Enrollment In Amoxicillin PULSYS Phase III Trial Completed
Advancis Pharmaceutical Corporation (Nasdaq: AVNC), a pharmaceutical company focused on developing and commercializing novel anti-infective products, today announced that it has completed enrollment in the Company's Amoxicillin PULSYS Phase III clinical trial for the treatment of pharyngitis/tonsillitis due to Group A streptococcal infections. Advancis concluded enrollment with a total of 620 adult/adolescent patients as of close-of-business May 31, 2006.
Advancis' adult and adolescent pivotal program is designed as a 600- patient, double-blind, double-dummy, non-inferiority Phase III trial and began on November 9, 2005. 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 around mid-August 2006. If the trial is successful, Advancis expects to file a 505(b)(2) New Drug Application (NDA) with the U.S. Food and Drug Administration for the product early in the first quarter of 2007.
"We are very pleased to have completed enrollment in our adult and adolescent Phase III trial on schedule," said Edward M. Rudnic, Ph.D., Advancis president and CEO. "We are hopeful that, if successful, Amoxicillin PULSYS will provide physicians a tool to deliver the established safety and efficacy of amoxicillin in the first and only once-daily presentation in the U.S."
Advancis is comparing its Amoxicillin PULSYS dosage form for the treatment of pharyngitis/tonsillitis in adults 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. The primary endpoint for the study is bacterial eradication, as measured by throat cultures obtained both before and after treatment.
More than 59 million prescriptions for Amoxicillin were written in 2005 with total retail sales of approximately $640 million. Amoxicillin is indicated for a broad range of infections, and is commonly prescribed as a first-line therapy for common infections such as otitis media (middle ear infection), pharyngitis (sore throat), and sinusitis (sinus infection). According to data from IMS Health, a pharmaceutical research company, approximately one-quarter of amoxicillin prescriptions are written for pharyngitis, strep throat, and tonsillitis in adults and children.
Advancis Pharmaceutical Corporation
Advancis' adult and adolescent pivotal program is designed as a 600- patient, double-blind, double-dummy, non-inferiority Phase III trial and began on November 9, 2005. 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 around mid-August 2006. If the trial is successful, Advancis expects to file a 505(b)(2) New Drug Application (NDA) with the U.S. Food and Drug Administration for the product early in the first quarter of 2007.
"We are very pleased to have completed enrollment in our adult and adolescent Phase III trial on schedule," said Edward M. Rudnic, Ph.D., Advancis president and CEO. "We are hopeful that, if successful, Amoxicillin PULSYS will provide physicians a tool to deliver the established safety and efficacy of amoxicillin in the first and only once-daily presentation in the U.S."
Advancis is comparing its Amoxicillin PULSYS dosage form for the treatment of pharyngitis/tonsillitis in adults 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. The primary endpoint for the study is bacterial eradication, as measured by throat cultures obtained both before and after treatment.
More than 59 million prescriptions for Amoxicillin were written in 2005 with total retail sales of approximately $640 million. Amoxicillin is indicated for a broad range of infections, and is commonly prescribed as a first-line therapy for common infections such as otitis media (middle ear infection), pharyngitis (sore throat), and sinusitis (sinus infection). According to data from IMS Health, a pharmaceutical research company, approximately one-quarter of amoxicillin prescriptions are written for pharyngitis, strep throat, and tonsillitis in adults and children.
Advancis Pharmaceutical Corporation
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