Advancis files NDA for strep-throat pill

GERMANTOWN, Md., Dec. 15 (UPI) -- Advancis said Friday it filed a new drug application with the U.S. Food and Drug Administration for Amoxicillin Pulsys for strep throat.

The antibiotic combination, which is given once daily, is intended to provide a lower treatment dose alternative to current approved penicillin and amoxicillin regimens for strep throat.

"We are proud to have completed our first NDA for a proprietary Pulsys product, and if approved, we believe Amoxicillin Pulsys would offer physicians and patients a major advance in the most commonly prescribed antibiotic in the United States," said Dr. Edward Rudnic, Advancis' president and chief executive officer.

The company said its phase 3 study of Amoxicillin Pulsys involving 620 adults and adolescents with strep throat met its primary and secondary endpoints. In that trial, patients received a once-daily 775 milligram tablet of Amoxicillin Pulsys for 10 days compared to the standard therapy of 250 milligrams of penicillin VK dosed four times daily, for a total of one gram per day.