Oct. 10, 2000--CollaGenex Pharmaceuticals, Inc. (Nasdaq: CGPI - news) today released findings from Phase IV clinical trial of Periostat (R) (doxycycline hyclate 20 mg capsules) in a population of patients with severe generalized periodontitis. The study was conducted at the University of Pittsburgh Dental School and chaired by M. John Novak, DDS, PhD.
This single-center, placebo-controlled, double-blinded study evaluated the adjunctive benefits of Periostat over a period of nine months in a population of 24 severe generalized periodontitis patients who had undergone a practive-based treatment plan involving multiple courses of dental cleanings above and below the gum line. The majority of patients in the study were heavy smokers. Smoking is a known risk factor for the development of severe generalized periodontitis, and typically makes treatment of this group of patients challenging.
The results of the study showed significant clinical benefit in the patients on Periostat compared with those on placebo (sugar pill). In teeth exhibiting clinical symptoms of severe periodontitis (tooth pockets of 7mm or more), the adjunctive administration of Periostat resulted in average pocket reductions of up to 3mm, compared with less than 1.5mm in patients receiving the placebo pill along with standard therapy.
``The data from this study are unparalleled and clearly show the clinical benefit of Periostat when administered along with traditional therapy for adult periodontitis,'' said Dr. John Novak, Professor at the University of Pittsburgh School of Dental Medicine. ``An average reduction of 3mm in pocket depth can mean the difference between being able to maintain the teeth with conservative, non-surgical therapy versus more aggressive, surgical techniques. It is clear to me from the results of this study that Periostat should be recommended as part of routine therapy for patients whose periodontal status is compromised due to smoking.''
``Periostat has demonstrated an outstanding efficacy and safety record, with over 700,000 prescriptions written by US dental professionals having been filled by patients since launch in 1998, and the drug has undoubtedly made a significant contribution to the treatment of chronic adult periodontitis, an extremely common and potentially debilitating disorder,'' said Brian M. Gallagher, PhD, chairman, president and chief executive officer of CollaGenex. ``This new clinical study in a predominantly smoking population, representative of a significant percentage of all periodontitis sufferers, confirms the positive findings from large scale clinical studies and every day clinical experience in patients with more mild disease symptoms.''
Periostat is designed to suppress the activity of enzymes that are responsible for breaking down the connective tissues that hold the teeth in place. It is available as a capsule and prescribed by dentists for 3 to 12 months as an adjunct to the common deep dental cleaning procedure known as scaling and root planing. In extensive clinical trials, Periostat has been shown to reduce probing pocket depths and improve clinical attachment levels compared with scaling and root planing alone. In these trials, adverse events to Periostat were similar to those of a placebo (sugar pill). Periostat is contraindicated in children up to 12 years of age, in patients with a known hypersensitivity to tetracyclines and during pregnancy and for nursing mothers. |
