that Epiduo^® Forte (adapalene and benzoyl peroxide) Gel, 0.3%/2.5%, is now available in retail pharmacies nationwide and in Puerto Rico. It was recently approved by the U.S. Food and Drug Administration (FDA) for the once-daily, topical treatment of acne vulgaris.

“Acne, the most common skin condition in the United States, can have a wide-ranging negative impact on those with moderate to severe disease. Patients with significant acne suffer both emotionally, as it contributes to low self-esteem and depression, and physically, due to permanent physical scarring”

Epiduo Forte Gel offers patients and physicians a unique treatment that combines two antibiotic-free medicines in one gel and is proven to control moderate to severe inflammatory acne. Left untreated, inflammatory acne may lead to long-term, skin-health issues including scarring. With the highest-available concentration of the retinoid adapalene combined with benzoyl peroxide, Epiduo Forte Gel helps treat moderate to severe inflammatory acne, by reducing the inflammation and redness associated with acne, and by unclogging pores and killing bacteria under the skin. Epiduo Forte Gel can help to simplify the management of hard-to-treat acne, being a 2-in-1 combination product that comes in an easy to use pump for the treatment of acne on the face, chest, back or shoulders.

“Acne, the most common skin condition in the United States, can have a wide-ranging negative impact on those with moderate to severe disease. Patients with significant acne suffer both emotionally, as it contributes to low self-esteem and depression, and physically, due to permanent physical scarring,” said Jonathan S. Weiss, MD, a board certified dermatologist at Gwinnett Dermatology, P.C., Galderma consultant and leading clinical investigator for the phase 3 trials of Epiduo Forte Gel. “I am confident that the availability of Epiduo Forte Gel will provide relief for patients, as it is the first combination of these strengths of adapalene and benzoyl peroxide developed to treat moderate to severe inflammatory acne.”

The approval of Epiduo Forte Gel was based on a pivotal phase 3, multicenter, randomized, double-blind, 12-week, placebo-controlled study in which it met each of its primary efficacy endpoints when compared to placebo gel in 217 acne subjects. The study demonstrated superiority of Epiduo Forte Gel over placebo gel (33.7% vs 11.0%) in the overall study population (moderate to severe) at week 12 for the Investigator’s Global Assessment Success Rate and for changes in inflammatory (-68.7% vs -39.2%) and non-inflammatory lesion count (-68.3% vs -37.3%, respectively) (all P < .001). Additionally, subjects who were “severe” at baseline (50%) were required to go from “severe” to “clear” or “almost clear” within the 12-week trial to be considered a treatment success. More than half of study subjects treated with Epiduo Forte Gel reported a marked improvement in their severe acne (50.5%).

In the pivotal study of subjects with moderate to severe acne, Epiduo Forte Gel results were seen as early as one week, and more than 90 percent of subjects reported complete, significant or moderate improvement in their acne by week 12. Epiduo Forte Gel was shown to be safe, well tolerated, and can be considered for long-term use. Some study subjects (=1%) experienced skin irritation, eczema, atopic dermatitis and skin burning sensation while using Epiduo Forte Gel.

"At Galderma, we recognize the impact that acne has on various aspects of patients’ lives and we are committed to ensure all acne sufferers have suitable treatment options available by expanding our robust acne franchise,” said Todd Zavodnick, President and General Manager of Galderma Laboratories, L.P. “The availability of Epiduo Forte Gel provides moderate to severe acne patients with a safe, effective and antibiotic-free treatment option and also underscores Galderma’s commitment to combat antibiotic resistance and acne simultaneously.”

Additional information on Epiduo Forte Gel can be found in the full prescribing information and important safety information at www.epiduoforte.com.

About Acne

Acne is the most common skin condition in the United States, affecting more than 40 to 50 million people. Acne appears when pores clog with dead skin cells, and can have a wide-ranging negative impact on sufferers that includes both emotional and physical scars. Studies show that many people who have acne suffer from low self-esteem and depression, and that teens who believe they have “bad” acne were more likely to think about hurting themselves. Acne not only affects teenagers but also can be seen in men and women of all ages with research showing that the onset of acne is frequently seen in prepubescent patients.

When it comes to acne treatment, long-term use of antibiotics may be a contributing factor to the overall global antibiotic resistance issue. Propionibacterium acnes (P. acnes), a bacteria linked to acne, is increasingly becoming resistant to topical and oral antibiotics, which may potentially cause a decrease in treatment efficacy against acne.

About Galderma

Dating back to 1961, Galderma is now present in 80 countries with an extensive product portfolio to treat a range of dermatological conditions. The company partners with health care professionals around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin, hair and nails.

Strategic brands in the U.S. include Epiduo^® Gel, Oracea^® Capsules, Clobex^® Spray, Differin^® Gel, Mirvaso^® Gel, MetroGel^® Gel, Soolantra^® Cream, Vectical^® Cream, Tri-Luma^® Cream, Cetaphil^®, Benzac^® Acne Solutions, Restylane^®, Restylane^® Silk, Restylane^® Lyft, Dysport^® and Sculptra^® Aesthetic.

For more information, please visit www.galderma.com and www.galdermausa.com.

All trademarks are the property of their respective owners.

Important Safety Information

Indication: Epiduo^® Forte (adapalene and benzoyl peroxide) Gel, 0.3%/2.5% is indicated for the topical treatment of acne vulgaris. Adverse Events: In the pivotal study, the most commonly reported adverse reactions (=1%) in patients treated with Epiduo Forte Gel were skin irritation, eczema, atopic dermatitis and skin burning sensation. Warnings/Precautions: Patients using Epiduo Forte Gel should avoid exposure to sunlight and sunlamps and wear sunscreen when sun exposure cannot be avoided. Erythema, scaling, dryness, stinging/burning, irritant and allergic contact dermatitis may occur with use of Epiduo Forte Gel and may necessitate discontinuation. When applying Epiduo Forte Gel, care should be taken to avoid the eyes, lips and mucous membranes.

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.