Fort Worth, Texas, July 5, 2005 – Galderma Laboratories, L.P. today announces FDA approval of an exciting new product for the topical treatment of the inflammatory lesions of rosacea. MetroGel® (metronidazole) Topical Gel, 1% will be available by prescription July 29, 2005. The new medication incorporates a higher concentration of metronidazole in a new, technologically advanced vehicle.
One advantage of MetroGel® 1%, is the vehicle, incorporating HSA-3™, a combination of niacinamide, betadex and propylene glycol. The vehicle is a water-based formulation and contains no alcohol. Another advantage of the new product is that it allows for once-a-day dosing as opposed to twice-a-day for most other topical rosacea treatments.
"Rosacea is the fourth most common diagnosis made by dermatologists1, and we expect that MetroGel® 1% will eventually become the number one prescribed topical rosacea treatment," said Scott McCrea, Galderma product manager. Galderma brand MetroGel® 0.75% is currently the market leader in topical prescription rosacea treatment2.
Albert Draaijer, president of Galderma Laboratories, L.P. said, "The development and approval of MetroGel® 1% shows Galderma’s ongoing commitment to research and development of new treatments, for rosacea and other dermatological disease. We will continue to focus all of our resources on dermatology."
An estimated 14 million Americans suffer from rosacea3, characterized by redness, flushing and blushing on the face. However, many people in the early stages of rosacea mistake their symptoms for sunburn, rash or acne, causing them to delay diagnosis and treatment. The chronic disorder primarily affects the cheeks, chin, nose and forehead. Unfortunately, without treatment, rosacea can worsen over time, with the initial redness worsening and becoming more persistent. Visible blood vessels may appear, bumps and pimples may form on the face, eyes may appear to be bloodshot, and eventually, excess tissue may develop on the nose. Recent surveys reveal that almost 70 percent of rosacea patients suffer socially and that their self-esteem is affected by the condition3.
"This new product is an exciting new addition to our treatment options for rosacea," said Dr. John Wolf, chairman of the department of dermatology at Baylor College of Medicine in Houston, Texas. "Skin conditions like rosacea reach much deeper than the skin itself, causing low self-esteem and other psycho-social impact. Innovative products like MetroGel® 1% can help people improve their quality of life."
Galderma is one of the world’s leading pharmaceutical companies, focusing exclusively on research, development and marketing of dermatological products. Its expertise spans a broad spectrum of skin, hair and nail diseases.
Created in 1981, Galderma is a joint venture between Nestlé and L'Oréal. Galderma today employs 2,300 people and is headed worldwide by president & CEO Humberto C. Antunes. The parent company, Galderma Pharma, is headquartered in Lausanne, Switzerland. Galderma Laboratories, L.P. is the North American subsidiary.
The following adverse experiences have been reported with the topical treatment of metronidazole: burning, skin irritation, dryness, transient redness, metallic taste, tingling or numbness of extremities and nausea.
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1. Verispan PDDA 6/05
2. NDC Health 6/05
3. National Rosacea Society