Galderma receives a FDA approval for Clobex spray to treat plaque psoriasis
Thursday, November 03, 2005 18:00 IST Fort Worth, Texas
Galderma Laboratories has received an approval from the US Food and Drug Administration 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, randomised, 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, informs a company release.
"Clobex spray will be a welcome option for the millions of psoriasis patients who struggle with their treatment regimen. 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," said Albert Draaijer, president, Galderma Laboratories.
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. This new research will allow us to better understand this very unique patient population and introduce potential strategies to minimize their Results of the survey are expected for release in January," said Gail Zimmerman, Executive director, NPF social and emotional impact
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 US 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.
