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Galderma Announces Availability of New Nozzle for Clobex(R) Spray for Moderate to Severe Plaque Psoriasis

April 13, 2010

FORT WORTH, Texas, April 13 /PRNewswire/ — Galderma Laboratories, L.P. today announced the availability of a new nozzle for Clobex® (clobetasol propionate 0.05%) Spray, a super-potent topical steroid indicated to treat moderate to severe plaque psoriasis in patients 18 years and older. The new packaging for Clobex® Spray, which will be on pharmacy shelves nationwide beginning later this month, features a more targeted nozzle delivery system to help psoriasis patients apply the product more easily and precisely to affected areas of the body and scalp.

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Psoriasis is a disorder in which skin grows and replaces itself too rapidly, causing a buildup of red, thickened areas with silvery scales. These scales flake off easily and often, causing the red areas to grow larger still — and the cycle continues. The National Institutes of Health estimates that as many as 7.5 million people in the U.S. have psoriasis. The condition usually develops in adults on the scalp, elbows, knees and lower back and can be painful, itchy and sometimes disfiguring in its moderate to severe forms.

Topical steroids are often prescribed by dermatologists to help people with psoriasis get their condition under control. Clobex® Spray is a powerful topical steroid that comes in easy-to-use 2 oz. and 4.25 oz. bottles with a non-aerosol, measured-dose spray, and provides clinically proven relief of common symptoms associated with psoriasis. The efficacy of Clobex® Spray was established in two independent clinical trials with 240 patients. On average, 8 out of 10 patients with moderate to severe plaque psoriasis became clear or almost clear after four weeks of treatment, and the efficacy of Clobex® Spray to treat moderate to severe plaque psoriasis has been confirmed in various clinical studies since its approval. The updated nozzle delivery system allows patients to target the application of Clobex® Spray to the affected areas of their body and scalp.

“Successful treatment of plaque psoriasis with topical steroids hinges upon a patient’s ability to regularly and accurately apply the medication to localized lesions,” said Dr. Fran Cook-Bolden, Director of the Skin Specialty Group and assistant clinical professor of dermatology at Columbia University in New York. “Clobex Spray is already a trusted, easy-to-use treatment option for psoriasis. I think the new nozzle will enhance the patient’s experience with this medication by making the application process simpler and more targeted, and will give patients the Clobex efficacy they’ve come to trust while limiting potential medication overuse.”

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 U.S. brands include Epiduo® Gel, Differin® Gel, 0.3%, MetroGel® 1%, Oracea®, Cetaphil® Cleansers and Moisturizers, Tri-Luma® Cream, and Vectical® Ointment.

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

Important Safety Information

Clobex® (clobetasol propionate 0.05%) Spray is indicated to treat moderate to severe plaque psoriasis and are not recommended for use on anyone younger than 18 years of age.

Use only as directed. The drug in Clobex® (clobetasol propionate 0.05%) Spray can pass through your skin. Too much of the drug passing through your skin may cause harm to your adrenal glands. To reduce this risk, your total combined use of these products should not exceed 50g per week (50mL or 2 fl. oz. Spray). Adrenal gland impairment can cause nausea, vomiting, fever and low blood pressure, so be sure to notify your doctor immediately if you experience any symptoms. Do not apply Clobex® Spray to your face, underarms, or groin and avoid contact with eyes and lips. If you are pregnant, trying to get pregnant or nursing, speak to your doctor before using Clobex® Spray for your psoriasis.

Other possible side effects with Clobex® Spray include mild burning, itching, redness, dry skin, acne, hair loss, thinning of the skin, and widening of small blood vessels in the skin. You should use Clobex® Spray for your psoriasis only for the minimum period necessary to achieve desired results, as directed by your doctor.

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.

SOURCE Galderma Laboratories, L.P.


Source: newswire



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