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news.The FDA has granted Galderma Laboratories approval to market its Clobex spray, for the treatment of moderate-to-severe plaque psoriasis. The treatment delivers the active ingredient clobetasol in a spray formulation.
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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.
“The product’s vehicle has been specifically designed to efficiently deliver clobetasol propionate to the skin,” said Albert Draaijer, president of Galderma Laboratories. “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.”
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 the disease.