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.
2. 2
Responsible Pain Management
•Amino Acid Based Formula
•No Severe Side Effects
•Reduce Pain, Inflammation & Numbness
•Alternative and Complimentary Therapy
to Commonly Prescribed Medications
3. 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.
4. 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.
5. 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
6. 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
7. 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.
9. • 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
10. 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
11. 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
12. 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.
13. 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
14. 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
15. 15
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Select References
Example Continued:
Decrease in Choline means decreased parasympathetic autonomic nervous system activity due to pain disorder. Decrease in choline causes increased creatine phosphokinase and alanine transaminase, and must be addressed.
With Theramine:
Administration of choline increases production of acetylcholine which reduces transmission of pain signals and inhibits proinflammatory cytokines and substance P release without noxious side effects related to harmful drugs