MuGard is a mucoadhesive hydrogel. The randomized, double-blind, placebo-controlled trial showed MuGard was more effective than a sham-control in significantly reducing pain associated with oral mucositis, a common and debilitating side effect of radiotherapy used to treat patients with head and neck cancer.
Of 120 patients participating in the trial, 60 received MuGard and 60 received saline-bicarbonate rinse as a sham-control. The study’s primary endpoint was a reduction in mouth and throat soreness as assessed daily by a validated patient questionnaire.
Compared to control patients, MuGard-treated patients had significantly less mouth and throat soreness. On the last day of radiation therapy, a physician-based assessment found that MuGard-treated patients were significantly less likely to have ulcerative oral mucositis (43%) than those patients treated with the saline-bicarbonate control (68%).
No difference in adverse events was observed between patients receiving MuGard and those patients receiving the saline-bicarbonate control. No patients discontinued MuGard treatment because of an adverse event while two patients using the sham-control ended their medication use due to nausea or vomiting.
AMAG Pharmaceuticals medical and scientific affairs senior vice president Dr Robert Kaper noted this research demonstrates that MuGard is effective in reducing the pain associated with oral mucositis, a serious and common side effect of radiation therapy in cancer patients.
"AMAG is committed to educating patients and health care providers about the seriousness of this condition and the role MuGard can play in reducing the pain and suffering associated with it," Dr Kaper added.
This study was supported by Access Pharmaceuticals.