FDA Approves MiddleBrook's Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents ... (evaluate its MOXATAGproduct candidate fo...)

FDA Approves MiddleBrook's Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults

Date:1/24/2008

evaluate its MOXATAG product candidate for pediatric patients less than 12 years of age with pharyngitis and/or tonsillitis as part of a post-marketing commitment. The Company has agreed to submit a completed study report and data set for MOXATAG in pediatric patients less than 12 years old within the next five years as part of this commitment.

"Compared to four times daily penicillin, once-daily MOXATAG has shown comparable efficacy and tolerability in eradicating Group A streptococcal infections of the pharynx. However, the once-daily dosing of MOXATAG is a major advantage," said lead study investigator Stan L. Block, M.D., professor of clinical pediatrics at the Universities of Louisville and Kentucky Medical Schools. "For the first time, physicians in the U.S. have the option of an FDA-approved once-daily amoxicillin therapy to treat their adolescent and adult patients with pharyngitis/tonsillitis. This should ensure better first- line therapy compliance with a penicillin class of antibiotic."

Clinical Trial Results Summary

The approval of MOXATAG was based on MiddleBrook's Phase 3 clinical study of more than 600 adults and pediatric patients 12 years and older in a double- blind, double-dummy, randomized, parallel-group, 50-center non-inferiority trial. The Company compared its MOXATAG tablet for the treatment of pharyngitis/tonsillitis due to Streptococcus pyogenes (Group A streptococcus) delivered in a once-daily, 775 milligram tablet for a period of 10 days to 250 milligrams of penicillin dosed four times daily, for a total of one gram per day, for 10 days.

Bacteriological eradication at the post-therapy test-of-cure visit in the per-protocol population was 85.0 percent (198/233) of patients with MOXATAG and 83.4 percent (191/229) with penicillin. These results demonstrate statistical non-inferiority (95 percent confidence interval of -5.1, 8.2). The per-protocol patient population included patients with confirmed Group A strepto
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FDA Approves MiddleBrook's Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents ...(evaluate its MOXATAGproduct candidate fo...),Health