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| |  Atridox Effective For Chronic Adult Periodontitis FORT COLLINS, CO -- June 16, 1999 -- Pivotal studies demonstrating the effectiveness of Atrix Laboratories, Inc.’s Atridox(R) (doxycycline hyclate) 10%, an innovative antibiotic therapy now gaining wide acceptance in treating periodontal disease, have been published in the Journal of Periodontology. The advanced site-specific treatment, introduced in late 1998, provides a fast, easy and effective treatment option for chronic adult periodontitis. Periodontal disease affects more than 50 million Americans. Atridox combines the company's unique Atrigel(R) bioabsorbable polymer with the antibiotic doxycycline to dramatically reduce the bacteria associated with periodontal disease. The treatment is applied locally without anesthesia to the infected periodontal pocket, where it reaches deeply into the problem area and solidifies, releasing the drug for about seven days as it bioabsorbs. The recently published clinical studies included data from 822 patients with moderate to severe periodontitis, and were conducted at 20 centres across the United States over a nine-month period. In the clinical trials, researchers evaluated the clinical efficacy of Atridox, oral hygiene and scaling and root planing (SRP) with respect to pocket depth reduction and attachment level gain, the two most commonly used criteria to assess periodontal treatment outcomes. The studies demonstrated that Atridox when used alone resulted in a mean pocket depth reduction of 1.2 millimetres (mm) and a mean attachment level gain of 0.8 mm. Scaling and root planing -- the standard mechanical removal of bacteria -- resulted in a mean pocket depth reduction of 1.1 mm and a mean attachment level gain of 0.7 mm. Both Atridox and scaling and root planing produced clinically and statistically superior results to the oral hygiene and placebo groups. Dr. Garrett said dentists have increasingly reported using Atridox as alternative therapy in maintenance patients whose clinical conditions may not require scaling and root planing. Many others have found Atridox useful in patients whose gums have not responded after traditional mechanical therapy, or as an additional treatment in deep or difficult sites. Growing numbers of dentists are also using Atridox prior to scaling and root planing, and as therapy in patients who refuse to receive the mechanical procedures. While periodontal disease is believed to affect as many as three out of four people over 35, it is estimated that only about 15 percent are currently receiving treatment for this common gum disorder that is a leading cause of adult tooth loss. 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 can destroy the soft tissue and bone that hold the teeth. Although 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. In clinical trials, Atridox was generally well tolerated. Side effects were similar to those of placebo. The most common side effects were: headache, common cold, gum discomfort, pain or soreness, toothache and tooth sensitivity. Atridox should not be used by patients who are hypersensitive to doxycycline or any other drugs in the tetracycline class. The use of drugs in the tetracycline class during tooth development may cause permanent discoloration of the teeth. Tetracycline drugs, therefore, should not be used in pregnant women, unless other drugs are not likely to be effective or are contraindicated.
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