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 provides the clinically proven strength of clobetasol in a 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 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.
