Amlexanox was discontinued in the United States due to a lack of commercial viability. While the drug demonstrated efficacy in treating aphthous ulcers (canker sores) and certain inflammatory conditions, its market performance did not justify continued production and distribution by its manufacturer, Lyne Laboratories [1].
When might amlexanox return to the market?
The potential for amlexanox to return to the U.S. market is uncertain. Its discontinuation was primarily a business decision rather than a safety or efficacy concern. A new manufacturer or a renewed commercial interest would be necessary for its reintroduction.
What is amlexanox used for?
Amlexanox is a benzalacetone derivative that functions as an anti-inflammatory agent. It was approved for the treatment of aphthous ulcers, commonly known as canker sores. It has also been explored for other inflammatory conditions [1].
Are there alternatives to amlexanox for canker sores?
Yes, several alternatives are available for managing canker sores. These include over-the-counter topical anesthetics, such as benzocaine or lidocaine, which provide temporary pain relief. Corticosteroid ointments or rinses may also be prescribed to reduce inflammation. Some individuals find relief with hydrogen peroxide rinses or saltwater rinses [2].
What was the mechanism of action for amlexanox?
Amlexanox works by inhibiting various inflammatory mediators. It interferes with the function of neutrophils and eosinophils, and it reduces the production of certain cytokines, such as tumor necrosis factor-alpha (TNF-α) and interleukins [1]. This anti-inflammatory action is believed to be responsible for its therapeutic effects on aphthous ulcers.