A Short-term Clinical Evaluation Of Amlexanox Mucoadhesive Tablet In The Manegement Of Minor Aphthous Ulceration-efficacy & Safety

Recurrent aphthous ulceration(RAU)is among the most common oral mucosal lesions in the general population,with a frequency of up to 5%-25% . The ulcers, which usually occur can cause considerable pain and may interfere with eating, speaking, and swallowing. RAU is classified as minor, major, and herpetiform on the basis of ulcer size and number. The causes of RAU include local trauma , stress,systemic diseases , nutritional deficiencies, food allergies, genetic predisposition, immune disorders, infection,et al. Topical medications, such as antimicrobial mouthwashes and topical corticosteroids, can get relief of pain and reduction of ulcer duration,but have not been shown to alter recurrence or remission rates. Systemic medications such as Corticosteroids and immunomodulatory drugs can be tried if topical therapy is ineffective.Amlexanox is a topical anti-infiammatory,antiallergic drug ,which is reported to be associated with inhibition of the release of leukotrienes and histamine.5% Amlexanox oral paste(Aphthasol) has been clinically proven to abort the onset, accelerate healing and resolve the pain of aphthous ulcers. Aphthasol has already get approvement from FDA. Amlexanox Mucoadhesive Tablet is an improved delivery vehicle for amlexanox ,The Mucoadhesive formulations overcome the difficultiesencountered in using conventional paste and gel formulations in the mouth, as these products are difficult to apply and keep in place over time. The tablet adheres to the canker sores and slowly erodes over time, locally releasing amlexanox at the site of the canker sores. Utilizing this technology, we anticipate that higher drug concentrations will be achieved at the disease site, increasing the effectiveness of the product.In order to determine the efficacy and safety of Amlexanox Mucoadhesive Tablet when applied topically for the treatment of minor aphthous ulcerations,A multicenter,unparallel group,randomized, double-blind,vehicle-controlled,clinical study was carried out in 212 subjects.The amlexanox treatment group included 104 subjects(m47,f57) while the vehicle-controlled group included 108 subjects(m54,f54).During the treatment period,which lasted for 5 days ,the tablet was applied by the subjects themselves four times a day.Efficacy was assessed by the following parameters :l)pain measured by Visual Analog Scale(VAS);2)size measured by perpendicular dimensions of the ulcer;3)erythema and exudation. All parameters were measured immediately after day 3 and day 5.Evaluations were based on a comparison with the day 1 visit of the patient .All parameters were analyzed, using SPSS statistical software.Group difference for all parameters were statistically significant ( P <0.05) ,except for erythema and exudation of day 3.Only two minimal adverse experiences were reported,such as sting of the oral mucous and edema of the finger.No systemic effects were reported.Based on these findings,topical amlexanox mucoadhesive tablet is effective and safe in reducing aphthous ulcer pain and lesional size.