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| |  Atridox Therapy Now Available In U.S. For Periodontal Disease FORT COLLINS, CO -- Nov. 12, 1998 -- Atrix Laboratories, Inc.’s Atridox(TM) (doxycycline hyclate, 10.0%) in the Atrigel(R) delivery system, is now available in the United States for the treatment of periodontal disease. This advanced site-specific antibiotic therapy provides a fast, easy, virtually painless and highly effective treatment option for the most common infectious disease after the common cold. Periodontal disease affects an estimated 50 million Americans, including three out of four people over age 35. However, only 7.5 million (15 percent) are currently receiving treatment for this common gum disorder, which is well known as the leading cause of adult tooth loss. Atridox combines the company'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 bioabsorbs. Anesthesia is not needed. Atridox is the first and only locally delivered antibiotic treatment for periodontal disease that has been proven effective as a stand-alone therapy to achieve significant improvements in both pocket depth and attachment level, the primary indications of long-term healing, as well as to reduce bleeding on probing. As a result, scaling and root planing -- the traditional mechanical treatment for periodontal disease -- is still an important and often critical procedure, but is not required with each Atridox application. The Phase III clinical studies that led to this product's approval were the largest trials ever conducted for the treatment of periodontal disease, including data from 822 patients at 20 study centres across the U.S. The studies showed that Atridox when used alone 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 standard mechanical removal of bacterial build-up to treat periodontal disease -- 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." Periodontal disease 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 growth 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, its progression can usually be arrested and its symptoms reversed with professional treatment, good home care and continuing visits to the dentist for maintenance therapy to prevent recurrence and further deterioration. Individuals with outward signs of periodontal disease, including bleeding or inflammation of the gums, are urged to see a periodontist or general dentist for diagnosis and appropriate treatment.
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