US Launch Of Atridox For Periodontitis

Atrix Laboratories has received US approval to market Atridox(doxycycline hyclate 10%), its site-specific antibiotic treatment for chronic adult periodontal disease. The drug, based on Atrix' Atrigel drug delivery system, was launched in the USA by Block Drug shortly after approval, stimulating $10 million in milestone payments to Atrix.

Atridox is indicated for use in "the treatment of chronic adult periodontitis for a gain in clinical attachment, reduction in probing depth, and a reduction in bleeding on probing." The product will cost $40-$50 per unit, and comes as a two-syringe mixing system, comprising 450mg Atrigel and 50mg doxycycline. Two units would be sufficient to treat an entire set of teeth.

Atrix will be promoted as an alternative to the standard therapy for periodontitis, scaling and root planing. The company said the labeling for the product will not be able to say that it is superior to SRP, but will carry a standard statement that it fulfills the regulatory requirement of being at least 75% as good as SRP for periodontitis. However, the company can include the absolute values on the efficacy endpoints from the trials, as well as a pictorial representation which will show the relative merits of the two treatment regimens.