AD Trifold

A new Rx Homocysteine - lowering B vitamin/omega 3 option to improve

or arrest cognitive decline in MCI, mild to moderate AD, or Vascular Dementia with raised Hcy levels.

(2.5mg F-THF, 1mg PteGlu CR, 7mg Me-THF-Mg, 13.6mg FeGC, 6.4mg PS-DHA, 800mcg PS-EPA)Plus CitraFolic, AminoFerr, MagnaFolTM, and Sharp-PS GOLDDIETARY MANAGEMENT / PRESCRIPTION (Rx) FOLATEMULTIPHASIC SOFTGELPRODUCT CODE 64661-711 / PART-ID 711-30CERTIFIED GLUTEN-FREE - LOW IRON

DESCRIPTION: EnLyte is an orally-administered prescription folate-containing product for the clinical dietary management of depression related to suboptimal folate levels associated with metabolic imbalances in transformylation and/or methylation biochemistry.1-8,20 Folate appears to enhance synthesis and/or regeneration of tetrahydrobiopterin (BH4), which is an essential cofactor in the biosynthesis of monoamine neurotransmitters serotonin, dopamine and norepinephrine.15,16,17 Additionally, folate may normalize elevated homocysteine levels and reduce the risk of neural tube defects. Elevated homocysteine has been observed among women with neural tube defect (NTD)-affected pregnancies.36 The protective effect of DeltaFolateTM in EnLyte comes in supplying an array of folate-derivatives in combination with folate coenzymes, cofactors and co-metabolites that decrease the risk of bioavailability-interference such as might occur with inborn or environmental folate-malabsorption. This allows the folate substrate, THF, to be utilized in transformylation and/or methylation biochemistry.1-8,14 EnLyte can be taken by women of childbearing age, pregnant women, and lactating and nonlactating mothers.INGREDIENTSa: Each oval, annatto-colored MULTIPHASIC soft gelatin capsule contains the following 8.73 mg of active vitamin B9 moiety from 16 mg DeltaFolateb provided as:Formyltetrahydrofolic acid (equiv. to 2.5 mg moiety) .......................................................................................................................................................................3 mgControlled-release citrated-pteroylmonoglutamic acid, USP as CitraFolicc (equiv. to 1 mg moiety) ............................................................................................6 mgMethylfolate magnesium as MagnaFold (equiv. to 5.23 mg moiety)............................................................................................................................................7 mgALSO CONTAINSa: The following distinct dietary ingredients as necessary cofactors, coenzymes and co-metabolitesfor advanced folate supplementation:FeGC as ferrous glycine cysteinate (1.5mg elemental iron) from pure amino acid chelate as AminoFerr ...................................................................................................13.6 mgPS-DHA as phosphatidylserine-docosahexaenoic acid from PS-DHA-Ca as Sharp-PS Gold..................................................................................................6.4 mgPS-EPA as phosphatidylserine-eicosapentaenoate acid from PS-EPA-Ca as Sharp-PS Gold .............................................................................................. 800 mcgPhosphatidylserine from Sharp-PS GOLDf................................................................................................................................................................................12 mgAscorbates [as 24 mg magnesium ascorbate and 1 mg zinc ascorbate] .................................................................................................................................... 25 mgThiamine pyrophosphate ............................................................................................................................................................................................................ 25 mcgFlavin adenine dinucleotide (FAD) .............................................................................................................................................................................................. 25 mcgNicotinamide adenine dinucleotide hydride (NADH) ................................................................................................................................................................... 25 mcgPyridoxal 5 phosphate (P5P) .................................................................................................................................................................................................... 25 mcgCobalamin .................................................................................................................................................................................................................................. 50 mcgBetaine (trimethylglycine) ......................................................................................................................................................................................................... 500 mcgL-threonate magnesium ..................................................................................................................................................................................................................1 mga Daily Values not established for patients with unique nutritional needs who are in need of supplementation as directed by a licensed medical practitioner.b DeltaFolateTM is a proprietary folate blend consisting of folinic acid, folic acid and methylfolic acid providing 8.73 mg of active vitamin B9 moiety.c CitraFolic is a controlled-release form of folic acid that is pH-specific using citrates as buffers to achieve optimal absorption for targeted-GI at the proximal jejunum AND in order to meet USP requirements for folic acid dissolution and disintegration; it is patent pending. CitraFolic uses only DMF-approved manufacturers of folic acid.d MagnaFol is the magnesium salt of methylfolic acid - also known as LEVOMEFOLATE MAGNESIUM, and has the Unique Ingredient Identifier (UNII) code 1VZZ62R081; the active moiety being LEVOMEFOLIC ACID, and has the UNII 8S95DH25XC. MagnaFolTM, or l-methylfolate magnesium, has the CAS #1429498-11-2; and has U.S. patent applications pending.e AminoFerr as ferrous glycine cysteinate, also known as FERROUS CYSTEINE GLYCINATE, and has the UNII code 8B4OP7RK5N. AminoFerr is a proprietary ingredient containing pure chelates without interfering ions -resulting in high solubility and absorption;it is the only pure amino acid iron chelate supplement on the market, and is protected under US Patent No. 7,341,708.f Sharp-PS GOLD is an omega-3 derived complex comprising phospholated docosahexaenoic (DHA) and eicosapentaenoic acid (EPA), and is protected under U.S. Patent Nos. 7,935,365 and 5,965,413. It has the following two metabolic substrates*: (1) PS-DHA as the active ingredient phosphatidylserine-docosahexaenoate calcium salt (PS-DHA-Ca) - also known as 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, and has UNII code 6WJM73T46K; the active moiety being phosphatidylserine-docosahexaenoic acid (PS-DHA) - also known as 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE, and has UNII code DVY07ILF1W. AND, (2) PS-EPA as the active ingredient phosphatidylserine-eiconosapentanoate calcium salt (PS-EPA-Ca) - also known as 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, and has UNII code 9ABD9DRK7B; the active moiety being phosphatidylserine-eiconosapentanoic acid (PS-EPA) - also known as 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE, and has UNII code C3019D8IIA.* Both di-ester salts of the omega-3 derivatives have the calcium element as CALCIUM CATION UNII code 2M83C4R6ZB.EXCIPIENTS: Annatto (color), gelatin (bovine), glycerin, lecithin (sunflower), natural creamy orange (flavor), olive oil, piperineg (bioavailability enhancer), purified water, r-5-formylTHF, ubidecarenone (trace amounts), yellow beeswax,....[and other ancillary ingredientsh as needed to ensure product stability] ...g Bioavailability enhancer piperine as BioPerine is a registered trademark of Sabinsa Corporation, Piscataway, NJ. Protected and manufactured under US Patent Nos. 5,536,506, 5,744,161, 5,972,382; and 6,054,585.h Since additives, preservatives, bioavailability enhancers, colors and/or flavors of natural origin, etc. are preferred over synthetics, it may be the case that product color, appearance and/or taste may vary slightly over time; and it may be necessary to substitute excipients during the manufacturing process as needed to preserve product appearance and continuity in order to avoid confusion in the marketplace and ensure the highest therapeutic target, safety and quality.EnLyte DOES NOT CONTAIN artificial dyes, artificial flavors/ sweeteners, and gluten. EnLyte is third-partyv certified gluten-free. EnLyte contains less than 5000 ppm alcohol.ALLERGY STATEMENT: EnLyte contains soy and fish (blue whiting and herring) derived Sharp-PS GOLD. This ingredient, however, does not contain detectable levels of fish and soy protein due to an extensive purification process. Neverless, EnLyte has been manufactured in a facility that also manufactures products containing tree nuts, peanuts, fish, egg, wheat, milk, soy and shellfish. Patients with allergic tendencies to any of these substances should use discretion and consult their healthcare practitioner for advice. EnLyte also contains bovine gelatin.WARNINGS:This product contains iron. EnLyte should not be used by individuals at risk for iron overload (including transfusional overload) or other conditions for which iron is contraindicated. Warning: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately.[PSYCHIATRIC] Caution is recommended in patients with a history of bipolar illness as mood elevation is possible following coadministration of folate with antidepressant therapy in situations of severe folate deficiency. Caution is also recommended with schizophrenic patients as it is imperative that positive symptoms in schizophrenia be treated with therapies (e.g., antipsychotic medications) that are accepted by licensed psychiatric professionals as being safe and effective. EnLyte should not be administered to patients with positive symptoms.[NEUROCOGNITIVE] Caution is recommended in patients taking anticonvulsant medications as folate may interfere with anticonvulsant medication, and may lower seizure threshold.9 Furthermore, it has been reported that anticonvulsant medications interfere with folate metabolism, but the exact action is unclear; therefore caution is recommended with patients in this therapeutic group.10 Caution is likewise recommended in Parkinsons disease patients as EnLyte contains vitamin B6 which may or may not interfere with levodopa (even when administered with carbidopa).[ONCOLOGY] Folinic acid may enhance the toxicity of fluorouracil. Deaths from severe enterocolitis, diarrhea, and dehydration have been reported in elderly patients receiving weekly formyl-THF and fluorouracil. Concomitant granulocytopenia and fever were present in some but not all of the patients. Individuals undergoing treatment for cancer or certain inflammatory conditions or who have a history of precancerous neoplasms should consult their medical practitioner to determine if EnLyte is appropriate for them.PRECAUTIONS: Folate alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folate in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission may occur while neurological manifestations progress.Daily ingestion of more than 3 grams per day of omega-3 fatty acids (ALA, EPA, and DHA) may have potential antithrombotic activities, or effects, and may increase bleeding times. Administration of omega-3 fatty acids, including DHA, should be avoided in patients with inherited or acquired bleeding diathesis, including those taking anticoagulants. Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.INTERACTIONS: Talk to your healthcare practitioner and/or pharmacist before taking or using any prescription or overthecounter medicines or herbal/health supplements alongside EnLyte. Folinic acid may enhance the toxicity of fluorouracil (see WARNINGS).CONTRAINDICATIONS: EnLyte is contraindicated in patients with a known hypersensitivity to any of the components contained in this product. EnLyte is contraindicated for individuals with conditions for which any of the EnLyte ingredients are contraindicated. EnLyte is also contraindicated for individuals who would be negatively affected by increased monoamine neurotransmitter synthesis.ADVERSE REACTIONS: Allergic reactions have been reported following the use of oral and parenteral folate. Paresthesia, somnolence, nausea, and headaches have been reported with pyridoxine. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body has been associated with cobalamin. These are not all the possible side effects associated with EnLyte. It is important to always contact your healthcare practitioner if you experience any side effects on EnLyte. You may report side effects by calling (866) 280-5961.INDICATIONS AND USAGE: EnLyte is indicated for the distinct nutritional requirements of individuals who have suboptimal folates levels in the cerebrospinal fluid, plasma and/or red blood cells, and require a maintenance level. Folate is effective in the treatment of hyperhomocysteinemia and/or megaloblastic anemias12 (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin13, pregnancy, infancy, childhood or other related folate-malabsorption complications of an inborn or environmental origin.14,43 EnLyte is not a drug, but may be used as monotherapy (rescue therapy) or adjunctive therapy as determined by your licensed medical practitioner. The adjunctive use of EnLyte enables medical practitioners to combine therapeutic modalities (dietary management and drug therapy).18,19 In patients with suboptimal folate levels and as determined by your licensed medical practitioner, EnLyte may be administered as rescue or adjunctive folate-therapy to provide a protective effect in reducing the risk of secondary/endpoints and/or disease-states of a hyperhomocysteinemia and/or vascular nature such as may be found with depression; or EnLyte may be administered as rescue or adjunctive folate-therapy to provide a protective effect in reducing the risk of secondary/endpoints and/or disease-states of a hyperhomocysteinemia and/or methylation metabolic imbalance as may be found with depressed patients.PREGNANCY AND NURSING MOTHERS: EnLyte is a prescription (Rx)-folate containing dietary supplement (prenatal/postnatal) formulated for use by lactating and nonlactating women who are at risk of postpartum depression, depression before or during a pregnancy, and/or women of childbearing age who may become pregnant and/or are in need of increased folate levels in the central nervous system (CNS). EnLyte may also be an appropriate folate supplement for those at high risk of NTDs because of the amount and diversity of folates. EnLyte is Pregnancy Category A; however, EnLyte is NOT a standard complete prenatal/postnatal supplement for the following reasons:EnLyte contains over 1,000% of DV of folate for pregnant and lactating women, which may or may not be important depending upon your genetic disposition and previous pregnancies; please consult with your licensed medical practitioner on advanced folate supplementation during pregnancy for women at risk of NTDs and/or suboptimal folate/depression/postpartum. EnLyte contains piperine a dietary ingredient derived from pepper.9,10 EnLyte contains a minimal amount of iron providing only 8% of DV of iron for pregnant and lactating women, and EnLyte does not contain other vitamins and minerals that might be more suitable to your specific metabolic needs or part of a standard prenatal/postnatal multivitamin/multimineral/dietary supplement.7-9,10GERIATRICS: EnLyte is formulated for the clinical dietary management of depression specifically related to suboptimal folate levels. EnLyte contains 1.5 mg of elemental iron, which is approximately 19% of the recommended dietary allowance for individuals over the age of 51.48 DOSAGE AND ADMINISTRATION: The recommended dose is one softgel daily or as directed under medical supervision to achieve a satisfactory folate-maintenance level. Some individuals may require larger doses as determined by a licensed medical practitioner.EnLyte is best absorbed when taken on an empty stomach. During times of medication transition, the amount of EnLyte may be increased as per direction of your licensed medical practitioner in order to achieve a rescue effect. It is important to obtain vitamin D supplementation preferably through the natural process of sun exposure though not to the point of skin damage, as vitamin D acts as a neuro-immunomodulator and therefore enhances the therapeutic goals of EnLyte.HOW SUPPLIED: EnLyte is supplied as oval, annatto-colored soft gelatin capsules with ENL on one side, in bottles of 30 softgels with NDC 64661-711-30. EnLyte is also supplied to licensed healthcare practitioners as samples, 64661-711-05. This product is a prescription-folate with or without other dietary ingredients that due to increased folate levels (AUG 2 1973 FR 20750), requires an Rx on the label because of increased risk associated with masking of B12 deficiency (pernicious anemia). Based on our assessment of the risk of obscuring pernicious anemia, this product requires licensed medical supervision, an Rx status, and a National Drug Code (NDC) or similarly-formatted product code, as required by pedigree reporting requirements and supply-chain control as well as in some cases, for insurance-reimbursement applications.EnLyte may under certain circumstances, be dispensed through a certified mail-order program so long as there is record of prescription AND confirmation that the patient is under licensed medical supervision. This product is not an Orange Book (OB) rated product, therefore all prescriptions using thisproduct shall be pursuant to State statutes as applicable. STORAGE: Store at 20-25 C (68-77 F). Excursions permitted to 15-30 C (59-86 F). [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container. Call your doctor about side effects. You may report side effects by calling (866) 280-5961.KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN.MANUFACTURED FOR: JAYMAC Pharmaceuticals, LLC (Sunset, Louisiana, USA). EnLyteRx.com. MADE IN CANADAPATENTS: US Patent Nos. 7,935,365; 5,965,413; 7,341,708; 6,054,585; 5,972,382; 5,744,161; 5,536,506; and other patent applications pending.TRADEMARKS: EnLyte is a registered trademark of JAYMAC Pharmaceuticals, LLC (Sunset, Louisiana, USA), and was co-developed by Daniels-Trezza, LLC. CitraFolic and MagnaFolTM are registered trademarks of Viva Pharmaceuticals, Inc. (Richmond, B.C., Canada), and was co-developed by Daniels-Trezza, LLC. DeltaFolateTM is a use-trademark of Daniels-Trezza, LLC (Ft. Myers, FL). AminoFerr is a registered trademark of Viva Pharmaceuticals (Richmond, BC, Canada). Sharp-PS GOLD is a registered trademark of Enzymotec Ltd. (Israel).

Recent Clinical Trial Results

Your patients have two easy options for obtaining EnLyte.

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Prescribe EnLyteComplete care to treat mild, moderate, and severe depression2

Essential cornerstone in the treatment of all patients with depression

Stand-alone or adjunctive therapy

Contains optimal ingredients

Most reduced form of folate (16 mg DeltaFolate)

Most reduced brain-ready forms of vitamin B

Zinc

AdvAnced generAtion folAte therApy 2013 JAYMAC Pharmaceuticals, LLC. All rights reserved.

(actual size)

No artificialsweeteners

Dye-free Gluten-free Calcium-free Casein-free

Guarantee for cash payment: No shipping charge when shipped via US Postal Service. (Please add 3 to 4 business days for processing prescription orders and 2 to 9 business days for shipping, depending on location.) For questions about ordering through Linden Care, call 877-9Linden (877-954-6336).

[EnLyte] addresses the root cause of depression, not just

the symptoms of depression its a real paradigm shift.

Andrew Farah, MD, Chief of Psychiatry, High Point Section of UNC Health Care, Central NC June 19, 2013, oral communication

Scan the QR code above to watch the full video of Dr. Farahs interview.

Phone Fax ePrescription to

Patients may also fill their prescription for EnLyte through Speialty Medical Drug Store Mail Order/Cash Pay* program with no additional service or shipment fees.

EnLyte is available by prescription and can easily be filled at local pharmacies with insurance, Medicaid, and Medicare for a reasonable co-pay.

For any questions regarding EnLyte, patients can call

985-788-7755

Your patients have two easy options for obtaining EnLyte.

30-day supply of EnLyte

1

2

References: 1. Rosenberg I. Physician letters. The Physician Exchange website. (Registration required). http://www.thephysicianexchange.com/kol_letters. aspx. Accessed July 16, 2013. 2. EnLyte [package insert]. Sunset, LA: JAYMAC Pharmaceuticals, LLC; 2012. 3. Gu P, DeFina LF, Leonard D, et al. Relationship between serum homocysteine levels and depressive symptoms: the Cooper Center Longitudinal Study. J Clin Psychiatry. 2012;73(5):691695. 4. Stahl SM. Novel therapeutics for depression: L-methylfolate as a trimonoamine modulator and antidepressant-augmenting agent. CNS Spectr. 2007;12(10):739744. 5. Tanaka T, Scheet P, Giusti B, et al. Genome-wide association study of vitamin B6, vitamin B12, folate, and homocysteine blood concentrations. Am J Hum Genet. 2009;84(4):477482. 6. Jolliffe T. Folate levels influence depression symptoms. Spark People website.http://www.sparkpeople.com/blog/blog.asp?post=folate_levels_influence_depression_symptoms. Accessed August 11, 2013. 7. Ortega RM, Lopez-Sobaler AM, Gonzalez-Gross MM, et al. Influence of smoking on folate intake and blood folate concentrations in a group of elderly Spanish men. J Am Coll Nutr. 1994;13(1):6872. 8. Mountifield JA. Effects of oral contraceptive usage on B12 and folate levels. Can Fam Physician. 1985;31:15231526. 9. Fava M, Mischoulon D. Folate in depression: efficacy, safety, differences in formulations, and clinical issues. J Clin Psychiatry. 2009;70(suppl 5):1217. 10. Gelenberg AJ, Freeman MP, Markowitz JC, et al. Practice Guideline for Treatment of Patients With Major Depressive Disorder. 3rd edition. Arlington, VA: American Psychiatric Publishing; 2010. 11. Consumer Reports Best Buy Drugs. Using antidepressants to treat depression: comparing effectiveness, safety, and price (2013). Consumer Reports website. http://www.consumerreports.org/health/resources/pdf/best-buy-drugs/Antidepressants_update.pdf. Accessed October 24, 2013. 12. Rosenberg M. Physician letters. The Physician eXchange website. (Registration required) http://www.thephysicianexchange.com/kol_letters2.aspx. Accessed July 3, 2013. 13. Trivedi MH, Rush AJ, Wisniewski SR, et al. Evaluation of outcomes with citalopram for depression using measurement-based care in STAR*D: implications for clinical practice. Am J Psychiatry. 2006;163:2840. 14. Passeri M, Cucinotta D, Abate G, et al. Oral 5- methyltetrahydrofolic acid in senile organic mental disorders with depression: results of a double-blind multicenter study. Aging (Milano). 1993;5(1):6371. 15. Wright CB, Lee HS, Paik MC, Stabler SP, Allen RH, Sacco RL. Total homocysteine and cognition in a tri-ethnic cohort: the Northern Manhattan Study. Neurology. 2004;63(2):254260. 16. Taylor MJ, Freemantle N, Geddes JR, Bhagwagar Z. Early onset of selective serotonin reuptake inhibitor antidepressant action: systematic review and meta-analysis. Arch Gen Psychiatry. 2006;63(11):12171223. 17. WebMD. The truth about antidepressants. WebMD website. http://www.webmd.com/depression/antidepressants -9/slideshow-antidepressants. Accessed July 10, 2013.

May not be payable on all programs.

Phone 1-888-795-5826 with your Rx informationFax 1-513-576-0092 orePrescription to specialtymedicaldrugstore

Enhanced Rx Folate, B Vitamin Co-Enzyme, Mineral Cofactor, Omega 3Therapy

The process of memory

decline and brain shrinkage associated with

AD is thought to occur over

a 30 to 40 year period. Screen

and Treat at age 50.

Smith Found Levels of Hcy, above 9.5 mmol/l, correlated with accelerated brain shrinkage and cognitive decline. Those given folate, B12 and B6 had a significant reduction in the rate of brain shrinkage. The rate of brain atrophy was 53% lower over a two year period in the active treatment group.Smith , A.O. et al ., Homocysteine-lowering by B vitamins slows the rate of accelerated brain atrophy in mild cognitive impairment: a randomized controlled trial, Public Library of Science ONE, 5(9) (2010)

Douaud Found Patients with raised Hcy given B vitamins, compared to placebo had an eight-fold reduction in shrinkage of the medial temporal lobe, which is the specific area of the brain that shrinks in AD.Douaud, G. , et al. (2013) Preventing Alzheimers diseaserelated gray matter atrophy by B vitamin treatment. Proc Natl Acad Sci US A. 2013 Jun 4;110(23):9523-8

Kwok Gave B vitamins to those with mild to moderate AD or vascular dementia and reported no further decline in cognitive function, but only in those with raised homocysteine.Kwok, T., et al. (2011) A randomized placebo controlled trial of homocysteine lowering to reduce cognitive decline in older demented people. Clinical Nutrition, 30: 297-302.

Jernern Noted From the Smith study that B vitamins plus high omega 3 levels showed a 70% decrease in the rate of brain shrinkage, bringing their level of brain shrinkage down to that seen in healthy elderly who do not develop dementia.Jerneren F, Elshorbagy AK, Oulhaj A, Smith SM, Refsum H, Smith AD (2015). Brain atrophy in cognitively impaired elderly: the importance of long-chain w-3 fatty acids and B vitamin status in a randomized controlled trial. Am J Clin Nutr. 2015 Apr 15. pii: ajcn103283. [Epub ahead of print]

How does EnLyte work? Exactly who can benefit from EnLyte?

High Homocysteine levels, low folate and B12 levels in blood correlate with increasing risk for MCI and vascular dementia, and Alzheimers Disease

EnLyte actual ingredients:6(S)-5-MeTHF-magnesium 7 mg6(S)-5-FormylTHF sodium 3 2.5 mgCitrated folic acid CR-USP 1 mg5-deoxyadenosylcobalamin 50 mcgIron Chelate 13.6 mgPyridoxal 5 phosphate 25 mcgThiamine pyrophosphate 25 mcgFlavin adenine dinucleotide 25 mcgNADH 25 mcgPS-DHA 6.4 mgPS-EPA 800 mcgPhosphatidylserine 12 mgMagnesium Ascorbate 24 mgZinc Ascorbate 1 mgMagnesium L-Theoronate 1 mgTrimethylglycine (betaine) 500 mcgCoenzyme Q10 500 mcgBioperine 500 mcg

INDICATIONS AND USAGE: Enlyte is indicated for the distinct nutritional requirements of individuals who have suboptimal folates levels in the cerebrospinal fluid, plasma and/or red blood cells, and require a maintenance level. Folate is effective in the treatment of hyperhomocysteinemia and/or megaloblastic anemias.WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

Important Safety InformationDaily ingestion of more than 3 grams per day of omega-3 fatty acids (ALA, EPA, and DHA) from fish oils may have potential antithrombotic activities, or effects, and may increase bleeding times. Administration of omega-3 fatty acids, including DHA, should be avoided in individuals with inherited or acquired bleeding diathesis, including those taking anticoagulants. Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.Please see full indication and prescribing information in back pocket.

Reduces homocysteine, maximizes production of neurotransmitters,glutathione, and methylates DNA by completely addressing the needs of the remethylation and transsulfuration cycles2

Enlyte is indicated for Hyperhomocysteinemia

Enlyte proven clinically to significantly reduce Hcy

Enlyte reduced homocysteine levels 33% compared to placebo in a 330 MTHFR C677T patient double-blind placebo controlled study

Enlyte side effect profile equal to placebo

Enlyte has convenient, once a day, small gelcap dose

Patients with preclinicalphase of AD/MildCognitive Impairment

Patients with mild to moderate depression and cognitive decline

Exactly who can benefit from EnLyte?

EnLyte works quickly Onset of action: as little as 1 week

Maximum of 6 weeks

Readily crosses the blood-brain barrier2

The therapeutic effects of antidepressants, such as SSRIs, take 2-3 weeks16

True drug response* is delayed for 2 weeks or more16

Can take up to 3 months to feel the full benefits of an antidepressant17

AdvAnced generAtion folAte therApy

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Patients with Major Depressive Disorder (MDD) who need adjunctive therapy

70% of patients do not achieve remission with a single medication13

The majority of patients do not achieve remission with any initial treatment13

According to the recent APA Practice Guidelines, Considering the modestevidence that supports folate as an augmentation strategy and its attractiverisk-benefit profile, folate can be recommended as a reasonable adjunctivestrategy for major depressive disorder that carries little risk10

Patients with mild to moderate depression and cognitive decline

High levels of homocysteine are associated with cognitive impairment15

EnLyte addresses distinctive nutritional requirements for depressed patientsunder treatment for early memory loss and at risk of hyperhomocysteinemia2

Patients with mild to moderate depression

A double-blind study found L-methylfolate as effective astrazodone (tricyclic antidepressent monotherapy)14

Folate monotherapy may benefit certain patients9

Pregnant women

Category A for pregnancy2

EnLyte may also be an appropiate folate supplement for those at high risk for neural tube defects regardless of their MTHFR polymorphic genotypes2

EnLyte may be taken before conception, throughout pregnancy, and duringthe postnatal period, regardless of lactation status2

I strongly recommend use of EnLyte in women

who are planning to become pregnant or are pregnant.

*As opposed to nonspecific or placebo response.

(POCKET)

Lawrence D. Ginsberg, MD, President and Chief Executive Officer, Red Oak Psychiatry Associates, Houston, TX Written communication

[EnLyte is] the natural, safe thing that addresses the root cause of depression

rather than symptomatic relief. Andrew Farah, MD, Chief of Psychiatry,

High Point Section of UNC Health Care, Central NC June 19, 2013, oral communication

Mild to moderate AD with high homocysteine

DeltaFolateL-methylfolateFolinic acidFolic acidBrain-ready metabolite coenzymesB12 B6 B1

B2 B3 CPhospholipid (phosphatidylserine) conjugatedomega 3s that mimic the structure of fattyacids found in the brainDHA EPABrain-ready mineral metabolites and vitaminsZinc Magnesium Vitamin C

What is EnLyte?

Why does EnLyte work? How does EnLyte work?

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

EnLyte is indicated for depression therapy for patients at risk of folate deficiency as determined by a licensed practitioner; for obstetrics patients who may be at risk of postpartum depression; and as a prescription pre-natal/post-natal vitamin for women at increased risk of having offspring with neural tube defects (NTDs), and who would benefit from advanced folate supplementation.


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EnLyte is that combination of all the cofactors you needengineered to maximize that homocysteine cycle and treat depression.

Pregnancy and lactation

Malabsorption syndromes

Kidney dialysis

Age

Liver disease

Certain types of anemia

Alcohol abuse

Smoking

Certain medications(lamictal and first-generationanticonvulsants, metformin,sulfasalazine, triamterene,methotrexate, barbiturates,oral contraceptives)


Contains the following optimal ingredients2 Why theyre so important

16 mg total folateDeltaFolate

L-methylfolate

Folinic acid

Folic acid

Brain-ready metabolite cofactors

B12B6B1B2B3

Phospholipid (phosphatidylserine) conjugated omega 3s that mimic the structure of fatty acids found in the brain

DHA

EPA

Brain-ready mineral metabolites and vitamins

Zinc

Magnesium

Vitamin C

6(S)-5-MeTHF-magnesium 7 mg

6(S)-5-FormylTHF sodium 3 mg

Citrated folic acid CR 6 mg

5-deoxyadenosylcobalamin 25 mcg

Methylcobalamin 25 mcg

Pure ironamino acid chelate 750 mcg

Organic irongluconate 750 mcg

Pyridoxal 5 phosphate 25 mcg

Thiamine pyrophosphate 25 mcg

Flavin adenine dinucleotide 25 mcg

NADH 25 mcg

PS-DHA 6.4 mg

PS-EPA 800 mcg

Phosphatidylserine 18 mcg

Ascorbates (as magnesium, zinc) 25 mg

L-theronic acid (as metabolite) 1 mg

Trimethylglycine (betaine)

Reduces homocysteine and maximizes production of neurotransmitters by completely addressing the needs of the remethylation and transsulfuration cycles2

60% of the US population have polymorphisms of the MTHFR enzyme and are unable to convertfolate/folic acid into L-methylfolate3,4

Increases the risk of elevated homocysteine levels

Increases the need for folate

An additional 12 polymorphisms related to the reduction of B cofactors put depressed patients at risk5

Other risk factors can increase the need for folate68

EnLyte contains the much-needed B12 cofactorwithout it, L-methylfolate gets caught in the methyl group trap2

Folinic Acid

L-MethylfolateSerotoninDopamine

Norepinephrine

B3 BH4

Zn/MgBH2

B12

B2

B6

Methionine

B12

DMG

Tryptophanhydroxylase

Tyrosinehydroxylase

B1

Betaine

REDUCTION OF HOMOCYSTEINELEVELS

ENHANCEDNEUROTRANSMITTERSYNTHESIS

5-MTHF

PS-DHAEPA

Folic Acid

THF

Converted by MTHFR,which is affected by

C677T polymorphism

DHFR

5-, 10- MTHF

Gluten-free Calcium-free Casein-free

Folic Acid

L-methylfolate

B3

Folinic Acid

B2

B6

B1

B12

Zinc

Artificial dye-free

Brain-ready metabolite coenzymes and mineral cofactors

92% Reduced Folate

MagnesiumBetaine

Omega 3s

Visit Us On Our Website: www.EnlyteRX.com

Patients with or without cognitive decline over 50 with high Hcy or Hcy risk factors

Patients with MCI

Why does EnLyte work? How does EnLyte work?

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

EnLyte is indicated for depression therapy for patients at risk of folate deficiency as determined by a licensed practitioner; for obstetrics patients who may be at risk of postpartum depression; and as a prescription pre-natal/post-natal vitamin for women at increased risk of having offspring with neural tube defects (NTDs), and who would benefit from advanced folate supplementation.


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EnLyte is that combination of all the cofactors you needengineered to maximize that homocysteine cycle and treat depression.

Pregnancy and lactation

Malabsorption syndromes

Kidney dialysis

Age

Liver disease

Certain types of anemia

Alcohol abuse

Smoking

Certain medications(lamictal and first-generationanticonvulsants, metformin,sulfasalazine, triamterene,methotrexate, barbiturates,oral contraceptives)


Contains the following optimal ingredients2 Why theyre so important

16 mg total folateDeltaFolate

L-methylfolate

Folinic acid

Folic acid

Brain-ready metabolite cofactors

B12B6B1B2B3

Phospholipid (phosphatidylserine) conjugated omega 3s that mimic the structure of fatty acids found in the brain

DHA

EPA

Brain-ready mineral metabolites and vitamins

Zinc

Magnesium

Vitamin C

6(S)-5-MeTHF-magnesium 7 mg

6(S)-5-FormylTHF sodium 3 mg

Citrated folic acid CR 6 mg

5-deoxyadenosylcobalamin 25 mcg

Methylcobalamin 25 mcg

Pure ironamino acid chelate 750 mcg

Organic irongluconate 750 mcg

Pyridoxal 5 phosphate 25 mcg

Thiamine pyrophosphate 25 mcg

Flavin adenine dinucleotide 25 mcg

NADH 25 mcg

PS-DHA 6.4 mg

PS-EPA 800 mcg

Phosphatidylserine 18 mcg

Ascorbates (as magnesium, zinc) 25 mg

L-theronic acid (as metabolite) 1 mg

Trimethylglycine (betaine)

Reduces homocysteine and maximizes production of neurotransmitters by completely addressing the needs of the remethylation and transsulfuration cycles2

60% of the US population have polymorphisms of the MTHFR enzyme and are unable to convertfolate/folic acid into L-methylfolate3,4

Increases the risk of elevated homocysteine levels

Increases the need for folate

An additional 12 polymorphisms related to the reduction of B cofactors put depressed patients at risk5

Other risk factors can increase the need for folate68

EnLyte contains the much-needed B12 cofactorwithout it, L-methylfolate gets caught in the methyl group trap2

Folinic Acid

L-MethylfolateSerotoninDopamine

Norepinephrine

B3 BH4

Zn/MgBH2

B12

B2

B6

Methionine

B12

DMG

Tryptophanhydroxylase

Tyrosinehydroxylase

B1

Betaine

REDUCTION OF HOMOCYSTEINELEVELS

ENHANCEDNEUROTRANSMITTERSYNTHESIS

5-MTHF

PS-DHAEPA

Folic Acid

THF

Converted by MTHFR,which is affected by

C677T polymorphism

DHFR

5-, 10- MTHF

Gluten-free Calcium-free Casein-free

Folic Acid

L-methylfolate

B3

Folinic Acid

B2

B6

B1

B12

Zinc

METHYLATESDNA

ENHANCED GLUTATHIONE SYNTHESIS

Homocysteine

Cystathionine

Cysteine

Glutathione

CH3DNA

SAM

Patients with confirmed or suspected MTHFR Polymorphism and or APOE 4 Allele

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