Atrix Laboratories' acne drug Atrisone (5% topical dapsone gel) has successfully completed two pivotal Phase III clinical efficacy studies. Dapsone, the active compound in Atrisone, is an antibiotic with independent anti-inflammatory activity. Dapsone is highly insoluble and previously has only been commercially available as an oral tablet. The Atrix SMP technology provides a platform for highly water-insoluble drugs, such as dapsone, to be delivered topically at the site of disease. This proprietary technology is one of three topical drug delivery systems developed by Atrix' scientists.
In double-blind, randomized, vehicle-controlled studies involving over 3000 patients at over 100 centers around the U.S. and Canada. Atrisone statistically reduced inflammation and acne lesions. The company said it expects to file a marketing application with the FDA in July 2004. Atrisone is an antibiotic currently given as an oral tablet to treat leprosy.
Fujisawa Healthcare Inc. has licensed the marketing rights to Atrisone for acne and provided significant support for the development of the product.
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