Advancis Completes Enrollment in Adult/Adolescent Amoxicillin PULSYS Trial
Advancis Pharmaceutical has enrolled 504 adult/adolescent patients in the company's Amoxicillin PULSYS Phase III clinical trial for the treatment of pharyngitis/tonsillitis from Group A streptococcal infections.
Advancis' adult and adolescent pivotal program is designed as a 500-patient, double-blind, double-dummy, noninferiority Phase III trial and began Oct. 15, 2004.
Over the coming weeks, patients will complete their treatment and follow-up visits, and Advancis and its clinical research organization will collect and analyze the clinical data. The company expects to publicly report top-line results on or around mid-June 2005.
Advancis also announced that it has enrolled a total of 421 pediatric patients to date in its Amoxicillin PULSYS Phase III trial for the treatment of pediatric patients with acute pharyngitis/tonsillitis. This 500-patient, investigator-blind, noninferiority Phase III trial for a "sprinkle" formulation of Amoxicillin PULSYS is being conducted in 75 investigator sites across the country and began Jan. 5.
The company now expects to conclude this second Phase III trial in April and to announce its top-line results in July 2005. If the trials are successful, Advancis expects to file separate 505(b)(2) new drug applications with the FDA for each product in the fourth quarter of 2005.