Physician Therapeutics is a specialty pharmaceutical company that develops and distributes proprietary prescription metabolic products to physicians and their patients in the United States. The Company’s products address the nutrient requirements associated with specific disease states and can be used safely as stand alone products, or in combination with traditional prescription drugs for the dietary management of disease. These products are regulated by the Food and Drug Administration (FDA) as Medical Foods, defined in the Orphan Drug Act {Section 5(5) of the Orphan Drug Act (21 U.S.C. 360ee (b)}. All products are available only by prescription, and while the patient is under the ongoing care of a physician.
These prescription metabolic products represent a novel approach to management of certain disease states, focusing on safety and efficacy without the deleterious side effects of traditional prescription drugs. By addressing the underlying nutritional requirements and metabolic disruptions that are associated with a particular disease, our products are effective in the dietary management of specific disease states.
Related: Message from Physician Therapeutics' CEO
Medical Food Products
Theramine™
Theramine™ provides the neurotransmitter precursors to the neuronal messengers that control pain and inflammation. Theramine™ is designed to manage the nutritional deficiencies associated with acute and chronic pain syndromes, including fibromyalgia.
GABAdone™
GABAdone™ provides the amino acids that are precursors to the neurotransmitters associated with restorative sleep and anxiety. GABAdone™ is designed to provide specific dietary management of disorders associated with the inability to fall asleep or remain asleep.
Sentra PM™
Sentra PM™ provides the amino acids that are precursors to the neurotransmitters that control restorative sleep. Sentra PM™ is designed to provide for specific dietary management of the nutritional deficiencies associated with sleep disorders. Sentra PM™ provides the neurotransmitter precursors for serotonin and acetylcholine. Sentra AM™ is used along with Sentra PM™ and Theramine™ to manage the nutritional deficiencies associated with fibromyalgia.
Sentra AM™
Sentra AM™ provides the amino acid precursors for the neurotransmitter precursor acetylcholine. Sentra AM™ is designed to provide dietary management for conditions associated with fatigue and cognitive dysfunction .
Hypertensa™
Hypertensa™ provides the amino acids that are precursors for the neurotransmitters nitric oxide and acetylcholine. Hypertensa™ also provides nutrient support for the production of nitric oxide by peripheral vessels by specific stimulation of the constitutive nitric oxide synthetase (cNOS). Hypertensa™ is designed to provide nutritional support for the specific deficiencies associated with hypertension.
Trepadone™
Trepadone™ is a Medical Food formulated to be used by practicing physicians for the nutritional management of pain and inflammation syndromes, particularly associated with arthritis. Trepadone™ helps to modulate neurotransmitters involved in acute and chronic pain including nitric oxide, GABA, serotonin, and brain histamine. Trepadone™ helps modulate inflammation through fish oil fatty acids. Trepadone™ also addresses joint function with chondroitin sulfate and glucosamine.
AppTrim™
AppTrim™ provides the amino acids that are precursors to the neurotransmitters norepinephrine, epinephrine, serotonin and acetylcholine. AppTrim™ is designed to provide the dietary management of the specific nutrient deficiencies associated with insulin resistance and obesity.
Medical Food and Generic Drug Convenience Packs for The Management of Nutritional Requirements in Disease States
There has been increasing attention to the role that neurotransmitters and neuromodulators play in various aspects of health and disease. Neurotransmitters are the chemical messengers that allow one neuron to communicate with other neurons or effector organs. Some examples of classic neurotransmitters are acetylcholine and norepinephrine that function within the autonomic nervous system. The autonomic nervous system, operating through its neurotransmitters, controls important body functions, such as heart rate, respiratory rate, gastrointestinal function, appetite, sleep, sexual performance, blood pressure, and mood. Additionally, neurotransmitters and neuromodulators play a crucial role in regulating the function of the cardiovascular, reproductive, musculoskeletal, immune, respiratory, and memory systems.
Numerous pharmaceutical agents have been developed that exert their effects by interfering with one or more of these neurotransmitter or neuromodulator systems. One important pharmaceutical mechanism is that of reuptake inhibition of neurotransmitters in the synaptic cleft of neuron junctions. The pharmaceuticals fluoxetine and fenfluramine are examples of neurotransmitter reuptake inhibitors.
All known neurotransmitters are synthesized within the neurons from their requisite precursor molecules. In addition, administration of neurotransmitter and neuromodulator precursors to subjects has long been known to induce a physiologic response when initially administered. For example, administration of tryptophan – the precursor to the neurotransmitter serotonin – leads to the production of serotonin, administration of choline leads to the production of acetylcholine, administration of tyrosine leads to the production of epinephrine, and administration of arginine leads to the production of nitric oxide. These precursor molecules are generally amino acids and are produced in the liver or are derived from the diet.
Although, the administration of neurotransmitter precursors is known to acutely produce neurotransmitters, as evidenced by a physiologic response, the physiologic response induced by administration of a precursor to a neurotransmitter is often inconsistent, weak in magnitude, and attenuates rapidly such that the precursor administration is largely ineffective. The physiologic loss of neurotransmitter function results in abnormal physiology that either initiates a disease or promotes its severity.
The following examples illustrate formulations that produce the desired effect with the lowest FDA approved dose of a pharmaceutical agent.
THERAPROXEN™ CONVENIENCE PACK
THERAPROXEN is a convenience pack that includes Theramine and naproxen. In this dual management system, Naproxen is administered as 250 mg daily while Theramine is administered twice daily. Naproxen used alone, treats pain and inflammation and is often used as frequently as four times per day. Theramine is used to manage the increased nutritional requirements associated with pain syndromes. THERAPROXEN is a management system that includes a pharmaceutical agent to treat pain and inflammation and a Medical Food to manage the associated nutritional requirements. In a clinical crossover study of patients with knee pain associated with arthritis, THERAPROXEN reduced pain in a manner comparable to the use of naproxen alone in four daily doses.
THERAMINE™ MEDICAL FOOD
Theramine is Medical Food specifically formulated to produce GABA, ACTH, serotonin, nitric oxide, and acetylcholine in order to reduce inflammation and ameliorate both acute and chronic pain. It includes GABA, arginine, choline, glutamine, grape seed extract, cocoa, cinnamon, histidine, serine, 5-HTP, and hydrolyzed whey protein. Theramine is formulated to directly inhibit pain neurons while inducing the neurotransmitters nitric oxide and serotonin. In addition, Theramine is designed to induce production of ACTH and cortisol to reduce inflammation. The dosage is two capsules that can be taken up to four times daily. Theramine is formulated in specific proportions to manage the nutritional requirements of patients with pain and inflammation.
PRAZOLAMINE™ CONVENIENCE PACK
PRAZOLAMINE is a convenience pack that includes Theramine and carisoprodol. In this dual management system, carisoprodol is administered as 350 mg daily while Theramine is administered as two capsules once daily. Both Theramine and carisoprodol are administered at bedtime in the dual management system. Carisprodol used alone, treats back pain and spasm and is often used as frequently as three times per day. Theramine is used to manage the nutritional deficiencies associated with pain syndromes. PRAZOLAMINE is a management system that includes a pharmaceutical agent to treat back pain and inflammation, and a Medical Food to manage the associated nutritional deficiency. In a clinical crossover study of patients with back pain, PRAZOLAMINE reduced back pain more effectively than carisoprodol used alone.
LYTENSOPRIL™ CONVENIENCE PACK
LYTENSOPRIL is a convenience pack that includes Hypertensa and lisinopril. In this dual management system, lisinopril is administered as 20 mg daily while Hypertensa is administered once daily. LYTENSOPRIL used alone, treats hypertension and is often used as frequently as twice a day. Hypertensa is used to manage the nutritional deficiencies associated with hypertension. LYTENSOPRIL is a dual management system that includes a pharmaceutical agent to treat hypertension and a Medical Food to manage the associated nutritional deficiency. In a clinical crossover study of patients with hypertension, LYTENSOPRIL reduced blood pressure more effectively than lisinopril used alone.
When lisinopril was used to treat hypertension, a modest reduction of blood pressure occurred. When the underlying nutritional deficiency was addressed with Hypertensa, a further reduction of blood pressure occurred. This was a clinical crossover trial. The blood pressure was measured 15 days after initiation of administration.
HYPERTENSA™ MEDICAL FOOD
Hypertensa is a Medical Food specifically formulated to increase nitric oxide and acetylcholine. The Hypertensa formula includes choline, arginine, histidine, leucine, hawthorn berry, ginseng, cocoa, caffeine, dextrose, and cinnamon. The total dose is divided into two capsules. The dosage is two capsules, twice daily. The convenience packed combination includes lisinopril, 20 mg daily.
TRAZAMINE™ CONVENIENCE PACK
TRAZAMINE is a convenience pack that includes Sentra PM and trazadone. In this dual management system, trazadone is administered as 50 mg at bedtime while Sentra PM is administered once daily at bedtime. Trazadone used alone, treats insomnia and is often used at a dose of 100 mg twice daily. Sentra PM is used to manage the nutritional deficiencies associated with insomnia and sleep latency insomnia. TRAZAMINE is a dual management system that includes a pharmaceutical agent to treat insomnia and a Medical Food to manage the associated nutritional deficiency. In a clinical crossover study of patients with insomnia TRAZAMINE reduced sleep latency and increased duration of sleep when compared to trazadone used alone.
SENTRA PM MEDICAL FOOD
Sentra PM is a Medical Food specifically formulated to produce acetylcholine and serotonin to aid in the induction and maintenance of sleep. Sentra PM contains choline, acetylcarnitine, 5-hydroxytryptophan, ginkgo biloba, glutamic acid, cocoa, and dextrose. The total dose is divided into two capsules. The Medical Food is co-packed with the pharmaceutical temazepam to reduce sleep latency and prolong duration of restful sleep.
SENTRA PM MEDICAL FOOD
Sentra PM is a Medical Food specifically formulated to produce acetylcholine and serotonin to aid in the induction and maintenance of sleep. Sentra PM contains choline, acetylcarnitine, 5-hydroxytryptophan, ginkgo biloba, glutamic acid, cocoa, and dextrose. The total dose is divided into two capsules. The Medical Food is co-packed with the pharmaceutical temazepam to reduce sleep latency and prolong duration of restful sleep.
SYNOPHYLLINE™ CONVENIENCE PACK
SYNOPHYLLINE is a convenience pack that includes Sentra AM and theophylline. In this dual management system, theophylline is administered as 25 mg daily while Sentra AM is administered once daily. Theophylline, used alone, treats cognitive function and fatigue and is often used at a dose of 100 mg per day. Sentra AM is used to manage the nutritional deficiencies associated with fatigue, cognitive awareness, and concentration. SYNOPHYLLINE is a dual management system that includes a pharmaceutical agent to treat fatigue and a Medical Food to manage the associated nutritional deficiency. In a clinical crossover study of patients with fatigue, SYNOPHYLLINE reduced daytime fatigue, morning grogginess and increased alertness.
SENTRA AM MEDICAL FOOD
SENTRA AM is a Medical Food specifically formulated to produce acetylcholine and glutamate. Sentra AM contains choline, acetylcarnitine, ginkgo biloba, glutamic acid, cocoa, and dextrose. The total dose is divided into two capsules. Sentra AM is used to enhance cognitive awareness and eliminate daytime fatigue.
CONCLUSIONS
The nutritional management of disease states gives physicians additional flexibility in the use of pharmaceutical agents. Convenience packed Medical Foods with specific pharmaceutical agents increases the efficiency of pharmaceutical treatment and reduces drug side effects.
- Nutrition in Health and Disease
- Metabolic Process of Chronic Diseases
Physiological Effects of Nutrients
Nutrients are required to drive the basic physiological activities that sustain life. Nutrients function in diverse roles as energy sources; coenzymes and cofactors in enzyme systems; structural components of cell membranes; hormone effectors; precursors of biologically active molecules that include eicosanoids, neurotransmitters and nucleic acids; initiators and modulators of metabolic activity; determinants of membrane electrochemical potential; regulators of differentiation of epithelial cells and osteocytes; and a broad spectrum of other cellular activities. Nutrients may also be involved in less well-defined roles such as in membrane receptor synthesis and activity and inflammatory responses, and as promoters and inhibitors of gene expression and cell replication.
If nutrient intakes are not sufficient to adequately support these basic physiological activities, adaptive mechanisms are triggered to conserve the available nutrient supply. Among these mechanisms are increased efficiency of intestinal absorption, enhanced renal reabsorption, adjustment of metabolic rate, and a compensatory shift to ancillary pathways that minimize nutrient demand. Although effective as temporary corrective measures, these adaptive responses will begin to lose effectiveness over time if inadequate intakes are not corrected.
Nutrient deficiencies may be classified as absolute or relative. Absolute deficiencies are caused by chronic inadequate consumption of nutrients that eventually results in depletion of reserves. Depleted nutrient reserves leave cells vulnerable to daily fluctuations in nutrient intakes or to sudden increases in demand that occur with unintended exposure to environmental stressors such as pathogens, chemical irritants, and oxygen free radicals, or to cellular injury from infection or trauma. Relative deficiencies can occur even if nutrients are consumed in adequate amounts to meet basic physiological requirements and maintain reserves, when these intakes are not sufficient to satisfy increases in metabolic demand.
Effects of Nutrients in Disease
The effects of nutrients in disease are the result of support for activities that impede or reverse the progression of cellular pathology and physiology. All innate cellular functions, defenses, and repair systems require a continuous supply of nutrients provided by nutrient reserves to make up the shortfall as dietary intakes fluctuate. Among the critical nutrient-dependent cellular defenses are free radical and cellular antioxidant enzymes, acute inflammatory responses, phagocytic and bactericidal activity, lymphocyte activation and proliferation, humoral and cell-mediated immunity, and the initiation and promotion of the coagulation cascade. Additional defensive roles supported by nutrients involve protein synthesis, reversal and repair of DNA and chromosomal damage, integrity of immune cell structure and function, and a whole host of other activities at the molecular level.
Nutrients function in disease by mechanisms that differ substantially from those of pharmacologic agents. Nutrients will modify nutrient fluxes and metabolic activities that are part of normal cellular processes whereas drugs will bind to membrane receptors and inhibit their activity to alter cell responsiveness. Nutrient requirements in the presence of disease are considerably higher than those that have been established to prevent the symptoms of the classic deficiency diseases. These requirements can increase incrementally by as much as 10 to more than 100 times the usual amounts. At these levels of intake, the roles for most nutrients are expanded to include functions that are not typically observed at physiological intakes. The higher requirements for nutrients in disease are needed to support the accelerated rate of metabolic activity that cellular systems demand in order to reduce the potential for permanent damage from the pathophysiological processes associated with the disease.
Metabolic Burden of Nutrient Imbalances
Nutrient imbalances may be linked to initiation and/or exacerbation of virtually all diseases. These imbalances can be caused by either deficiencies or excesses of one or more nutrients. Excesses can sometimes contribute to relative deficiencies by increasing demand for supporting nutrients to accommodate the increased rates of metabolism required for disposal of the nutrient surplus. Nutrient deficiencies most often involve inadequate intakes of vitamins, minerals and omega -3-fatty acids, and ingestion of low quality protein. Nutrient excesses most often involve overconsumption of energy, fat, saturated fat, omega-6 fatty acids, and cholesterol. Both types of nutrient imbalances can occur simultaneously from habitual consumption of diets high in energy and fat that provide low quality protein and are depleted of vitamins and minerals.
Nutrient imbalances impose a metabolic burden on all organ systems, with the greatest burden on those systems responsible for achieving and maintaining metabolic equilibrium. Long-term disruption of metabolic equilibrium will most often adversely impact the cardiovascular, pulmonary, renal, gastrointestinal, or musculoskeletal systems. In the absence of an adequate supply of nutrients to satisfy normal physiological requirements or adjust to increased metabolic demand, compensatory mechanisms involving one or more of these systems must be initiated to re-establish homeostasis. As with metabolic adjustments to address short-term nutrient deficiencies, these compensatory responses are important for correction of temporary imbalances, but if sustained over the long term, they may become maladaptive and contribute to the degenerative changes responsible for development or worsening of chronic diseases.
Compensatory Responses to Nutrient Imbalances
The primary objective of compensatory responses to nutrient imbalances is to re-establish physiological homeostasis. An example of a compensatory response to an excess intake is the increased secretion of insulin following ingestion of a meal high in rapidly digested and absorbed carbohydrate (high glycemic index foods). Over the short-term, this elevation in insulin is maintained until postprandial blood glucose is restored to fasting levels, usually within a few hours after the meal. When large amounts of high glycemic index foods are repeatedly consumed throughout the day, the postprandial insulin response is sustained for longer periods which will eventually promote the downregulation of insulin receptors that contributes to glucose intolerance. The compensatory response to consumption of large amounts of fat follows a similar path. Elevated postprandial triglyceride levels require secretion of large amounts of chylomicrons to transport the triglyceride load from the intestines to the liver where it is deposited, leaving behind a high concentration of chylomicron remnants. These particles are highly atherogenic with effects on arterial plaque formation similar to those of low density lipoproteins (LDL).
Other examples of compensatory responses to nutrient imbalances involve homeostatic adjustments to maintain body pools of nutrients such as what is observed when sodium intakes are excessive and when calcium intakes are inadequate. If the amount of sodium ingested exceeds renal capacity for elimination, plasma volume will expand until the excess amounts are excreted and sodium homeostasis is re-established. A temporary expansion of plasma volume triggers a compensatory increase in resistance of the peripheral microvasculature in order to maintain a steady rate of vascular perfusion through these tissues. A sustained expansion of plasma volume caused by continuous intakes of excess sodium that overwhelm renal elimination capacity may transform the compensatory increase in peripheral resistance to an increase in blood pressure and establishment of essential hypertension.
The compensatory response to imbalances in calcium homeostasis is initiated by intakes that are not sufficient to maintain plasma calcium levels. Since a critical level of calcium in plasma is an absolute requirement for normal neuromuscular activity, coagulation, and other calcium-dependent activities, short-term deficiencies in calcium intake will trigger the release of calcium from labile skeletal reserves. When these labile reserves are depleted by failure to adjust calcium consumption, bone mineral mass will be sacrificed to release structural calcium into circulation to prevent the plasma concentration from decreasing below critical levels.
Implications of Subclinical Nutrient Deficiencies
Clinical assessment of nutritional status has long been exclusively focused on detection of absolute nutrient deficiencies by relying on clinical evidence of signs and symptoms of classic deficiency states. Yet relative nutrient deficiencies due to disease are equally important, as is the detection of nutrient imbalances before clinical evidence of deficiency is present. At the point where altered cell function has evolved into clinical manifestations of nutrient deficiency, cellular activity will have been compromised for some time and the compensatory responses that might have allowed a temporary adjustment to the deficiency would no longer be effective. Detection of subclinical changes in cell processes early in the course of a nutrient deficiency when cell damage is minor and more readily reversible can have a considerable impact on prevention and treatment of disease. If subclinical deficiency is not corrected, then prolonged marginalization of cellular activity may not only increase vulnerability to disease, but also exacerbate progression of existing disease and interfere with effectiveness of treatment, since all drugs require some level of metabolic support to achieve their desired therapeutic effects.
Nutrient Requirements of Disease States
The involvement of nutrients in cellular defense and repair systems suggests that nutrient requirements must be modified by pathology. In disease, nutrient-dependent activities are expanded to include effects that enhance cellular responsiveness to treatment and accommodate accelerated rates of metabolic activity. Although specific nutrient requirements for different diseases have not been established, they may be imputed from current knowledge of the chemical, physical and biological properties of each nutrient, the nature of the disease, the tissues involved, the type of treatment indicated, and the cellular activities targeted by the treatment.
Neurotransmitters are a class of compounds derived from amino acid precursors that target specific cells to elicit a response to a particular effector molecule. These effector molecules may be a nutrient, a hormone, a nucleotide, an enzyme, a drug, an immunoreactive substance, an inflammatory mediator, or any other substance that has the ability to evoke a cellular response. The neurotransmitters that have been identified and characterized to date are serotonin, nitric oxide, brain histamine, gamma-amino butyric acid (GABA), acetylcholine, dopamine, and norepinephrine. These neurotransmitters are derived from tryptophan, arginine, histidine, glutamic acid, choline, and tyrosine (dopamine and norepinephrine), respectively. Each neurotransmitter will act on a specific target cells. In the presence of disease, the increased demand for neurotransmitters cannot be satisfied by consuming amounts of precursors from dietary sources alone. Supplementation may be needed to prevent relative deficiencies of these amino acid precursors that will ensure that sufficient amounts of neurotransmitters produced are to promote a robust response to treatment and support the processes of healing and recovery.
- GRAS Status
- Scientific & Medical Research
- Clinical Trials
GRAS (Generally Recognized as Safe) Requirements
GRAS is a strict safety standard established by FDA, requiring technical demonstration of non-toxicity and safety, as well as a general recognition and agreement by experts that the ingredients are safe for consumption. Many ingredients have been determined by FDA to be GRAS, and are listed as such by regulation, in Volume 21 Code of Federal Regulations (CRF) Sections 182, 184, and 186. Other ingredients may achieve self-affirmed GRAS status via a panel of independent experts in the pertinent field who co-authors a GRAS report. Several ingredients have been specifically permitted by FDA as safe Medical Foods ingredients, e.g. Folic acid, in Volume 21 CFR Section 172.345(f). Some experts believe that achieving GRAS status is an even higher standard of safety than the standard applied to prescription drugs where a given compound is considered safe for a specific indication in a particular patient population at a specified dose, for a specified period of time. Dietary supplement, OTC drugs, and prescription drugs are not required to have GRAS ingredients. All Physician Therapeutic products ingredients have been safely consumed by widespread populations for long periods of time.
GRAS (Generally Recognized as Safe) Requirements
- Product Availability
- Reimbursement
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- Trial Results
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