Access Pharmaceuticals' MuGard was developed to provide a drug delivery vehicle to coat the oral mucosa. MuGard may be used without a drug, or by adding a pharmaceutically-active material to the formulation, to treat mucocutaneous diseases and disorders of the oral cavity.

Access Pharmaceuticals has focused on the use of MuGard in the prevention and treatment of mucositis. MuGard was originally developed as a vehicle for an anti-allergic /anti-inflammatory compound. Access conducted a clinical study in patients at high risk of mucositis (cancer patients receiving radiation to the head and neck region) to determine whether the compound could be beneficial in preventing and treating this condition.

The control was MuGard without the drug. While the outcome of the study showed that the compound in MuGard was no better than MuGard alone, many centers reported that patients were benefiting from the rinse.

As a result, Access performed a statistical analysis of study data with matched controls. This retrospective analysis showed that MuGard significantly improved outcome compared with patients on standard care. Access is currently preparing a 510(k) application for marketing approval of MuGard in the United States.

Approval is anticipated in the second half of 2006. Access is seeking a marketing partner for this product. In addition to its use as a device in the management of mucositis, another potential application of MuGard is in topical drug delivery, where the drug formulated in MuGard is either targeted to the mucosa, or for passage through the mucosa for systemic absorption. Access has conducted proof-of-principle studies in an in vitro model.

One patent application

Licensing and/or co-development