The Amoxicillin PULSYS Phase III Trial
achieved its clinical goals in the treatment
of adults and adolescents with
pharyngitis/tonsillitis due to Group A
streptococcal infections (strep throat).
Advancis Pharmaceutical Corp enrolled
620 adults and adolescents in a randomized,
double-blind, multicenter, noninferiority
trial in November 2005. Researchers
compared the once-daily, 775-mg tablet of Amoxicillin PULSYS for 10
days with 250 mg of penicillin VK 4 times
a day for 10 days. The primary desired
end point of the trial was bacterial eradication
at the "test-of-cure" visit for
patients who had completed the protocol,
measured by throat cultures before
and after treatment. Bacterial eradication
at the posttherapy test-of-cure visit
among the patients who had completed
the protocol was 85% in the Amoxicillin
PULSYS group and 83.4% with penicillin.
Stan L. Block, MD, an investigator in the
study and a professor of clinical pediatrics
noted, "The outcomes were
achieved through a single-daily-dose
administration, a significant factor with
the potential to positively impact patient
compliance."
Ms. Farley is a freelance medical
writer based in Wakefield, RI.