AMLEXANOX
Place in Therapy
The literature supports the use of amlexanox 5% (in a variety of formulations) for the treatment and prevention of recurrent oral aphthous ulcers.
A relatively large number of well-designed clinical trials consistently support the efficacy and safety of amlexanox over the last twenty years (1,2,3). Amlexanox has been shown to reduce ulcer size, promote healing, result in lower patient-rated pain score, and prevent the progression of prodromal aphthous ulcers (3,4,5). Reviews of treatment for recurrent oral aphthous ulcers suggest that amlexanox be considered as a first-line (3) or second-line option (5). In one trial, amlexanox was comparable in efficacy to a clobetasol topical preparation (2). Unfortunately, the lack of product availability in Canada, cost, and need for a prescription may limit its use (6,7,8).
The safety and efficacy of amlexanox has not been established in children (8). The safety of amlexanox has not been established in patients who are pregnant or breastfeeding (8). Patients should not use amlexanox if they have had a hypersensitivity reaction to amlexanox or any other component of the formulation (8).
References:
1. Greer RO, Lindenmuth JE, Juarez T, Khandwala A. A double-blind study of topically applied 5% amlexanox in the treatment of aphthous ulcers. J Oral Maxillofac Surg. 1993;S1:243-8.
2, Rodriguez M, Rubio JA, Sanchez R. Effectiveness of two oral pastes for the treatment of recurrent aphthous stomatitis.Oral Dis. 2007;13:490-4.
3. Bailey J, McCarthy C, Smith FR, Smith PC. What is the most effective way to treat recurrent canker sores? J Fam Pract. 2011;60(10):621-3.
4. Bell J. Amlexanox for the treatment of recurrent aphthous ulcers. Clin Drug Invest. 2005:25(9):555-66.
5. Elad S, Epstein JB, von Bültzingslöwen I, Drucker S, Tzach R, Yarom N. Topical immunomodulators for management of oral mucosal conditions, a systematic review; part II: miscellaneous agents. Expert Opin Emerging Drugs. 2011;16(1):183-202.
6. NAPRA- Search National Product Schedule. Amlexanox. 2013 [cited 2013 July 14]. Available from: http://napra.ca/pages/Schedules/Search.aspx
7. Health Canada- Drug Products Database. Amlexanox. 2013 [cited 2013 July 14]. Available from: http://webprod5.hc-sc.gc.ca/dpd-bdpp/dispatch-repartition.do?lang=eng
8. Lexicomp Online [Internet]. Amlexanox. 2013 [cited 2013 July 14]. Available from: http://online.lexi.com
A relatively large number of well-designed clinical trials consistently support the efficacy and safety of amlexanox over the last twenty years (1,2,3). Amlexanox has been shown to reduce ulcer size, promote healing, result in lower patient-rated pain score, and prevent the progression of prodromal aphthous ulcers (3,4,5). Reviews of treatment for recurrent oral aphthous ulcers suggest that amlexanox be considered as a first-line (3) or second-line option (5). In one trial, amlexanox was comparable in efficacy to a clobetasol topical preparation (2). Unfortunately, the lack of product availability in Canada, cost, and need for a prescription may limit its use (6,7,8).
The safety and efficacy of amlexanox has not been established in children (8). The safety of amlexanox has not been established in patients who are pregnant or breastfeeding (8). Patients should not use amlexanox if they have had a hypersensitivity reaction to amlexanox or any other component of the formulation (8).
References:
1. Greer RO, Lindenmuth JE, Juarez T, Khandwala A. A double-blind study of topically applied 5% amlexanox in the treatment of aphthous ulcers. J Oral Maxillofac Surg. 1993;S1:243-8.
2, Rodriguez M, Rubio JA, Sanchez R. Effectiveness of two oral pastes for the treatment of recurrent aphthous stomatitis.Oral Dis. 2007;13:490-4.
3. Bailey J, McCarthy C, Smith FR, Smith PC. What is the most effective way to treat recurrent canker sores? J Fam Pract. 2011;60(10):621-3.
4. Bell J. Amlexanox for the treatment of recurrent aphthous ulcers. Clin Drug Invest. 2005:25(9):555-66.
5. Elad S, Epstein JB, von Bültzingslöwen I, Drucker S, Tzach R, Yarom N. Topical immunomodulators for management of oral mucosal conditions, a systematic review; part II: miscellaneous agents. Expert Opin Emerging Drugs. 2011;16(1):183-202.
6. NAPRA- Search National Product Schedule. Amlexanox. 2013 [cited 2013 July 14]. Available from: http://napra.ca/pages/Schedules/Search.aspx
7. Health Canada- Drug Products Database. Amlexanox. 2013 [cited 2013 July 14]. Available from: http://webprod5.hc-sc.gc.ca/dpd-bdpp/dispatch-repartition.do?lang=eng
8. Lexicomp Online [Internet]. Amlexanox. 2013 [cited 2013 July 14]. Available from: http://online.lexi.com