Atrix Laboratories Inc announced that enrollment has been completed for the pivotal Phase III clinical studies for Atrisone (5% dapsone topical gel) for the treatment of acne.
Over 2,900 patients are enrolled in these double-blind vehicle-controlled studies, which are being conducted in over 100 centers around the U.S. and Canada. Final patient evaluations are expected to conclude in late 2003 followed by a data collections/processing effort. Submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) is planned in mid-2004.
Fujisawa Healthcare Inc, the North American subsidiary of Fujisawa Pharmaceutical Co., Ltd., has licensed the marketing rights to Atrisone for acne and is providing significant support for the development of the product.
"When we initiated these studies, we knew this would be one of the largest and most extensive clinical evaluations ever conducted on an acne product," said Dr. Soe Than, vice president of clinical research at Atrix. "It is the hard work and effort of the Atrix team and the support of our clinical investigators that have allowed these studies to be conducted so efficiently and quickly to date."
David R. Bethune, chairman and chief executive officer at Atrix commented, "The fact that Atrisone is being studied in over 100 centers around North America means that a number of dermatologists will have knowledge of, and experience with, the product. Now, we look forward to the completion of the studies and the opportunity to evaluate the data."