Atrix Laboratories Inc. said data from two Phase III trials of Atridox,an antibiotic delivered in a biodegradable polymer, showed the drugwas effective in treating periodontitis, a progressive gum disease.
Charles Cox, Atrix's vice president of new business development,said the Fort Collins, Colo., company expects to file a new drugapplication (NDA) with the FDA for marketing clearance in early1997.
Atridox combines doxycycline, an FDA-approved member of thetetracycline class of antibiotics, with a biodegradabale polymerdeveloped by Atrix. The product is placed into an infected areaaround teeth and releases the antibiotic over seven days to kill thebacteria associated with periodontal disease.
Cox said studies revealed the antibiotic was present in the infectedgums at least three weeks after the treatment.
Results of the Phase III trials showed Atridox achieved statisticallysignificant results in treating periodontitis compared with a placeboand demonstrated clinical equivalence to scaling and root planing,which is the conventional method of removing bacterial plaques.
Cox said the importance of showing clinical equivalence to scalingand root planing is that Atridox can serve as a "faster, less painfuland more patient friendly" substitute to the mechanical approach.
If approved by the FDA, Atridox would be the first subgingivalantimicrobial treatment of its kind for periodontitis in the U.S.
Patients suffering from periodontal disease are first treated withscaling and root planing to remove bacteria and then must return tothe dentist every three to six months for repeat, or maintenance,procedures.
Atridox, Cox said, would be a substitute for maintenance scaling androot planing. In some patients, he added, the drug could be used inplace of the mechanical procedures altogether.
Atrix's NDA for Atridox will include a study of bacterial resistanceto doxycycline. That analysis is not complete, Cox said, butpreliminary results indicate resistance will not be a problem.
In the two Phase III trials, 758 patients were divided into four groups:one received a placebo; a second took Atridox; a third was treatedwith scaling and root planing; and a fourth was instructed in oralhygiene, which involved brushing and flossing regularly.
The placebo, drug and mechanical treatments were administered atthe beginning of the trials and the fourth month. The studies followedthe patients for six months after the second treatment.
The results showed Atridox performed better than a placebo and wasas effective as scaling and root planing when measuring improvementin infected gums. The data also demonstrated Atridox and themechanical scraping achieved statistical significance in treatingperiodontitis compared with oral hygiene. n
-- Charles Craig
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