Use of combination folate/B6/B12 started almost two decades ago in the form of the prescription medical foods Foltx® and Metanx®. These products were promoted for use in DPN (Diabetic Peripheral Neuropathy) and numerous RCT studies showed both safety and efficacy in DPN patient management. In those early years, Neurologists and Podiatrists were often the biggest fan of this approach and they observed the direct benefits of this combination ingredient approach.
Foltx® and Metanx® are licensed and distributed by Alphasigma USA Inc.
In subsequent years, the combination ingredient approach was studied in a variety of applications:
• Functional/ Integrative Medicine – early therapy options prior to Rx alternatives
• Endothelial Dysfunction – as influenced by the regeneration of intracellular BH4, eNOS and thereby increased production of Nitric Oxide for effective vasodilation.
• Homocysteine Management – as influenced by overcoming genetic folate-related polymorphisms and enhancing the Hcy methylation cycle.
• Cognitive Management – as influenced by the active form of key ingredients (L-methylfolate) successfully crossing the blood brain barrier and addressing nutrient deficiencies in the brain.
• Mood Management – as influenced by the supply of tri-monoamine modulators across the blood brain barrier to increase the production of all three major neurotransmitters associated with mood modulation (Serotonin, Dopamine, Norepinephrine).
• Sleep Management – as influenced by the increased natural production of melatonin.
The Homocysteine Story (Hcy)
Elevated Homocysteine (Hcy) is consistently shown to be predictive of retinopathy and neuropathy among diabetics. Elevated Hcy is also shown to increase the risk of stroke and peripheral vascular disease (PVD) among diabetics.
As seen in the figure above, Folic Acid must complete a 5-step process in order to become the active form of folate (l-methylfolate) and play the role needed to effectively convert Hcy in the cellular methylation cycle. Both l-methylfolate and active B12 work as cofactors needed to convert Hcy into methionine. This methylation is used in the production of DNA and in protein synthesis.
NOTE: the presence of MTHFR enzyme (genetic limitation for many patients, more than half the general population has folate-related polymorphisms) is usually the rate limiting factor in the methylation cycle for Hcy. Up to 70% of US adults have enzyme limitations that affect their capacity to convert folic acid. By comparison, L-methlyfolate is fully and immediately absorbed at the cellular level.
L-methylfolate is also a cofactor in the creation of dopamine, norepinephrine and serotonin (tri-monoamines needed for proper mood management).
Drugs that routinely increase Hcy levels include: oral contraceptives, metformin, sulphasalazine, trimethoprim, Bile sequestrants (colestipol, cholestyramine), proton pump inhibitors, methotrexate, nitrous oxide, 1st and 2nd generation antiepileptics, lithium, levodopa and triamterene.
NeuronexST restores the metabolic imbalances responsible for vascular and neuronal repair. The Mechanism of Action is outlined above, and as follows:
Stabilizing BH4 (cofactor for eNOS) increases Nitric Oxide synthesis (<140%) resulting in vasodilation. L-arginine and eNOS is needed to complete Nitric Oxide synthesis.
Scavenging free radical formation from “uncoupled” eNOS.
Oxidative stress is also altered as the uncoupled eNOS provides for the formation of scavenging free radicals. Further switching the “uncoupled” eNOS to coupled eNOS further increases Nitric Oxide synthesis.
Pricing History
When Foltx and Metanx launched the combination therapy market for addressing DPN, the average monthly price to patients was approximately $15-30/month. Those products (and others like them) have risen over the years and are now routinely UP TO 4x that amount: $65-$180/month. Third party insurance coverage has long since vanished for most patients. These products are essentially “cash pay” only.
Imitation and substitution products have also cropped up (usually in the range of $45/mo). The new difficulty switched from high pricing to that of poor quality. Many of the these products use inferior ingredients (racemic versions rather than the active form, unstudied sub-ingredients that often fail to meet label claims, or simply the wrong combination in subtherapeutic dose amounts). All of these issues lead to inferior product results. Patients get discouraged and abandon using any products at all. This is not right and needs to be addressed.
At $35/bottle, Americeutical believes that NeuronexST provides an effective solution to this modern dilemma. We provide a product of excellent quality and the right dose. Better still, we cut out the “middleman” and can protect the price to the patient. NeuronexST delivers real value that you can trust.
Clinical Research
The following clinical studies have contributed to the development of NeuronexST:
THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.