What types of studies were conducted with OraVerse?
A. Multicenter, double-blinded, randomized, controlled clinical trials were conducted involving dental patients aged 4 through 92. Maxillary and mandibular trials were conducted in adolescent and adult dental patients who had restorative or periodontal maintenance procedures and who had received one of four leading anesthetics that contained a vasoconstrictor. In a pediatric trial, patients aged 4-11 were studied. A subset of 115 patients, aged 6-11, were included in the efficacy evaluation. OraVerse is not recommended for use in children less than 6 years of age or weighing less than 15 kg (33 lbs).
