Skip to Content

OraDisc A

Treatment for Aphthous Ulcers

Access’ OraDisc A NDA Accepted For Filing

DALLAS, TEXAS, February 19, 2004 --Access Pharmaceuticals, Inc. (AMEX: AKC) today announced that it has been notified by the FDA that its New Drug Application (NDA) for OraDisc A 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 P. Gray, Access President and 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 reformatted for each regulatory body.”

OraDisc A 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 A 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.

Mr. Gray continued, “We have been delighted by the positive response to OraDisc A 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.”

Access Pharmaceuticals, Inc. is an emerging pharmaceutical company focused on developing both novel low development risk product candidates and technologies with longer-term major product opportunities. Access markets Aphthasol, the only FDA-approved product for the treatment of canker sores, and is developing products for mucositis, and products utilizing its oral delivery, vitamin mediated and nanoparticle delivery systems. Access is also developing unique polymer platinates for use in the treatment of cancer and has developed, in conjunction with its partner Strakan, Ltd., the marketed product Zindaclin, which utilizes ResiDerm, our topical zinc delivery system that provides rapid delivery and reservoir of a drug in the skin.

Source: Access Pharmaceuticals

Posted: February 2004

Related Articles

OraDisc A (amlexanox) FDA Approval History