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Percura, Improve Pain and Numbness Associated with Peripheral Neuropathy

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Percura capsules by oral administration. A specially formulated Medical Food product, consisting of a proprietary blend of amino acids in specific proportions, for the dietary management of the metabolic processes associated with pain, inflammation and loss of sensation due to peripheral neuropathy. Must be administered under physician supervision.

Percura is a proprietary formulation of amino acids and other dietary factors to support induction, maintenance, and enhancement of the specific neurotransmitter activity involved in the physiology of neuropathic pain. The formulation consists of nonessential and essential amino acids L-Arginine HCL, L-Histidine HCL, L-Glutamine, L-Serine, L-Lysine, L-Ornithine, Acetyl L-Carnitine, L-Tyrosine, the nonstandard amino acid Gamma Aminobutyric Acid, Choline Bitartrate, Glucose, Inositol, Griffonia Extract griffonia simplicifolia (95% 5-HTP) , and Creatine. These ingredients fall into the classification of Generally Recognized as Safe (GRAS) as defined by the Food and Drug Administration (FDA) (Sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act). A GRAS substance is distinguished from a food additive on the basis of the common knowledge about the safety of the substance for its intended use. The standard for an ingredient to achieve GRAS status requires not only technical demonstration of non-toxicity and safety, but also general recognition of safety through widespread usage and agreement of that safety by experts in the field. Many ingredients have been determined by the FDA to be GRAS, and are listed as such by regulation, in Volume 21 Code of Federal Regulations (CFR) Sections 182, 184, and 186.

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Percura, Improve Pain and Numbness Associated with Peripheral Neuropathy

  1. 1. 2 Responsible Pain Management •Amino Acid Based Formula •No Severe Side Effects •Reduce Pain, Inflammation & Numbness •Alternative and Complimentary Therapy to Commonly Prescribed Medications
  2. 2. 3 Indication & Dosing Percura™ for the dietary management of pain, inflammation and loss of sensation due to peripheral neuropathy. DOSAGE AND ADMINISTRATION Recommended Dosing: 1 or 2 capsules taken 1 to 2 times daily or as directed by physician.
  3. 3. 4 Targeted Amino Technology The efficacy of Percura is driven by a unique ingredient technology that stimulates the production of specific progenitor cells and neurotransmitters with specific roles in pain management and cell to cell signaling.
  4. 4. 1. Russell IJ, Michalek JE, Vipraio GA, Fletcher EM, Wall K. Serum amino acids in fibrositis/fibromyalgia syndrome. J Rheumatol Suppl 1989;19:158-163 2. Shell, et al., “A Double-Blind Controlled Trial of a Single Dose Ibuprofen and an Amino Acid Medical Food Theramine for the Treatment of Low Back Pain; Publication pending, 2010. There are well documented amino acid deficiencies in patients with chronic pain syndromes. These deficiencies can alter the metabolic processes associated with neurotransmitter synthesis. For example, in one double blind study, subjects with chronic back pain who improved low levels of the amino acids required for production of pain modulating neurotransmitters using a medical food reported a significant improvement in pain. 5 Amino Acid Levels and Chronic Pain 0 5 10 15 20 25 30 35 Arginine Serine Histidine Tryptophan Ug/ml Change in Blood Concentration of Amino Acids2 Day 1 Day 28 Normal N=25
  5. 5. 6 Clinical Response Data In a clinical outcomes study of Percura, patients with peripheral neuropathy experienced a reduction in pain and numbness over a 56 day period as measured by a 10 point Physician Global Assessment Visual Analog Scale. 0 1 2 3 4 5 6 7 8 9 Baseline 28 56 VAS DAYS Physician Global Assessment Visual Analog Scale Pain Numbness
  6. 6. 7 Clinical Response Data -29.5 -23.1 -35 -30 -25 -20 -15 -10 -5 0 Pain Numbness Physician Global Assessment Visual Analog Scale Pain Numbness In a clinical outcomes study of Percura, patients with peripheral neuropathy experienced a reduction in pain and numbness over a 21 day period as measured by a 100 point Physician Global Assessment Visual Analog Scale.
  7. 7. 8 Nerve Impulse and Activation Inflammation Pain & Numbness GABA, Serotonin, Dopamine, Acetylcholine, Nitric Oxide and D-serine Histamine, Nitric Oxide, Acetylcholine Inositol Creatine Improve Clinical Outcomes
  8. 8. • Patients who are contraindicated for NSAIDs (High BP, Over 65, CVD, Taking Aspirin) • Patients who experience severe side effects from Pregabalin or Gabapentin • Percura can be used as an adjunct therapy to a low dose of a drug 9 Alternative to NSAIDs & Anti-Epileptics
  9. 9. 10 • Percura can be used as an adjunct therapy to a low dose opioid pain medication • Percura can be used as a replacement therapy for other ineffective or dangerous pain medications Alternative to Narcotic Pain Medications
  10. 10. Percura is a source of amino acids, biogenic amines, and botanicals that promote the production of neurotransmitters responsible for reducing signals along the ascending and descending pain pathways and inflammatory pathways. Pain and inflammatory conditions increase the turnover rate of arginine, choline, GABA, glutamine, histidine, 5-hydroxytryptophan, and serine. Simple dietary modifications are not sufficient to satisfy cellular demand and restore homeostasis to the ascending and descending pain pathways and inflammatory processes. 11 Neurotransmitter Pathways
  11. 11. Progenitor cells are developmentally committed to a cell line but are undifferentiated or immature in comparison to those cells that have differentiated and matured into specialized cells. Progenitor cells are multipotent or unipotent. Activation of neuronal progenitor cells through growth factors such as creatine can lead to increased cell division important for the repair process in peripheral sensory nerves.* Progenitor Cell Pathways 12 *Murakami, et al. Transplanted neuronal progenitor cells in a peripheral nerve gap promote nerve repair. Brain Research, 2003.
  12. 12. PRECAUTIONS AND CONTRAINDICATIONS Percura is contraindicated in an extremely small number of patients with hypersensitivity to any of the nutritional components of Percura. ADVERSE REACTIONS Oral supplementation with L-arginine at high doses up to 15 grams daily is generally well tolerated. The most common adverse reactions of higher doses - from 15 to 30 grams daily - are nausea, abdominal cramps, and diarrhea. Percura contains less than 1 gram per dose of amino acids however, some patients may experience these sympotoms at lower doses. The total combined amount of amino acids in each Percura capsule does not exceed 500mg. Safety Information 13
  13. 13. DRUG INTERACTIONS Percura does not directly influence the pharmacokinetics of prescription drugs. OVERDOSE There is a negligible risk of overdose with Percura as the total amount of amino acids in a one month supply (120 capsules) is less than 60 grams. Overdose symptoms may include diarrhea, weakness, and nausea. Safety Information Cont. 14
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  15. 15. For More Information visit www.tmedpharma.com 16

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