Reviews in Neurological Diseases Publishes a Study That Demonstrates How Metanx® Improves Numbness in Diabetic Neuropathy Patients

Medical food product provides nutritional management for patients with symptomatic diabetic neuropathy in contrast to current pain masking therapies

NEW ORLEANS--(BUSINESS WIRE)--PamLab L.L.C., developer and marketer of Metanx^®, announced today that the results of a study to determine if nutritional management with Metanx^® improves numbness in the feet of patients with Diabetic Neuropathy (DN) was published in the fourth quarter 2010 issue of Reviews in Neurological Diseases. The study demonstrated that Metanx^®, a medical food available by prescription, promotes restoration of lost cutaneous sensation in DN patients.

“Unlike the current standards of care, which only mask the painful symptoms, Metanx® manages the nutritional needs of the patient with Diabetic Neuropathy, maintaining blood flow and creating an environment for increased nerve fiber density; thus, enhancing the patient’s quality of life.”

Diabetic Neuropathy, nerve damage caused by diabetes, is a chronic condition characterized by tingling, burning pain, and numbness in the feet and/or hands. It is estimated that 60-70 percent of the 23.6 million people with diabetes in the U.S. have some form neuropathy. Numbness in the feet is the most common symptom associated with diabetic neuropathy and is the most frequent cause of ulceration and amputation. Additionally, burning pain occurs in 10 to 25 percent of DN patients. Current therapies mask the painful symptoms of DN but do not address the numbness or underlying progression of the condition, a challenge currently facing health care providers.

Mackie J. Walker Jr., DPM, of the Podiatry Division of the Carolina Musculoskeletal Institute in Aiken South Carolina acted as lead study investigator. “There is considerable need for a therapy like Metanx^®, as it has demonstrated to improve sensory loss with a favorable safety profile,” stated Dr. Walker.

“Diabetic Neuropathy is an under-recognized and significantly underserved result of type 2 diabetes,” said Harold O. Koch, Jr., Senior Vice President of Business & Scientific Affairs, and Chief Scientific Officer of Pamlab. “Unlike the current standards of care, which only mask the painful symptoms, Metanx^® manages the nutritional needs of the patient with Diabetic Neuropathy, maintaining blood flow and creating an environment for increased nerve fiber density; thus, enhancing the patient’s quality of life.”

The efficacy of nutritional management with Metanx^® in restoring sensitivity in patients with type 2 diabetes was measured in three follow-up periods: baseline to 6 months, baseline to 1 year, and 6 months to 1 year. After 6 months and 1 year of Metanx^® compared to baseline, a statistically significant improvement was observed in both tactile and discriminatory testing at the right and left great toe and medial heel of patients. The results of this study were originally presented in 2008 at the New Cardiovascular Horizons Meeting in New Orleans.

About Medical Foods and Metanx^®

As regulated by the FDA, 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) as designated by the FDA or independent review.

Metanx^® is a medical food available 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^® contains the active forms of folate and Vitamins B₁₂ and B₆ (L-methylfolate, methylcobalamin, and pyridoxal 5’-phosphate, respectively). 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 specific disease states including diabetic neuropathy, depression and early memory loss.