Good Clinical Trial Results For Atrix' Periodontal Product

Atrix Laboratories, a US drug delivery and medical device company based in Fort Collins, Colorado, says that two pivotal Phase III trials have demonstrated that Atridox, its innovative drug delivery product incorporating doxycycline, is statistically and clinically superior to placebo and equivalent to conventional mechanical scaling and root planing. It is also said to be less painful and requires less treatment time for periodontitis, which affects an estimated 45 million adults in the USA alone.

The Phase III trials, started in January 1995, involved 20 dental centers across the USA and had 758 subjects who completed the nine-month study. The study design consisted of four parallel groups: Atridox, placebo, scaling and root planing and oral hygiene. Analysis of trial results demonstrated three findings with respect to attachment level gain and pocket depth reduction, the two primary clinical parameters used to assess outcomes after treatment of periodontitis. First, Atridox was statistically superior to placebo; second it was clinically equivalent to scaling and root planing; and third, both Atridox and scaling and root planing were statistically superior to oral hygiene alone.