Navigation Links
Galderma Announces Availability of Epiduo(TM) Gel, the First and Only Combination Treatment with a Retinoid and Benzoyl Peroxide to Treat Acne

Epiduo(TM) Gel Combines Retinoid and Benzoyl Peroxide in a Single Product; Performs Better than Either Component Alone

FORT WORTH, Texas, Jan. 6 /PRNewswire/ -- Galderma Laboratories, L.P. today announced the availability of Epiduo(TM) (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. 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. 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(TM) Gel treats both inflammatory and non-inflammatory lesions with no evidence of promoting antibiotic resistance, simplifying the management of mild-to-moderate acne. Additionally, studies indicate that Epiduo(TM) 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.

Epiduo(TM) 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.

"By targeting three out of the four causes of acne in a single medication, Epiduo(TM) 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(TM) Gel has an even more powerful treatment effect than either monotherapy without compromising tolerability."

A 517-patient Phase 2 trial of Epiduo(TM) Gel published last year in the Journal of the American Academy of Dermatology demonstrates that Epiduo(TM) 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(TM) Gel combination therapy worked quickly, with some patients showing improvements after one week of therapy.

A long-term safety and efficacy assessment of Epiduo(TM) 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.

These studies also showed that Epiduo(TM) Gel is well-tolerated, and rates of side effects were low in all Epiduo(TM) Gel groups. Clinical trials have demonstrated that Epiduo(TM) 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.

"The recent FDA approval and upcoming availability of Epiduo(TM) 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(R), MetroGel 1%(R) , Rozex(R), Clobex(R), Tri-Luma(R), Loceryl(R), Cetaphil(R), Silkis(R) and Epiduo(TM).

For more information on Galderma, visit

Important Safety Information

Epiduo(TM) 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(TM) 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(TM) 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(TM) Gel. Epiduo(TM) 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, or call 1-800-FDA-1088.

SOURCE Galderma Laboratories
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Galderma Associates Itself to Cartiers Womens Initiative Awards to Recognize Female Entrepreneurs From Around the Globe
2. Galderma Reaches Agreement to Acquire CollaGenex Pharmaceuticals
3. Galderma Pharma, S.A. and ZARS Pharma, Inc. Extend Agreement to Cover Worldwide Rights for Pliaglis(TM)
4. ZARS Pharma Announces Worldwide License Agreement With Galderma Pharma S.A. for Pliaglis(TM), a Topical Local Anesthetic
5. Galderma Announces HSR Clearance for Its Proposal to Acquire CollaGenex Pharmaceuticals
6. Galderma Completes Tender Offer for CollaGenex
7. Galderma announces approval for Differin gel 0.1 percent in Japan
8. HHS Announces $75 Million in Supplemental Funding to States for Pandemic Flu Preparedness
9. CRC Health Group Announces Acquisition of Bayside Marin Recovery Center, San Rafael
10. UHW Announces: Antelope Valley Hospital Caregivers and Board Vote to Ratify First Union Contract With SEIU UHW-West
11. HEI, Inc. Announces Sale of RFID Division Assets
Post Your Comments:
(Date:11/27/2015)... ... , ... There is only one major question facing all law firms in ... question has not been an easy question to answer. Especially when the senior partners ... workforce don’t share the same discipline around working long hours. , In addition ...
(Date:11/27/2015)... ... 27, 2015 , ... According to an article published November 13th ... in Washington D.C. revolved around the fact that proper dental care, both at-home and ... the link between periodontal disease (more commonly referred to as gum disease) and diabetes. ...
(Date:11/27/2015)... ... November 27, 2015 , ... According to an ... the University of Toronto and the University of British Columbia suggested that laws requiring ... injuries. The article explains that part of the reason for the controversial conclusion is ...
(Date:11/27/2015)... ... November 27, 2015 , ... According to an article ... the way that they are handling security in light of the recent terrorist attacks ... in an attempt to stop an attack from reaching U.S. soil. Especially around special ...
(Date:11/27/2015)... ... November 27, 2015 , ... ... care in America. As people age, more care is needed, especially with Alzheimer’s, ... and medical professionals are being overworked. The forgotten part of this equation: 80 ...
Breaking Medicine News(10 mins):
(Date:11/27/2015)... , Nov. 27, 2015 Research and ... the "Global Intrauterine Devices Market 2015-2019" report ... --> In this report, the author the ... devices market for 2015-2019. To calculate the market size, ... following type of products: Hormonal IUDs and copper IUDs. ...
(Date:11/26/2015)... 26, 2015 Un nuevo enfoque ... para el cáncer avanzado.   --> ... fotodinámica de Bremachlorin para el cáncer avanzado.   ... inmunoterapia con la terapia fotodinámica de Bremachlorin para el ... . --> Clinical Cancer Research . ...
(Date:11/26/2015)... Nederland, November 26, 2015 ... Een nieuwe aanpak combineert immunotherapie met Bremachlorin-photodynamische ... ) --> ...      (Photo: ) ... Universitair Medisch Centrum (LUMC) blijkt ...
Breaking Medicine Technology: