Galderma Laboratories announced today that the U.S. Food and Drug Administration (FDA) has granted the company approval to market its CLOBEX(R) (clobetasol propionate) Spray, 0.05% for the treatment of moderate-to-severe plaque psoriasis. CLOBEX(R) 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(R) 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(R) 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."
In controlled clinical trials, the following adverse reactions have been reported: burning, pruritus, dryness, pain, hyperpigmentation around resolving plaque, irritation and atrophy. CLOBEX(R) 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(R) Spray, 0.05% only for the minimum period necessary to achieve desired results.CLOBEX(R) Spray reflects the proven and well-known clinical profiles of CLOBEX(R) Lotion and Shampoo.
Available by prescription since September 2003 and June 2004 respectively, CLOBEX(R) 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.
