OraDisc A

OraDisc A

Generic Name: amlexanox mucoadhesive patch

Date of Approval: September 29 ,2004

Company: Access Pharmaceuticals, Inc.

Treatment for: Aphthous Ulcers

OraDisc A Approved by FDA

The U.S. Food and Drug Administration (FDA) has approved OraDisc A, an improved delivery system for amlexanox, which has previously been approved by the FDA for the treatment of aphthous ulcers.

The OraDisc technology is a proprietary mucoadhesive patch which gradually erodes and releases an active ingredient when applied to the inside of the mouth.

The approval of this new drug application provides for the use of the amlexanox mucoadhesive patch 2mg for the treatment of aphthous ulcers in adults and adolescents 12 years of age and older with a normal immune system.

In the clinical program undertaken by Access for OraDisc A, pediatric patients 12 years of age and older were included in the studies. This has enabled us to extend the potential use of amlexanox to include patients 12-17 years of age which is considered an important patient group for this indication.

The OraDisc dosage form is designed to be more acceptable to the patient in terms of ease of application, retention over the affected site, taste and its aesthetic qualities.

The advantages of the OraDisc A dosage form are:

More concentrated delivery of amlexanox to the aphthous ulcer

Disc dosage form will limit delivery of amlexanox to a small surface area

OraDisc backing will help to retain the active drug substance at the site of the aphthous ulcer for a longer period.

Utilizing the OraDisc dosage form with amlexanox, it is anticipated that higher concentrations will be achieved at the site of administration and thus, potentially increasing the effectiveness of the product.