Five percent Amlexanox oral paste is a novel treatment for aphthous ulcers. In 3 controlled clinical studies that evaluated 1,124 immunocompetent patients with mild to moderate aphthous ulcers, 5% Amlexanox oral paste (Aphthasol) was shown to accelerate healing of these ulcers. Treatment with Aphthasol reduced the median time to ulcer healing and to complete pain resolution in a statistically significant manner. This was true both when treatment with 5% Amlexanox oral paste was compared to treatment with a vehicle and when treatment with the Amlexanox paste was compared to no treatment. Study results after 3 days comparing treatment with the paste and no treatment indicated complete healing of ulcers for 21% and 8% of patients, respectively. Complete resolution of pain after 3 days was reported for 44% and 20% of patients, respectively.