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Methods for chronic pain management and treatment using hcg

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Methods for chronic pain management and treatment using hcg


A gonadotropin is administered within a surprisingly effective narrow range for the purpose of treating chronic pain or other central sensitization sequelae. In one aspect, a recipient is provided with at least one of human chorionic gonadotropin (uHCG and/or rHCG), a pharmaceutically active HCG analogue, and a pharmaceutically active metabolite of the HCG or analogue at a dosage selected to provide, or be equivalent to, a human subcutaneous dosage of between 120 IU/day and 170 IU/day of HCG, and more preferably between 140 IU/day and 160 IU/day of HCG. A kit is also described, which includes a supply of the HCG-related drug, a delivery device, and a label that identifies chronic pain or central sensitization as an indication of the drug.
Related Terms: Chorionic Gonadotropin Chronic Pain Gonadotropin Human Chorionic Gonadotropin Pain Management Sensitization

Browse recent Neuralight Hd, LLC patents - Incline Village, NV, US
Inventors: Edson Conrad Hicks, JR., Constance T. Dutton
USPTO Applicaton #: #20120265129 - Class: 604 92 (USPTO) - 10/18/12 - Class 604 
Surgery > Means For Introducing Or Removing Material From Body For Therapeutic Purposes (e.g., Medicating, Irrigating, Aspirating, Etc.) >Treating Material Introduced Into Or Removed From Body Orifice, Or Inserted Or Removed Subcutaneously Other Than By Diffusing Through Skin >Means For Intermixing Liquid With Solid Or Different Liquid >Solid Dissolved In Liquid



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The Patent Description & Claims data below is from USPTO Patent Application 20120265129, Methods for chronic pain management and treatment using hcg.

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This application is a continuation-in-part of U.S. patent application Ser. No. 13/211,101 filed Aug. 16, 2011 and also claims the benefit of priority to U.S. Provisional Application No. 61/475,908, filed Apr. 15, 2011, each of which is incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

The field of the invention is chronic pain management, and more specifically to administration of specific low doses of human chorionic gonadotropin (HCG).

BACKGROUND

An ongoing and pervasive problem in the medical community is treating patients with chronic pain syndromes. It is well recognized today that chronic pain is fundamentally different from acute pain, also referred to as nociceptive pain, which pain results from a mechanical, chemical, metabolic or inflammatory insult.

It has been recognized by some that since the mechanisms and pathways for chronic and acute pain are physiologically different, they require different approaches for treatment. Unfortunately, many in the medical community continue to treat patients suffering from chronic pain syndromes with agents designed to address acute nociceptive pain pathways. Such methods are often fraught with toxicity and dependence issues, and in the end are generally unsatisfactory in ending pain and/or improving quality of life. A new diagnostic paradigm and treatment protocol is therefore needed to address chronic pain.

Central sensitization is a newly recognized diagnostic entity that underlies a broad range of phenotypic syndromes, including various chronic pain and mood disorders. As used herein, central sensitization means an abnormal state of functioning of the neurons and circuitry of the central pain intensity, perception and modulation systems; due to synaptic, chemical, functional and/or structural changes, in which pain is no longer coupled, as acute nociceptive pain is, to particular peripheral stimuli. Instead, the central nervous system (CNS) initiates, maintains and contributes to the generation of pain hypersesensitivity and perception, absent a peripheral stimulus. As used herein, therefore chronic pain and central sensitization represent an overlapping constellation of diagnostic conditions and syndromes.

The present inventors consider the following to be a non-exhaustive listing of conditions associated with (causative or resulting from) central sensitization, each of which is thought to be applicable to humans or other vertebrates.

1. Autonomic neuropathies 2. Chronic back pain 3. Chronic joint pain associated metabolic neuropathy 4. Chronic joint pain associated with inflammation

5. Fibromyalgia

6. Irritable bowel syndrome

7. Migraine

8. Neuropathic pain

9. Osteoarthritis

10. Post Herpetic neuralgia 11. Post surgical pain syndromes

12. Post Traumatic Stress Disorder Pain Syndrome

13. Rheumatoid, arthritic, psoriatic and other chronic arthropathies 14. Spinal nerve compression syndromes associated with neoplasia and/or disc herniation 15. Trigeminal neuralgia 16. Vulvodynia syndrome

Central sensitization is currently thought to be established via a well characterized constellation of cellular changes termed, neuroplasticity. Neuroplasticity consists of the physical remodeling of neuronal and microglial cytoarchitecture; such as changes in synaptic gap junctions, membrane excitability shifts due to ion channel modulation, and gene transcription. Neuroplasticity changes can be bi-directional. In other words, appropriately functioning cells can undergo remodeling that results in a dysfunctional operating state creating the ‘disease states’ of chronic pain and mood disorders. Conversely, these neuroplasticity mediated dysfunctional changes can be reversed with a return to ‘normal’ functioning, which can correspond clinically to a resolution of a ‘disease’ state.

Central sensitization involves, in part, shifts in gene transcription involved in nociception and pain modulation. Huber, et al has clearly shown this phenomenon occurring at specific HCG concentration levels in endometriotic tissue (1). Some of the specific genes identified in this study were genes encoding for G-protein coupled receptor (GPCR) function (2). See: 1. Huber A, Hudelist G, Knofler N, Saleh L, Huber J C, Singer C F. Effect of highly purified human chorionic gonadotropin preparations on the gene expression signature of stromal cells derived from endometriotic lesions: potential mechanisms for the therapeutic effect of human chorionic gonadotropin in vivo. October 2007 Fertility and Sterility Vol. 88, No. Suppl 2. 2. Foukes T, Wood J N. Pain Genes. PLoS Genetics. July 2008 (4)7:e1000086.

These and all other extrinsic materials discussed herein are incorporated by reference in their entirety. Where a definition or use of a term in an incorporated reference is inconsistent or contrary to the definition of that term provided herein, the definition of that term provided herein applies and the definition of that term in the reference does not apply.

Pain, in general, represents a hyper-excitatory state of neuronal tissue associated with an increase in action potential firing. Action potential generation is the result of increased amplitude and/or frequency of electrical signaling. This is created by the cellular integration of changes in molecular signaling, ion gradients and gene expression resulting in the perception of acute or chronic discomfort.

Pain transmission and modulation through the central nervous system network of neurons and support glial cells (microglia and astrocytes) is largely under the control of a large family of cellular receptors known as G protein-coupled receptors (GPCRs). The function of these complex transmembrane receptors is to transduce extracellular stimuli into intracellular signaling including gene transcription. GPCRs modulate and/or mediate virtually all physiologic processes in eukaryotic organisms, including acute and chronic pain. An estimated 90% of all known GPCRs are expressed in the central nervous system. 80% of the currently proposed GPCR families have a known role in modulation of pain. Similarly, most of the identified genes associated with pain modulation are GPCR related genes. Stone L S, Molliver D C. In search of analgesia: Emerging role of GPCRs in pain. Molecular Interventions. 2009 (9):5; 234-251. The LH/HCG receptor is a GPCR. Id.

The LH/HCG receptor complex specifically has been specifically shown to complex with the Gαi/o group resulting in modulation of neurotransmission. Hu L, Wada k, Mores N, Krsmanovic L Z, Catt K J. Essential role of G protein-gated inwardly rectifying potassium channels in gonadotropin-induced regulation of GnRH neuronal firing and pulsatile neurosecretion. Jour Biol Chem. 2006:281(35); 25231-25240.

Gαi/o proteins mediate the widespread inhibitory effects of many neurotransmitters and they mediate the effects of almost all analgesic GCPR agonists. Stone L S, Molliver D C. In search of analgesia: Emerging role of GPCRs in pain. Molecular Interventions. 2009 (9):5; 234-251.

Due to the multiplicity of pathways involved in establishing central sensitization, chronic pain is a complex phenomenon that can be difficult to treat with single-pathway-active-agent therapy. See Latremoliere A, Woolf C J. Central sensitization: A generator of pain hypersensitivity by central neural plasticity. J Pain. 2009 September; 10(9): 895-926.

This may explain why there remains a critical dearth of effective medical interventions to treat chronic pain disorders. Traditional pharmaceutical approaches generally deal with a single involved pathway, which tends to yield less than ideal results and is often associated with significant toxicity. For example, the treatment options most commonly investigated to date consist of centrally acting drugs. These include ketamine, dextromethorphan, gabapentin, pregabalin, duloxetine, milnacipran, lamotrigene; and not all of these have reached human trials at this time. Each has demonstrated a poor therapeutic index in trials.

Thus, there is still a need for apparatus, systems, and methods for treating chronic pain, and more generally central sensitization that approaches this disorder in a pleiotropic fashion.

SUMMARY

OF THE INVENTION

The inventive subject matter provides apparatus, systems, and methods in which a gonadotropin is administered within a surprisingly effective narrow range for the purpose of treating chronic pain or other central sensitization sequelae in a pleiotropic manner.

In one aspect, contemplated methods involve communicating with a subject, person, non-human animal, or other recipient to determine whether that recipient suffers from chronic pain, and then facilitating the recipient\'s taking of at least one of human chorionic gonadotropin (HCG), a pharmaceutically active HCG analogue, and a pharmaceutically active metabolite of the HCG or analogue. Preferably, the dosage is selected to provide, or be equivalent to, a human subcutaneous dosage of between 120 IU/day and 170 IU/day of HCG. More preferably, the dosage is selected to provide, or be equivalent to, a human subcutaneous dosage of between 140 IU/day and 160 IU/day of HCG.

Contemplated manners of communication include procuring a written and/or oral symptom history, performing physical examination, referring for laboratory tests and other studies, and especially focusing on whether the recipient has one or more of fibromyalgia, irritable bowel syndrome, chronic back pain, chronic arthropathy, inflammatory pain, post herpetic neuralgia, trigeminal neuralgia, neuropathic pain, vulvodynia and migraine. Such communication can be performed synchronously between a health care professional and the recipient, as for example in a doctor\'s office or over the phone, and/or asynchronously, as for example using physical mail, electronic mail, and so forth. It is also contemplated to conduct a physical test that aids in distinguishing between nociceptive pain and central sensitization that the recipient may have.

Contemplated manners of facilitating the recipient\'s taking of the drug(s) include administering the drug(s), issuing a prescription for the drug(s), suggesting use of the drug(s), as in a book or article, and/or providing the recipient (directly or indirectly) with contact information for a supply of the drug(s). It is contemplated that one or more of the drugs could be self-administered by the recipient.

The drug(s) are preferably taken as a monotherapy for the central sensitization, but could be combined with other drugs and/or non-drug treatments, including for example, lifestyle changes such as elimination diet, and anti-inflammatory diet. It is preferred that the drug(s) is/are taken in the absence of concurrent opioid pain treatment, and in the absence of concurrent treatment with another gonadotropic substance.

In some instances, a clinician or other provider may have been administering or recommending HCG for some other purpose, or in some other dosage, not realizing that HCG can be effective to ameliorate chronic pain or central sensitization as claimed herein. In such instances it is contemplated that the provider receive information that HCG may have a peak effect on central sensitization between 120 IU/day and 170 IU/day, inclusive, and can thereafter administer or recommend HCG, a pharmaceutically active HCG analogue, or a pharmaceutically active metabolite of the HCG or analogue as claimed herein.



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Key IP Translations - Patent Translations


stats Patent Info
Application #
US 20120265129 A1
Publish Date
10/18/2012
Document #
13311250
File Date
12/05/2011
USPTO Class
604 92
Other USPTO Classes
514/98, 424 45, 604207, 604187
International Class
/
Drawings
3


Chorionic Gonadotropin
Chronic Pain
Gonadotropin
Human Chorionic Gonadotropin
Pain Management
Sensitization


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