WALTHAM, Mass., April 28, 2014 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (Nasdaq:AMAG) today announced that the publication of data from a multi-institutional trial of MuGard has been featured in the print edition of the journal Cancer, available today. MuGard is a mucoadhesive hydrogel that forms a protective coating over the oral mucosa. The randomized, double-blind, placebo-controlled trial showed MuGard was more effective than a sham-control in significantly reducing the mouth and throat soreness 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. 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 Stephen T. Sonis, DMD, DMSc, an expert on cancer treatment complications, Clinical Professor of Oral Medicine at Harvard and the primary author of the protocol for this trial. "This rigorous clinical trial design sets a new standard for evidence supporting the use of agents in this class."
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. Robert Kaper, senior vice president of medical and scientific affairs at AMAG Pharmaceuticals, the company that markets MuGard in the U.S. "AMAG is committed to educating patients and health care providers about the seriousness of oral mucositis and the role MuGard can play in managing the condition."
This study was supported by Access Pharmaceuticals, Inc.
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 $18,000.
About MuGard
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 U.S. Food and Drug Administration.
About AMAG
AMAG Pharmaceuticals, Inc. is a specialty pharmaceutical company that markets Feraheme® and MuGard® in the United States. Along with driving organic growth of its products, AMAG intends to expand its portfolio with additional commercial-stage specialty products. The company is seeking complementary products that leverage the company's commercial footprint and focus on hematology and oncology centers and hospital infusion centers. For additional company information, please visit www.amagpharma.com.
Forward‐looking Statements
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 FDA review of post-marketing safety data, including reports of serious anaphylaxis, cardiovascular events, and death, the FDA will request additional technical or scientific information, new studies or reanalysis of existing data, on-label warnings, post-marketing requirements/commitments or risk evaluation and mitigation strategies (REMS) in the current CKD indication for Feraheme, (3) uncertainties regarding AMAG's and Takeda Pharmaceutical's ability to successfully compete in the intravenous iron replacement market both in the U.S. and outside the U.S., including the EU, as a result of limitations, restrictions or warnings in Feraheme's/Rienso's current or future label that put Feraheme/Rienso at a competitive disadvantage (ferumoxytol is marketed in the EU by Takeda as Rienso™), (4) uncertainties regarding Takeda's ability to obtain regulatory approval for Feraheme in Canada, and Rienso in the EU, in the broader IDA patient population, (5) the possibility that significant safety or drug interaction problems could arise with respect to Feraheme/Rienso and in turn affect sales, or AMAG's ability to market the product both in the U.S. and outside of the U.S., including the EU, (6) uncertainties regarding the manufacture of Feraheme/Rienso or MuGard, (7) uncertainties relating to AMAG's patents and proprietary rights, both in the U.S. and outside of the U.S., (8) the risk of an Abbreviated New Drug Application (ANDA) filing following the FDA's recently published draft bioequivalence recommendation for ferumoxytol, and (9) other risks identified in our Securities and Exchange Commission filings, including our Annual Report on Form 10-K for the year ended December 31, 2013 and subsequent filings with the SEC. AMAG cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made.
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 and Feraheme are registered trademarks of AMAG Pharmaceuticals, Inc.; MuGard is a registered trademark of Access Pharmaceuticals, Inc. Rienso is a trademark of Takeda Pharmaceutical Company Limited.