MuGard

Fact Sheet

What is oral mucositis?

Oral mucositis is a frequent complication of cancer chemotherapy or of radiation therapy to the head and neck region. Currently available products are usually inadequate, and more effective treatment to minimize the extent and duration of mucositis is clearly needed. Historically, treatment of mucositis has been palliative and aimed at minimizing mucosal trauma. Treatments include frequent mouth cleansing and rinsing with buffered saline and fluoride solutions and administration of topical and systemic antimicrobial agents. Mucositis and infection of the mouth have remained major complications despite the usual oral care provided for patients with cancer.

What is MuGard?

MuGard is a viscous, mucoadhesive rinse which provides a protective coating to the oral mucosa. In a comparison of patients undergoing standard care with patients using MuGard, the incidence and severity of mucositis was significantly lower for the MuGard group. MuGard has received marketing allowance in the United States under a 510(k) from the Food and Drug Administration.

Clinical Trials of MuGard

Access has conducted a clinical trial of MuGard, the results of which were compared to historical data from two different sources for patients at risk of developing mucositis and who had received prior standard of care treatment. (Cancer; 1999, 85 (10): 2103-2113, and Cancer; 2000, 89 (11): 2258-2265). In both cases, it was shown mucositis scores, as measured by the oral mucositis assessment scale (OMAS), were lower for patients using MuGard than for similar patients on standard care.

Clinical Data

The clinical results for MuGard are shown in the following graph. This displays the average mucositis score (OMAS scale; 0=no mucositis, 5=severe mucositis) for patients during 28 weeks of radiation therapy for head and neck cancer. The patients using MuGard (red line) starting using MuGard on the first day of therapy and continued using the product throughout their cancer treatment. Retrospectively, MuGard results were compared with a very similar patient population that were on standard care for mucositis. As can be seen on the graph, their average mucositis score was much greater than that for MuGard.

Management of mucositis

One of the most striking features of a comparison of MuGard to standard of care is that 43% of patients on MuGard experienced no mucositis (OMAS score never exceeded 0.5) compared with only 7% in the historical control group

These data were the basis for Access’ 510(k) application for marketing allowance for MuGard.

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