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. Efficacy was assessed in the 78 patients who received at least 1 dose of study rinse within 2.5 weeks of starting radiation therapy. Compared to control patients, MuGard-treated patients had significantly less mouth and throat soreness over the course of the study (p=0.034). On the last day of radiation therapy, a physician-based assessment found that significantly fewer MuGard-treated patients had ulcerative oral mucositis than those patients treated with the saline-bicarbonate control (43% vs. 68%; p=0.038).
“Oral mucositis continues to be a significant unmet medical need with symptomatic consequences, and this multi-institutional study provides strong evidence of MuGard’s effectiveness in mitigating the symptoms of oral mucositis,” said
No difference in adverse effects was observed between patients receiving MuGard and those patients receiving the saline-bicarbonate control. No patients discontinued MuGard because of an adverse effect while two patients using the sham-control discontinued due to nausea or vomiting.
“This research demonstrates that MuGard is effective in managing oral mucositis, a serious and common side effect of radiation therapy in cancer patients,” said Dr.
This study was supported by
About Oral Mucositis
Oral mucositis is a painful inflammation and ulceration of the lining of the mouth. It is a common side effect of many of the radiotherapy and chemotherapy regimens used to treat cancer and affects almost 400,000 patients in the U.S. Its presence creates a significant burden of illness for cancer patients and is associated with weight loss, increased narcotic use, unplanned visits to physicians or the emergency room and hospital admission. The incremental cost of oral mucositis in patients with head and neck cancer is approximately
MuGard® Mucoadhesive Oral Wound Rinse is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces. MuGard is contraindicated in patients with known hypersensitivity to any of the ingredients in the formulation. MuGard was launched in 2010 after receiving 510(k) clearance from the
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including but not limited to statements regarding: the effectiveness of MuGard, AMAG’s plans to educate patients and health care providers regarding oral mucositis and MuGard and AMAG’s plans to seek complementary commercial products to add to its portfolio are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements.
Such risks and uncertainties include, among others: (1) uncertainties regarding the likelihood and timing of potential approval of AMAG’s sNDA for Feraheme in the U.S. in the broader IDA indication, (2) the possibility that following
AMAG disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
AMAG Pharmaceuticals, Inc. Maryann Cimino, 617-498-3375