Galderma Receives FDA Approval for Clobex Spray for Psoriasis
Galderma Receives FDA Approval for Clobex Spray for Moderate-to-Severe Plaque Psoriasis
First Super-High Potency Steroid Spray Offers Unsurpassed Strength and Convenience
FORT WORTH, Texas, October 28, 2005 -- Galderma Laboratories announced today that the U.S. Food and Drug Administration (FDA) has granted the company approval to market its Clobex (clobetasol propionate) Spray, 0.05% for the treatment of moderate-to-severe plaque psoriasis. Clobex Spray is the only available super-high potency corticosteroid formulation that couples the clinically proven strength of clobetasol in an advanced, highly-convenient, non-aerosol spray formulation.
Clobex Spray was demonstrated to be safe and effective in two multi- center, randomized, double-blind studies involving 209 patients with moderate- to-severe psoriasis. In the first clinical trial, 82% of patients became clear or almost clear after four weeks of treatment, with 47% of these subjects becoming clear or almost clear in as early as two weeks. In a second study, 78% of patients were clear or almost clear after four weeks.
"Clobex Spray will be a welcome option for the millions of psoriasis patients who struggle with their treatment regimen," said Albert Draaijer, President, Galderma Laboratories, L.P. "The product's vehicle has been specifically designed to efficiently deliver clobetasol propionate to the skin. Above and beyond its unsurpassed efficacy, the easy application of this advanced vehicle will allow even the most active psoriasis patients to remain compliant with their therapy."
Available by prescription in a 2 fl oz bottle, the twice-daily use product should be applied directly on the lesion(s), avoiding the surrounding skin. Clobetasol propionate has been shown to suppress the HPA axis at the lowest doses tested. In controlled clinical trials, the following adverse reactions have been reported: burning, pruritus, dryness, pain, hyperpigmentation around resolving plaque, irritation and atrophy. Clobex Spray is not recommended for use on anyone younger than 18 years of age. The total dosage should not exceed 50 g (59 mL or 2 fl oz) per week. Patients should use Clobex Spray, 0.05% only for the minimum period necessary to achieve desired results.
Clobex Spray reflects the proven and well-known clinical profiles of Clobex Lotion and Shampoo. Available by prescription since September 2003 and June 2004 respectively, Clobex Lotion and Shampoo are clinically proven to reduce and/or eliminate the signs and symptoms of moderate-to-severe psoriasis.
Understanding the needs of psoriasis patients -- and providing products to address their special needs -- is a longstanding priority for Galderma. To better understand the impact of psoriasis on the lives of young adults, Galderma is partnering with the National Psoriasis Foundation (NPF) on a first-of-its-kind survey campaign directed to college-age individuals.
"College-age individuals seem to be affected by their psoriasis in ways that are perhaps different from than other patients," said Gail Zimmerman, Executive Director, NPF. "This new research will allow us to better understand this very unique patient population and introduce potential strategies to minimize their social and emotional impact." Results of the survey are expected for release in January.
About Psoriasis
Psoriasis is a common chronic skin disease that comes in different forms and varying levels of severity. More than 4.5 million adults in the U.S. have psoriasis, with nearly half of all patients experiencing the condition on their scalp. Psoriasis generally appears as patches of raised red skin covered by a flaky, white buildup, and is typically accompanied by intense itching and burning. Certain types of psoriasis can also produce a pustular appearance. In 2004, psoriasis accounted for an alarming 1.7 million patient visits and these numbers are expected to grow.
Source: Galderma Laboratories
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