First prescription drug for severe mouth sores

FDA Consumer, March, 1997

The first prescription treatment for painful, severe canker sores in the mouth in people with normal immunity has been approved by FDA. The medical name for these sores is aphthous ulcers.

The agency approved the drug, Aphthasol (amlexanox oral paste, 5 percent), Dec. 17. In clinical studies, Aphthasol reduced ulcer healing time by a day to a day and a half, compared with a placebo or no treatment. Pain was relieved as the ulcers healed. Some participants reported stinging or burning where the medicine was applied, and, less frequently, nausea and diarrhea.

While people with AIDS acquire especially virulent aphthous ulcers, the new drug's safety and effectiveness in individuals with weakened immunity has not been assessed at this time.

Users should apply Aphthasol paste directly to their ulcers four times a day, following oral hygiene after meals and before bedtime. If the ulcers have not healed in 10 days, patients should visit their dentists or health-care providers.

Aphthasol is manufactured by Block Drug Co. Inc., Jersey City, N.J.