First Prescription Treatment for Oral Ulcers

FDA has approved amlexanox oral paste, 5 percent, the first prescription treatment for aphthous ulcers in people with normal immune systems. Aphthous ulcers are painful, severe canker sores in the mouth. FDA based its approval on placebo-controlled clinical trials demonstrating that amlexanox reduced the time for ulcers to heal. In general, patients improved 1 to 1-1/2 days sooner with amlexanox; pain relief was also faster. While people with AIDS do develop especially virulent forms of aphthous ulcers, the safety and effectiveness of this drug in immunocompromised individuals has not been assessed at this time.
The drug is contained in a paste that is applied directly to the ulcers four times a day, following oral hygiene after meals and before bedtime. Health care providers should advise their patients to make a return visit if the ulcers have not healed in 10 days. Some clinical trial participants reported stinging or burning where the medicine was applied and, less frequently, nausea and diarrhea.
Block Drug Company Inc. of Jersey City, New Jersey, manufactures amlexanox under the trade name Aphthasol.

美国FDA批准氨来呫诺作为第一个治疗口腔溃疡药物

　　美国食品药品监督管理局(FDA)批准了氨来呫诺(Amlexanox)5%糊剂，这是FDA批准的第一个治疗口腔溃疡的处方药，用于治疗免疫功能正常的口腔溃疡患者。口腔溃疡（阿弗他溃疡）是发生于口腔的疼痛性，严重溃烂性疾病。FDA批准氨来呫诺作为首个治疗口腔溃疡的药物是基于：临床随机双盲试验，证实氨来呫诺能够促进溃疡的愈合，缩短愈合时间。病人平均缩短愈合时间1—1.5天。疼痛缓解也很迅速。伴有免疫功能异常的爱滋病的口腔溃疡患者，此药的安全性和有效性，本次临床试验未涉及。

　　该药成糊状，直接用于口腔溃疡患处，每天4次。餐后和睡前使用。用药后10日溃疡仍未愈合，应请教医生。部分病人用药后局部有刺感，和烧灼感。少数病人出现恶心及腹泻。

FDA官方网站原文链接

www.fda.gov/medbull/mar97/articles.htm