Study Shows MuGard(R) is More Effective Than Sham-Control at Reducing Mouth
and Throat Soreness Associated With Oral Mucositis in Head and Neck Cancer
WALTHAM, Mass., Feb. 18, 2014 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc.
(Nasdaq:AMAG) today announced the publication of data from a
multi-institutional trial of MuGard in the online edition of the journal
Cancer available at
http://onlinelibrary.wiley.com/doi/10.1002/cncr.28553/full. 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%).
"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 and delaying its progression," stated 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 process separates MuGard from currently
available palliative rinses and sets a new standard for evidence-based use of
agents in this class."
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.
"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,"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 this condition and the role MuGard can
play in reducing the pain and suffering associated with it."
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 500,000 patients in the
U.S.Its presence creates a significant burden of illness of 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 was launched in 2010 after receiving
510(k) clearance from the U.S. Food and Drug Administration.
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.
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
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
AMAG Pharmaceuticals and Feraheme are registered trademarks of AMAG
Pharmaceuticals, Inc.; MuGard is a trademark of Access Pharmaceuticals,
Inc.Rienso is a trademark of Takeda Pharmaceutical Company Limited.
CONTACT: AMAG Pharmaceuticals, Inc.
Maryann Cimino, 617-498-3375
AMAG Pharmaceuticals logo
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