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Phase III Studies for Dapsone Completed
FORT COLLINS, Colo., Jan. 6 /PRNewswire-FirstCall/ -- Atrix Laboratories, Inc. announced today the company's proprietary acne drug, Atrisone™ (5% topical dapsone gel) has successfully completed two pivotal Phase III clinical efficacy studies. Over 3,000 patients were enrolled in these double-blind, randomized, vehicle-controlled studies, which were conducted in over 100 centers around the U.S. and Canada.
"We are pleased to announce the successful completion of the largest clinical studies ever undertaken by this company," said Dr. Steve Garrett, senior vice president of clinical research. "The databases have been locked, and preliminary data analyses are complete. We will be working diligently to assemble the New Drug Application (NDA). Due to the large dataset and extensive preclinical work, we expect to submit to the U.S. Food and Drug Administration (FDA) in July of 2004."
Dapsone, the active compound in Atrisone, is an antibiotic with independent anti-inflammatory activity, formulated in Atrix's SMP™ technology. 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, right at the site of disease. This proprietary technology is one of three topical drug delivery systems developed by Atrix's scientists.
Source: Atrix Laboratories, Inc.