the dietary management of chronic pain with medical foods
TRANSCRIPT
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The Dietary Management of Chronic PainPresented By: Marcus CharuvastraVice President of Marketing Targeted Medical Pharma, Inc.
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• 100 Million Americans Affected
• Almost 35% of the US Population
• $635 Billion a Year in Costs • By 2029, 20% of the US
Population will be 65 Years or Older
The Epidemic of Chronic Pain in America
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Persistent Pain Lasting Longer than 12 weeks
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Defining Chronic Pain
A Disease of the Nervous System
A Maladaptive Physiologic Response
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Low Back PainMigraine PainNeck PainFacial PainArthritic PainNeuropathic PainIdiopathic Pain
Most Common Types of Chronic Pain
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Most Common Drug Classes for Chronic Pain
Drug Class Example Adverse Side EffectsNSAIDs Ibuprofen, naproxen, meloxicam GI Bleed, Heart Attack, Stroke,
Renal Toxicity
Narcotics hydrocodone, oxycodone, fentanyl Addiction, Constipation, Drowsiness
Anticonvulsants Gabapentin, Lyrica, Topamax Clumsiness, Restlessness, Trouble Breathing, Depression
SSRI (Tricyclics) Nortripptyline, Amitriptyline Blurred Vision, Consitpation, Weight Gain, Increased HR
SNRI Effexor, Cymbalta Headache, Drowsiness, Loss of Appetite, Agitation
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• Altered Protein Metabolism• Increased Amino Acid Turnover 1
• Increased Neurotransmitter Turnover• Impaired GI Motility• Nutritional Deficiencies • Altered Central Nervous System
Function
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1. Shell, et al. American Journal of Therapeutics; 2012 108-114 ; Theramine ibuprofen trial 2010, Unpublished.
Physiologic Impact of Chronic Pain
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Chronic Pain Changes Brain Function and Chemistry• Chronic Back Pain Impacts the Cortex and Thalamus
• Gray Matter Atrophy Caused by CBP is 5-11% per Year Compared to .5% in the Normal Aging Process
• CBP Atrophy is Equivalent to 10-20 Years of Aging*
* Apkarian AV et al. J Neurosci. 2004;24:10410-10415
©2004 by Society for Neuroscience
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Chronic Back Pain Altering Amino Acid Metabolism
Arginine Serine Histidine Tryptophan0
5
10
15
20
25
30
35
CBP Change in Blood Concentration of Amino Acids2
Day 1
Day 28
Normalmg
% o
f Pro
tein
N=25
Patients with chronic pain syndromes have documented deficiencies of certain amino acids.1 Patients with chronic low back pain commonly present with lower levels of the amino acids required for producing pain modulating neurotransmitters compared to healthy subjects.2
1. Russell IJ, Michalek JE, Vipraio GA, Fletcher EM, Wall K. Serum amino acids in fibrositis/fibromyalgia syndrome. J Rheumatol Suppl 1989;19:158-1632. 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.
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Expanding and Augmenting Chronic Pain Treatments with Medical Foods
Medical Foods work through a different pathway from drugs, addressing the distinct physiologic and metabolic needs of chronic pain.
Manipulation vs. Creation
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Nutritional Requirements of Pain Syndromes
The altered metabolic processes associated with pain syndromes require additional amounts of 1-2 :•Arginine Nitric Oxide•Choline Acetylcholine•GABA GABA•Glutamine Glutamate, GABA, Glutathione
•Histidine Histamine•Tryptophan Serotonin•Serine d-Serine
1. Wurtman RJ. Nutrients affecting brain composition and behavior. Integr Psychiatry 1987;5:226-238.
2. Russell IJ, Michalek JE, Vipraio GA, Fletcher EM, Wall K. Serum amino acids in fibrositis/fibromyalgia syndrome. J Rheumatol Suppl 1989;19:158-163.
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Amino Acid Concentrations Affect the Ability of the Nervous System to Regulate
Pain
Choline Acetylcholine Potentiates NO and Serotonin
Inhibits NMDA receptor activity
Tryptophan 5-HTP SerotoninInhibits Substance
P and NMDA receptor activity
Decreases Pain Signals in CNS
Serine d-Serine Regulates NMDA receptor activity
Sensitizes opioid receptors
Arginine Nitric OxideInhibits afferent pain signals in
CNS
Vasodilator and opioid activator
Histidine HistamineStimulates
production of glucocorticoids
Modulates inflammation
GABA GABA Inhibits NMDA receptor activity
Dampens Pain Signals
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Medical Foods for the Dietary Management of Pain and Osteoarthritis
Product NAME Manufacturer IndicationTheramine® Targeted Medical Pharma Clinical Dietary Management of
Pain Disorders and Inflammatory Conditions
Limbrel® Primus Pharmaceuticals Clinical Dietary Management of the Metabolic Processes of Osteoarthritis
Trepdaone® Targeted Medical Pharma Clinical Ddietary management of the altered metabolic processes associated with pain and inflammation related to joint disorders. (JD)
Percura™ Targted Medical Pharma Blurred Vision, Consitpation, Weight Gain, Increased HR
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Theramine®for the dietary management of pain disorders and inflammatory conditions
“Naproxen and an Amino Acid Medical Food Theramine for the Treatment of Low Back Pain” American Journal of Therapeutics 2010.
Double-blind, multicenter, randomized 3 arm trial conducted at independent facilities in the USA with 129 subjects over 28 days.
44% reduction in back pain over 28 days.
65% reduction in back pain when combined
with low dose naproxen
17% reduction in CRP
“Reduction in Pain and Inflammation Associated with Chronic Low Back Pain with the use of the Medical Food Theramine” American Journal of Therapeutics 2014.
Double-blind, multicenter, randomized 3 arm trial conducted at independent facilities in the USA with 122 subjects over 28 days.
41% reduction in back pain over 28 days.
62% reduction in back pain when combined
with low dose ibuprofen
24% reduction in IL-6
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Limbrel®for the clinical dietary management of the metabolic processes of osteoarthritis
“Safety, efficacy and acceptability of flavocoxid (Limbrel®) compared with naproxen in subjects with osteoarthritis of the knee: A Pilot Study” Osteoarthritis and Cartilage Vol. 15.
Double-blind randomized trial conducted at facilities in Russia with 103 subjects for 30 days.
Significant reduction in the signs and symptoms
of knee OA.
Equivalent efficacy to 500mg naproxen in
controlling the signs and symptoms of OA
“ Efficacy and safety of flavocoxid, a novel therapeutic, compared with naproxen: a randomized multicenter controlled trial in subjects with osteoarthritis of the knee.” Advances in Therapy, 2010.
Double-blind, multicenter randomized trial conducted at independent facilities in the USA with 220 subjects for 12 weeks.
90% of subjects responded positively
Equivalent efficacy to 500mg naproxen, with far fewer UGI
and renal AEs
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Comprehensive Pain Management with Medical Foods
Reduce: Adjunct Therapy Poly-pharmacy, drug dose, and treatment duration
Replace: Standalone TherapyIneffective or dangerous drugs
Restore: Amino acid, nutrient and neurotransmitter levels, minimizing co-morbidities of chronic pain
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Medical Foods as an Adjunct to Low Dose Analgesics
-70
-60
-50
-40
-30
-20
-10
0
10 2.95
-44
-65
Reduction of Pain – Roland Morris Index
Percent Reduction of Roland-Morris Pain Index
Perc
ent (
%)
p<0.05
n=126
-70-60-50-40-30-20-10
010
0.730000000000001
-50.3
-63.1
Reduction of Pain - Roland-Morris Index
Roland-Morris Pain Scale
Perc
ent (
%)
p<0.01
Optimize Drug Dosages
Minimize Attenuation
Reduce Harmful Side Effects
Improve Clinical Outcomes
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Benefits to Providers and Pharmacists
•Generally Recognized as Safe Ingredients•Most Side Effects Comparable to Placebo•FDA Regulation and Oversight•Non-Addictive
Safety Profile•Supported by Multiple Double Blind Efficacy Studies•Individual Ingredient Efficacy •Fills the Treatment Gap that Drugs Cannot•Replacement/Adjuct Therapy for High Risk Narcotics & NSAIDsEfficacy Profile
•Encapsulated for Easy Use •Improved Tolerability•No Serious Side Effects Adherence and
Compliance
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Benefits to Patients and Caregivers
•Comparable to and More Effective than NSAIDs•Compliment to or Replacement for Narcotic Analgesics, SSRI, SNRI•Reduces Pain and InflammationAlternative
Therapy•Non-Addictive•Non-Sedative•Addresses Underlying Metabolic Demands of Pain DisordersNatural
Therapy
•Physician Oversight•No Serious Side Effects•Over 15 years of Professional Clinical UseSafe &
Effective
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Understanding the Market Potential
30 billion OTC tablets sold annually in the
USA
70 million annual NSAID prescriptions
in the USA
127 Million annual narcotic prescriptions
in the USA
100 million Americans with from
chronic pain
27 Million people with OA in USA
76 Million Baby Boomers in the USA
16,500 NSAID Related Deaths
Annually
16,651 Deaths Due to Rx Narcotics in
2010
Patients 65 and older
should not take NSAIDs
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The Future of Pain Management
• Pain• Inflammation• Co-morbidities• Poly-pharmacy• NSAIDs
Reduce
• Amino Acids and Neurotransmitters depleted by disease
• Dangerous and Addictive Drugs
• Ineffective Therapies
Replace
• Nervous System Function
• Pain Control• Daily Function• Homeostasis
Restore
