5% amlexanox oral paste, a new treatment for recurrent minor aphthous ulcers: II. Pharmacokinetics and demonstration of clinical safety.

Abstract

The safety of 5% Amlexanox paste was demonstrated in the following clinical studies: vehicle-controlled safety and efficacy studies; dermal irritation and sensitization studies; single and multiple dose pharmacokinetic studies; and a 28-day in use safety study. Minimal adverse experiences were observed with the 991 subjects that were exposed to 5% Amlexanox paste. No significant irritation or sensitization was associated with 5% Amlexanox paste. Pharmacokinetic studies indicated that systemic levels of Amlexanox are most likely due to normal gastrointestinal absorption with only limited absorption directly through the ulcer. After a 100 mg dose of 5% Amlexanox paste the average maximum concentration of Amlexanox in the serum was 120 ng/ml, occurring 2.4 hours after application. The half-life for elimination of Amlexanox was 3.5 hours, and there was no evidence of accumulation with multiple applications. Overall, the data indicate that 5% Amlexanox paste (Aphthasol) is safe for the treatment of recurrent minor aphthous ulcers.

• Authors: A Khandwala, R G Van Inwegen, M R Charney, M C Alfano
• Journal: Oral surgery, oral medicine, oral pathology, oral radiology, and endodontics (Oral Surg Oral Med Oral Pathol Oral Radiol Endod) Vol. 83 Issue 2 Pg. 231-8 (Feb 1997) ISSN: 1079-2104 [Print] United States
• PMID: 9117755 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Aminopyridines
• Anti-Inflammatory Agents
• amlexanox

Topics

• Administration, Topical
• Adult
• Aminopyridines (adverse effects, blood, pharmacokinetics, therapeutic use)
• Anti-Inflammatory Agents (adverse effects, blood, pharmacokinetics, therapeutic use)
• Area Under Curve
• Dose-Response Relationship, Drug
• Drug Evaluation
• Female
• Humans
• Intestinal Absorption
• Logistic Models
• Male
• Metabolic Clearance Rate
• Patch Tests
• Safety
• Skin (drug effects)
• Stomatitis, Aphthous (drug therapy)