Products / MuGard®

MuGard® is a ready-to-use mucoadhesive oral rinse. The mucoadhesive formulation forms a protective coating over the oral mucosa when washed around the mouth. The product has been developed mainly for the prevention and treatment of oral mucositis that may be caused by radiotherapy and/or chemotherapy.

MuGard® is Access Pharmaceuticals’ proprietary product. SpePharm is responsible for manufacturing and commercializing MuGard® throughout Europe.

Oral mucositis

Oral mucositis is a frequent complication of cancer chemotherapy, or of radiation therapy to the head and neck region. Up to 40% of all patients receiving chemotherapy and/or radiotherapy develop moderate to severe mucositis, and almost all patients receiving radiotherapy for head and neck cancer, and those undergoing stem cell transplantation develop mucositis.

Historically, treatment of mucositis has been palliative and aimed at minimizing mucosal trauma. Mucositis and infections of the mouth have remained major complications despite the usual oral care provided for patients with cancer such as improved dental hygiene, rinsing with buffered saline (with or without fluoride solutions), and the administration of topical antiseptic/antimicrobial agents.

Updated clinical practice guidelines for the prevention and treatment of mucositis recommend the use of a preventive oral care regimen as part of routine supportive care along with a therapeutic oral care regimen if mucositis develops.

Clinical results

MuGard® is designed to achieve its intended action through the presence of a polymer formulation with properties that result in adherence of the hydrated polymer system to the oral mucosa, forming a protective coating. It is advised that treatment with MuGard® be initiated at the beginning of chemotherapy and/or radiotherapy.

In clinical trials, MuGard® was shown to reduce the severity and duration of mucositis in patients when compared with no treatment or standard of care practices. In a study of patients with head and neck cancer undergoing radiation with or without concomitant chemotherapy, the OMAS (Oral Mucositis Assessment Scale) scores of patients treated with MuGard® were compared with matched historical data obtained from two different sources (published in 1999 and 2000). In both cases, it was shown that mean mucositis scores were lower for patients using MuGard® than for similar patients on standard care. More importantly, 42.3% of patients in the MuGard® group did not develop significant mucositis (score never exceeded 0.5) during the 6-7 week radiation treatment cycle compared with only 7% in the historical control group who did not develop significant mucositis.

The results of the analyses demonstrate a clear clinical benefit of using MuGard®, based on OMAS validated and reproducible scoring, in terms of both the incidence of mucositis during the course of radiation therapy and the severity of symptoms.

Regulatory status

In 2008, SpePharm was granted a CE mark certification for MuGard® with the following labelling "prevention and treatment of lesions and symptoms of oral mucositis caused or induced by radiotherapy and/or chemotherapy". MuGard® is a class IIa Medical Device.

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