In a randomized, double-blind, multicenter, non-inferiority trial*…
• The most common drug-related treatment-emergent adverse reactions for MOXATAG were vulvovaginal mycotic infection (2%), diarrhea (1.7%), nausea (1.3%), headache (1%), vomiting (0.7%), and abdominal pain (0.3%)1
• Discontinuation rates: MOXATAG, 1.3%; penicillin VK, 3.3%
* ITT safety population in a randomized, double-blind, multicenter, non-inferiority trial with MOXATAG involving adult and pediatric patients (≥12 years of age) with tonsillitis/pharyngitis secondary to S. pyogenes (n=302 for MOXATAG; n=306 for penicillin VK). Incidence rates may not reflect the rates observed in practice.
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.