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news.Advancis Pharmaceutical's Amoxicillin Pulsys phase III clinical trial for the treatment of adults and adolescents with pharyngitis/tonsillitis due to group A streptococcal infections has achieved its desired microbiological and clinical endpoints.
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Positive trial results were achieved with a once-daily 775mg dose of Amoxicillin Pulsys for 10 days. The most commonly prescribed treatment for the management of group A streptococcal pharyngitis is 500mg of amoxicillin dosed three-times daily for a period of 10 days. Amoxicillin is currently not approved for once-daily dosing to treat pharyngitis.
The trial compared Advancis’ Amoxicillin Pulsys 775mg tablet dosed once-daily for 10 days to 250 milligrams of penicillin VK dosed four times daily for 10 days in adults and adolescents. According to top-line trial data, Amoxicillin Pulsys demonstrated statistical non- inferiority to the comparator therapy in the trial’s primary endpoints – bacterial eradication at the post-therapy ‘test-of-cure’ visit for patients who fully complied with the trial protocol, as well as in a larger patient population.
Bacteriological eradication at the post-therapy test-of-cure visit in the per-protocol population was 85% of patients with Amoxicillin Pulsys and 83.4% with penicillin. These results demonstrate statistical non-inferiority.
Bacteriological eradication at the post-therapy test-of-cure visit in the modified intent-to-treat population was 82.4% of patients with Amoxicillin Pulsys and 78.4% with penicillin. These results also demonstrate statistical non-inferiority.
Amoxicillin Pulsys also demonstrated non-inferiority in the trial’s secondary endpoints, including clinical cure at the test-of-cure visit and bacterial eradication at the late post-therapy visit.
“The positive outcome of this trial provides proof-of-concept that Pulsys antibiotic dosing is effective in eradicating streptococcal bacteria in humans,” stated Edward Rudnic, president and CEO of Advancis. “If approved for marketing, we believe our once-daily version of amoxicillin would represent a major advance in the most widely used antibiotic in the US and would be the first and only once-daily amoxicillin therapy approved for marketing in the US.”