Access Pharmaceuticals, Inc. announced that it has been notified by the US FDA that its New Drug Application (NDA) for OraDisc has successfully completed the initial review. This initial review, generally known as the completeness review, assesses whether the NDA contains all necessary data and information required for filing. The NDA will now proceed to its formal review by the dermatological division of the FDA.

Kerry Gray, Access CEO commented, "We are delighted to receive this news from the agency. The NDA was submitted early in December in the common technical document (CTD) format. We chose to use this new format as it is being adopted by regulatory agencies around the world, and should allow for faster worldwide registration compared to the previous dossier format, when registration documents had to be re-formatted for each regulatory body."

OraDisc is an improved delivery system for amlexanox, the active ingredient in Access' product Aphthasol, which is approved for the treatment of canker sores. The OraDisc technology is a proprietary mucoadhesive patch which gradually erodes and releases an active ingredient when applied to the inside of the mouth. Access is developing several other products based upon this technology, and recently announced a collaboration with a major pharmaceutical company to develop a product utilizing the OraDisc technology.

Numerous clinical studies have shown that Aphthasol and OraDisc accelerate the healing of canker sores. When applied during the pre- ulcerative stage of the disease, clinical studies have also shown that these products significantly reduce the incidence of ulcer formation.

Gray continued, "We have been delighted by the positive response to OraDisc we have had from clinical trial centers. Data gathered from clinical trial participants is very positive for perceived effectiveness and ease of application, and there is also a very strong purchase intent."