New Data Confirms the Efficacy of NeutraSal in Relieving the Discomfort of Oral Mucositis in Head and Neck Cancer Patients

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New data shows that NeutraSal® (http://www.NeutraSal.com), an advanced electrolyte solution indicated for the treatment of oral mucositis and xerostomia, helps relieve painful oral mucositis (OM) when initiated at the start of chemotherapy or radiotherapy for head and neck cancer patients. The data has been submitted for poster presentation at the upcoming AMERICAN SOCIETY FOR RADIATION ONCOLOGY (ASTRO) Multidisciplinary Head and Neck Cancer Symposium to be held in Arizona in January 2012.

The data confirmed that NeutraSal® is a useful tool to help oncology nurses and other healthcare professionals in the management of OM and related symptoms, particularly in patients with head and neck cancer and those receiving chemotherapy. The research concludes that NeutraSal®, a supersaturated calcium phosphate rinse, should be introduced early in the course of cancer therapy for patients at high risk of oral mucositis, particularly patients undergoing chemo radiation.
The rates of severe oral mucositis (World Health Organization’s Oral Toxicity Score-Grade 3-4) reported by the head and neck cancer patients undergoing radiation therapy using NeutraSal® in this study were 11% (Grade 3) and 0% (Grade 4). Historically, the incidence of severe OM in head and neck cancer patients receiving radiation typically ranges from 34% - 56%, depending upon the specific type of treatment. (Trotti, MD et al: Radiotherapy and Oncology (2003)). Additionally, 54% of the patients undergoing radiation therapy reported Grade 0 OM or no mucositis.

Oncologists at 8 sites enrolled 52 patients into this open-label, non-randomized observational study. Patients must have been beginning chemotherapy and radiation and to be at high risk of developing OM. One hundred percent (100%) of the patients had a diagnosis of head and neck cancer (HNC). All patients in this study received NeutraSal®, administered as an oral rinse, four to 10 times daily for an average of six to eight weeks beginning the first day of treatment. The study showed that 89 percent of the patients undergoing radiotherapy reported favorable OM scores as measured by the percentages of patients indicating Grade 0 (no adverse effects or within normal limits), Grade 1 (mild) or Grade 2 (moderate) symptom severity undergoing radiotherapy. Patients undergoing chemo radiation reported similar scores (80% favorable OM scores indicating Grade 0, Grade 1 or Grade 2).

Patient satisfaction with NeutraSal was very high with 94% of the patients reported satisfied or very satisfied with the product. Treatment interruption was recorded in 4% of the chemo radiation patients and 0% or none in the radiation alone arm. This data confirms that early intervention with NeutraSal reduces the occurrence and severity of OM in patients undergoing radiation or combination therapy treatments for head and neck cancer.

Oral Mucositis: A Common and Debilitating Condition
Mucositis is the painful inflammation and ulceration of the mucous membranes lining the digestive tract, usually as an adverse effect of chemotherapy and radiotherapy treatment for cancer. Mucositis can occur anywhere along the gastrointestinal (GI) tract, but oral mucositis refers to the particular inflammation and ulceration that occurs in the mouth. Oral mucositis is a common and often debilitating complication of cancer treatment. Oral and gastrointestinal (GI) mucositis can affect up to 100% of patients undergoing high-dose chemotherapy and hematopoietic stem cell transplantation (HSCT), and nearly all patients with malignancies of the head and neck receiving radiotherapy, and a wide range of patients receiving chemotherapy. Alimentary tract mucositis increases mortality and morbidity and contributes to rising health care costs

About NEUTRASAL
NeutraSal® is an advanced electrolyte solution indicated in the U.S. as an adjunct to standard oral care in treating OM caused by radiation or high dose chemotherapy. NeutraSal®, a U.S. patent-pending prescription medical device, is also indicated for dryness of the mouth or throat (hyposalivation, xerostomia). For more information about NeutraSal®, visit http://www.NeutraSal.com or contact Invado Pharmaceuticals at (866) 963-8881.

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Edward Kobus
Invado Pharmaceuticals
(866) 963-8881
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