In a randomized, double-blind, multicenter, non-inferiority trial with MOXATAG involving adult and pediatric patients (≥12 years of age)…
• MOXATAG 775 mg once-daily achieved efficacy similar to that seen with penicillin VK 250 mg 4 times daily for 10 days in patients with tonsillitis/pharyngitis secondary to S. pyogenes1
Bacteriologic eradication rates were assessed at a test-of-cure (TOC) visit (Days 14 to 18).
• In the per-protocol bacteriologic (PPb) population, MOXATAG achieved bacterial eradication rates of 85.0% vs 83.4% with penicillin VK; rate difference 95% CI (%): 1.6 (-5.1, 8.2)1
— The per-protocol population included modified intent-to treat (mITT) patients who had post-therapy cultures, were compliant with treatment, and did not have major protocol violations
References: 1. MOXATAG [package insert]. Berwyn, PA: Vernalis Therapeutics, Inc; 2016. 2. Orange Book: Approved drug products with therapeutic equivalence evaluations. US Food and Drug Administration website. http://www.accessdata.fda.gov/scripts/cder/ob/. Accessed July 8, 2016.