ADVANCIS FILES FOR APPROVAL OF ONCE-DAILY AMOXICILLIN

Advancis Pharmaceutical has filed a new drug application (NDA) with the FDA for its once-daily Amoxicillin PULSYS product for the treatment of adolescents and adults with pharyngitis/tonsillitis via the 505(b)(2) regulatory pathway.

The FDA is expected to determine within 60 days whether the submission is acceptable for filing. Should the FDA accept the application for filing, the company expects to receive a Prescription Drug User Fee Act action date of 10 months from the date of filing.

In August Advancis announced that the its Phase III trial for the treatment of acute pharyngitis/tonsillitis in 620 adults and adolescent patients due to Group A streptococcal infections successfully met its primary and secondary endpoints. Amoxicillin PULSYS dosage form for the treatment of pharyngitis was delivered in a once-daily 775-mg tablet for 10 days, versus the standard comparator therapy of 250 mg of penicillin VK dosed four times daily for 10 days.

Advancis' Amoxicillin PULSYS is a once-a-day pulsatile-release formulation of amoxicillin for oral administration. Amoxicillin PULSYS is intended to provide a lower-dose, once-daily alternative to currently approved penicillin and amoxicillin regimens for the treatment of adults and adolescents with tonsillitis and/or pharyngitis.