The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved December 1997

Specific Treatments:

canker sores

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General Information

A new prescription medication is now available to dentists and physicians to provide help to millions of canker sore sufferers in the U.S. Aphthasol (amlexanox oral paste, 5%), the first and only prescription medication indicated specifically for the treatment of canker sores, has been approved in patients with normal immune systems. Aphthasol is available in 5 gram tubes.

Clinical Results

Aphthasol was proven safe and effective when used as directed in four clinical trials with more than 1,300 patients. The most common adverse effects, as reported by 1-2% of patients, were transient pain, burning, and/or stinging sensations at the site of application. Clinical data confirms that best results from Aphthasol occur with earliest possible use.