Evaluated in a multicenter, randomized, double-blind, controlled trial1
To download this study for MuGard, please click here.
Multicentered, randomized, double-blind, controlled trial in patients being treated with chemoradiation for cancers of the head and neck1
- Conventional course of external beam irradiation (single daily fractions of 2.0 Gy to 2.2 Gy) with a cumulative dose of 50 Gy to 72 Gy1
- Concomitant cisplatin was administered weekly or triweekly1
* Flavored saline bicarbonate rinse indistinguishable from MuGard in appearance and identically bottled and labeled.1
Primary efficacy end point
Assessment of the reduction in patients’ mouth and throat soreness associated with OM.1 Significant mouth and throat soreness measured by patient-reported Oral Mucositis Daily Questionnaire (OMDQ) mouth and throat soreness question 2 scores of > 2 was previously described to align with severe mucositis.1
OMDQ mouth and throat soreness question 23
Gives you the confidence of proven efficacy1
In a clinical trial, MuGard significantly reduced mouth and throat soreness compared with saline bicarbonate rinse (control)1,4,a
|ANOVA: analysis of variance; AUC: area under the curve; ITT: intent to treat; OMDQ: Oral Mucositis Daily Questionnaire; SEM: standard error of the mean; SD, standard deviation
||Safety was evaluated in a 7-week study in the ITT population (N = 120) undergoing radiation therapy for head and neck cancer who received study rinse, regardless of the duration of dosing (equal numbers received MuGard and saline bicarbonate rinse). Efficacy was evaluated in the cohort of subjects who received at least 1 dose of study rinse during the first 2.5 weeks following the start of radiation therapy (n = 78: MuGard = 37, control = 41). The primary efficacy end point was reduction in symptoms of OM determined by the AUC of OMDQ mouth and throat soreness question 2.1
The AUC of OMDQ mouth and throat soreness question 2 for the two cohorts was evaluated by ANOVA with factors for treatment and initial OMDQ mouth and throat soreness score.1
In a controlled clinical trial of MuGard, no significant adverse events were reported1
The overall incidence of unanticipated adverse device effects was similar in the MuGard (8%) and control (12%) groups.1
- No patients discontinued MuGard because of unanticipated adverse device effects; however, 2 subjects in the saline bicarbonate rinse group discontinued due to nausea or vomiting1
Indication and Important Safety Information
Indication: MuGard® Oral Mucoadhesive 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.
Contraindications: MuGard is contraindicated in patients with known hypersensitivity to any of the ingredients in the formulation.
Special Precautions for Use: Patients should avoid eating or drinking for at least one hour after using MuGard. After use, patients should replace the bottle cap and tightly seal the bottle. This product should not be used after the expiration date shown on the carton and product label. Do not use this product in patients with known sensitivity to any of the product’s ingredients. Dilution of the product prior to use is not recommended.
You may report an adverse event related to AMAG Pharmaceuticals’ products by calling 1-877-411-2510 or emailing firstname.lastname@example.org. If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly at fda.gov/medwatch or call 1-800-FDA-1088.
Please see full Prescribing Information.
References: 1. Allison RR, Ambrad AA, Arshoun Y, et al. Multi-institutional, randomized, double-blind, placebo-controlled trial to assess the efficacy of a mucoadhesive hydrogel (MuGard) in mitigating oral mucositis symptoms in patients being treated with chemoradiation therapy for cancers of the head and neck. Cancer. 2014;120(9):1433-1440. 2. MuGard [package insert]. Dallas, TX: PlasmaTech Biopharmaceuticals, Inc; 2014. 3. Stiff PJ, Erder H, Bensinger WI, et al. Reliability and validity of a patient self-administered daily questionnaire to assess impact of oral mucositis (OM) on pain and daily functioning in patients undergoing autologous hematopoietic stem cell transplantation (HSCT). Bone Marrow Transplant. 2006;37(4):393-401. 4. Data on file, AMAG Pharmaceuticals, Inc.