Aphthasol® 5% Paste (amlexanox)  

Aphthasol® contains 5% amlexanox in an adhesive oral paste. Aphthasol® is FDA approved and indicated for the treatment of aphthous ulcers in people with normal immune systems.

  Aphthasol® 5% Paste (amlexanox)-Advantages:  
  Accelerates healing of Aphthous Ulcer  
  • 39% faster rate of ulcer reduction
  • Shorter median time to treat ulcers
  Accelerates Complete Resolution of Pain  
  Effective for Treatment of Aphthous Ulcers  

The inactive ingredients of the Aphthasol® 5% Paste are all listed on the FDA Inactive Ingredients List and are classified as GRAS (generally regarded as safe).


“The beneficial effect of 5% amlexanox paste to accelerate the healing of aphthous ulcers has been clearly and consistently demonstrated in the four similarly designed vehicle-controlled, studies described in this article."


(Source: Oral Surg, Oral Med, Oral Pathol, Oral Radio Endo. 1997; 83:222-30)


Aphthous Ulcers-The Disease:


Recurrent aphthous ulcers (RAU) or stomatitis (RAS) is characterized by painful, recurring ulcerations of the oral mucosa. It is the most common oral ulcerative disease in human beings yet a principal etiology has yet to be discovered. It is estimated that there are 15 million patients in the USA who suffer from recurrent aphthous ulcers of which 5 million are chronic sufferers. There is a significant body of evidence suggesting an immunologic mechanism as a cause of RAU. Recurrence may be precipitated by trauma, hormonal changes, physical or psychic stress and chemical irritants. Allergy and genetic factors have been associated with the disease. Of those factors which can potentially exacerbate RAU, several studies seem to support the association of minor mucosal trauma with ulcer onset in susceptible individuals. While the specific nature of the disease remains unknown, current evidence suggests aphthous stomatitis is a non-infectious inflammatory mucosal disease. Recurrences can last anywhere from 4 to 30 days, with most episodes lasting 7 to 10 days.




© 2016 ULURU Inc.

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