Atrix Laboratories submitted a new drug application (NDA) to the FDA for its periodontal disease treatment, Atridox, a sustained-release form of an antibiotic used to kill bacteria that build up around gums and result in detachment of the tissue from teeth.
The Fort Collins, Colo., company's Atridox NDA is supported by two successful Phase III trials that demonstrated the treatment achieved statistical significance compared with a placebo in combating periodontitis and clinical equivalence compared to conventional therapy, which involves scaling and root planing. (See BioWorld Today, Sept. 9, 1996, p.2.)
Atridox combines doxycycline, an FDA-approved antibiotic, with a biodegradable polymer which is placed into infected gums and releases the drug over seven days.
Atrix's stock (NASDAQ:ATRX) closed Tuesday at $11, up $0.125. * Charles Craig