Tulane University Study Published In The American Journal of Medicine Finds Nutritional Management With Metanx® Benefits Type 2 Diabetes Patients With Neuropathy

Neuropathic total symptoms and quality of life observed significant improvement compared to placebo after 24 weeks

Jan 28, 2013, 08:00 ET from Pamlab, L.L.C.

NEW ORLEANS, Jan. 28, 2013 /PRNewswire/ -- Pamlab L.L.C., developer and marketer of Metanx®, announced today that a multicenter study, done in collaboration with Tulane University, was published in The American Journal of Medicine. The study suggests that nutritional management of diabetic peripheral neuropathy (DPN) with L-methylfolate, methylcobalamin, and pyridoxal 5'-phosphate, a prescription medical food dispensed by prescription and commercially known as Metanx®, improves total symptoms and health-related quality of life. The study, conducted by Vivian A. Fonseca, M.D. Tullis-Tulane Alumni Chair in Diabetes, Professor of Medicine and Chief, Section of Endocrinology at Tulane University School of Medicine, found significant improvement in both these areas after 24 weeks.

Type 2 Diabetes patients with symptomatic neuropathy often experience total symptoms including numbness, tingling and burning pain in the feet and/or hands. It is estimated that diabetic neuropathy affects 60-70 percent of the 26 million people in the U.S. with Type 2 diabetes. Nutritional management with Metanx® is believed to regulate the metabolic processes responsible for maintaining blood flow in the vessels that carry important nutrients and oxygen to the peripheral nerves.

Two hundred fourteen patients with Type 2 DPN were enrolled in the multicenter, double blind, placebo-controlled study and were randomized 1:1 to receive either Metanx® or identical placebo for 6 months. The Neuropathy Disability Score with Metanx® demonstrated greater improvement than placebo at 16 weeks, as was the Neuropathy Total Symptom Score-6 (NTSS-6), which showed greater improvement at 16 and 24 weeks in the Metanx® group than the placebo group. Significant improvement in quality of life was also observed with Metanx® in the Short Form-36 (SF-36) Mental Component subscale after 24 weeks compared to placebo.

There were no differences in total adverse events in the Metanx® group compared to the placebo group.  Adverse events were infrequent, with each event that was reported occurring in <2% of all subjects.

Dr. Fonseca commented on the study, "This study demonstrated that significant improvements with Metanx® were observed in measures of neuropathic symptoms and health-related quality of life, factors which may have a greater impact on patients' well being. This verifies that Metanx® could be a useful tool in managing patients with symptomatic diabetic neuropathy. Unlike current therapies on the market, Metanx has a unique mechanism of action that may be related to the pathophysiology of Diabetic Peripheral Neuropathy. I am delighted that Tulane University was able to work with Metanx® (Pamlab, L.L.C.®), a New Orleans area health care company, to conduct research that improves the lives of patients with diabetes."

The study can be found in The American Journal of Medicine and online here: 

About Diabetic Neuropathy
Diabetic neuropathy, or nerve damage caused by diabetes, is a chronic, progressive condition characterized by tingling, burning pain and numbness in the feet and/or hands. Numbness in the feet is the most common symptom associated with diabetic neuropathy and is the most frequent cause of ulceration and non-traumatic amputation. Additionally, burning pain occurs in 10 to 25 percent of DPN patients. Current therapies mask the painful symptoms of DPN but do not address the natural history of the disease, a challenge currently facing healthcare providers.

About Medical Foods and Metanx®
Medical foods are specially formulated to manage a specific disease or condition for which medical evaluation, based on recognized scientific principles, has established distinct nutritional requirements. All components of a medical food must have GRAS status (Generally Recognized as Safe) or be an approved food additive. 

Metanx® is a medical food dispensed by prescription and indicated for the distinct nutritional requirements of patients with endothelial dysfunction who present with loss of protective sensation and neuropathic pain associated with diabetic neuropathy. Metanx® offers a nutritional benefit by improving endothelial function and maintaining blood flow in the vessels that carry important nutrients and oxygen to the peripheral nerves.

About Pamlab, L.L.C.
Pamlab, L.L.C., founded in 1957, is a fully integrated pharmaceutical company specializing in medical foods indicated for the nutritional support of specific disease states including diabetic neuropathy, depression and mild cognitive impairment.

SOURCE Pamlab, L.L.C.