This looks like a follow up to WHO in Geneva. Will probably get more European play than in NA
biz.yahoo.com
New ATRIDOX Therapy Unveiled for Wider Control of
Periodontitis
GENEVA, June 8 /PRNewswire/ -- Atrix Laboratories Ltd., a subsidiary of Atrix Laboratories, Inc. (Nasdaq: ATRX - news), announced today that it has unveiled important new technology for wider treatment of periodontal disease at the Europerio 3 meeting of the European Federation of Periodontology in collaboration with the World Health Organization in Geneva, Switzerland.
Known as ATRIDOX(TM) (8.8% doxycycline) in the ATRIGEL© delivery system, the unique antibiotic therapy recently received approval in 11 European countries under the Mutual Recognition Procedure. Marketing authorization from the individual countries is pending, and the product will become available in the months ahead. ATRIDOX is currently available inthe United Kingdom and United States.
``Chronic periodontitis, the destructive phase of the chronic inflammatory periodontal diseases, ranks as one of the most undertreated diseases in the world,'' said Professor Hubert Newman of the London-based Clinical Research Centre of the International Centre for Excellence in Dentistry, who has been part of the multi-center clinical study using the new therapy during teeth-cleaning procedures. ``With the availability of such products as ATRIDOX as a simple, quick and effective adjunctive treatment that fits well into everyday dental practice, it should now become possible to treat significantly more patients with chronic periodontitis.''
While periodontal disease affects an estimated three out of four adults over 35 years old, only 15 percent are currently receiving treatment.
ATRIDOX combines Atrix's ATRIGEL drug delivery system with the antibiotic doxycycline to dramatically reduce the bacteria associated with periodontal disease. ATRIDOX is indicated for use in adults with chronic periodontitis as an adjunct to conventional non-surgical management of 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 gives dental professionals and their patients a fast, practical, highly effective and pain-free therapeutic option for treating moderate to severe periodontal disease before more costly and invasive treatment is necessary, and for improving patient
compliance in treating maintenance patients,'' said Dr. Steve Garrett, vice president of clinical research at Atrix Laboratories.
He noted that recent clinical study results have shown that ATRIDOX used during thorough teeth cleaning is as effective asscaling and root planing -- the traditional mechanical removal of bacteria associated with periodontal disease -- while requiring one hour less treatment time and resulting in substantially less patient discomfort.
In the multi-center, controlled clinical study of 105 patients with moderate to advanced periodontal disease, pocket depths of 5 and 6 mm were reduced to 4 mm or less after three months in nearly 70 percent of those who received routine tooth cleaning and treatment with ATRIDOX. Of those treated with scaling and root planing, pocket depths of 5 and 6 mm were reduced to 4 mm or less in 60 percent of the cases after three months.
Also after three months, 52 percent of the sites treated with ATRIDOX showed a 2 mm or greater improvement in attachment level, compared with 43 percent of the sites treated with scaling and root planing.
Periodontal disease is believed to be the most common infectious disease after the common cold. It begins as a painless infection of the gums, caused by a buildup of bacteria known as dental plaque. As the disease progresses, the gums increasingly separate from the teeth to form pockets, allowing the continued accumulation of plaque below the gumline. Without treatment, the bacterial buildup and resulting inflammation destroy the soft tissue and bone that hold the teeth.
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 drugin the tetracycline class.
Atrix Laboratories, Inc. is a drug delivery and product development company whose patented technologies provide drug delivery from minutes to months. Atrix develops medical, dental and veterinary products in-house and also partners with large
pharmaceutical and biotechnology companies to apply its proprietary technologies to new chemical entities or to extend the life cycle of existing products. The company's first major product, ATRIDOX, for the treatment of chronic adult periodontitis, is currently on the U.S. market and was recently approved in a number of countries abroad. Additional information is available onthe Atrix Laboratories, Inc. Web site at atrixlabs.com .
Statements contained in this press release, which are not historical facts, are forward-looking statements, as the term is defined in the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to risks and uncertainties
which can cause actual results to differ materially from those currently anticipated, due to a number of factors, which include, but are not limited to, product demand, pricing, market acceptance, changing economic conditions, risks in product and technology development, the effect of the company's accounting policies and other risk factors discussed in documents filed by the company with the Securities and Exchange Commission from time to time.
SOURCE: Atrix Laboratories Ltd.
Fred McCutcheon |
