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| |  FDA Approves Atridox Periodontal Disease Treatment FORT COLLINS, CO -- Sept. 8, 1998 -- The United States Food and Drug Administration has approved Atrix Laboratories, Inc.’s Atridox(TM) (doxycycline hyclate, 10.0%) in the Atrigel(R) delivery system, an advanced site-specific antibiotic therapy for the treatment of periodontal disease. Periodontal disease, a progressive infection of the gums and surrounding tissue, is estimated to affect 50 million Americans, yet only 7.5 million (15 percent) currently receive treatment. This common gum disorder is well-known as the leading cause of tooth loss in adults. An estimated $6.5 billion US is spent annually to treat this condition in the United States alone. Atridox combines Atrix's proprietary Atrigel drug delivery system with the antibiotic doxycycline to dramatically reduce the bacteria associated with periodontal disease. The innovative treatment is applied as a gel to the affected area, where it conforms to the shape of the periodontal pocket and solidifies, releasing doxycycline over a period of about seven days as it is bioabsorbed. Anesthesia is not needed. The Phase III clinical studies that led to this product's approval were the largest trials ever conducted for the treatment of periodontal disease. They included data from 822 patients at 20 study centres across the U.S. The studies showed that Atridox use resulted in a 1.2 millimetre reduction in pocket depth and a 0.8 mm gain in attachment, the two most commonly-used criteria to assess clinical effectiveness. Scaling and root planing -- the traditional mechanical removal of bacterial build-up – resulted in a 1.1 mm pocket depth reduction and 0.7 mm attachment gain. Data from another clinical trial confirmed a significant decrease in disease-causing bacteria at sites treated with Atridox without an increase in resistance to doxycycline. In clinical trials, the most common side effects associated with Atridox included tooth sensitivity, gum soreness and infections of the respiratory system. Atridox should not be used by patients hypersensitive to doxycycline or any other drug in the tetracycline class. "In light of its potentially serious nature, the management of periodontal disease is taking on increased significance," said Dr. Norman Stoller, professor of periodontics at the University of Colorado School of Dentistry, one of the clinical researchers for Atridox. "Atridox antibiotic therapy is a quick, easy, relatively painless, non-invasive treatment which can be used by dentists to help manage periodontal disease. “It is particularly useful for those patients with moderate to advanced disease and for patients who are manifesting recurrence of disease at the time of routine maintenance visits." As the most widespread infectious disease after the common cold, periodontal disease affects an estimated three out of four Americans over age 35. It begins as a painless infection of the gums, caused by a build-up of bacteria known as dental plaque. As the disease progresses, the gums increasingly separate from the teeth to form pockets, allowing the continued spread of plaque below the gumline. Without treatment, the bacterial build-up destroys the soft tissue and bone that hold the teeth. While periodontal disease is a chronic disorder, it can usually be successfully controlled with appropriate treatment, good home care and continuing visits to the dentist for maintenance therapy to prevent recurrence and further deterioration. Atridox will be marketed in the U.S. and Canada by Block Drug Corp.
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