WO2017064098A1 - Produits pour le traitement de troubles de la douleur psychogène - Google Patents

Produits pour le traitement de troubles de la douleur psychogène Download PDF

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Publication number
WO2017064098A1
WO2017064098A1 PCT/EP2016/074417 EP2016074417W WO2017064098A1 WO 2017064098 A1 WO2017064098 A1 WO 2017064098A1 EP 2016074417 W EP2016074417 W EP 2016074417W WO 2017064098 A1 WO2017064098 A1 WO 2017064098A1
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WO
WIPO (PCT)
Prior art keywords
opioid antagonist
use according
icd
disorder
code
Prior art date
Application number
PCT/EP2016/074417
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English (en)
Inventor
Lars Holger Hermann
Original Assignee
Lars Holger Hermann
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Lars Holger Hermann filed Critical Lars Holger Hermann
Publication of WO2017064098A1 publication Critical patent/WO2017064098A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/485—Morphinan derivatives, e.g. morphine, codeine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system

Definitions

  • the present invention relates to the use of naltrexone for the manufacture of a medicament for the treatment of somatoform pain disorder or persistent pain disorder.
  • the medication is characterized by significant reduction of the symptoms.
  • Somatoform pain disorder is a type of psychogenic condition. It is characterized by a subjectively sensed, intense and torturing pain in a part of the body, which lasts for at least six months and cannot be sufficiently explained by a body condition or physiological incidence.
  • General common symptoms of this disease comprise pain (headache, backache), which are associated with fatigue and exhaustion.
  • the disease described herein is the chronic form of the disease, i.e. lasting longer than six months. Frequently, the symptoms change over the progress of the disease, and various, distinct organ systems are affected. It is very characteristic that the symptoms are described inconsistently.
  • the invention recited herein is defined for both ICD-10 codes, F 45.40 persistent somatoform pain disorder, and F 45.41 , chronic pain disorder with somatic and psychological factors.
  • the distinction between these symptomatically identical disease forms is that for F 45.41 , a causative organic correlate may be considered as the cause. However, it becomes independent in a way that it leads to a persistent pain disorder. Therefore, the present invention defines disease patterns, wherein the prevalent symptoms of persistent, strong pains cannot be sufficiently explained by a physiological process or a physical disorder.
  • An emotional conflict or social burdens can be defined, but also an organic correlate, such as in F 45.41 , can be found, which however does not (or not any more) suffice as an explanation, and cause clinically relevant suffering and compromise social, working and other major functional sectors.
  • the pain disorders are diagnosed when organic causes of pain are substantially excluded, or do not suffice to explain the severe duration or type of pains. According to the guideline of ICD-10, there are pains occurring on the majority of days for more than six months, which are severely distressing and without sufficient organic explanation. The attention of the patient must be focused on the disease patterns. Disorders comprising disorders of the schizophrenic type, or the occurrence during an affected or hypochondriac disorder, are considered an exclusive diagnosis.
  • the disease definitions presented herein are based both on the classification according to DSM 4 and 5, as well as on the definitions according to ICD 10.
  • ICD 10 these are diseases of the type of soma- toform pain disorder, ICD 10 F 45.4; according to DSM 4, these are pain disorders associated with psychological factors, 307.80.
  • the present invention is directed to an opioid antagonist for use in the treatment of a somatoform disorder.
  • a somatoform disorder may be a disorder according to ICD-10 code F 45 as described in the background section, e.g. F 45.40 persistent somatoform pain disorder, or F 45.41 , chronic pain disorder with somatic and psychological factors.
  • naltrexone can be used for the treatment of somatoform disorders.
  • other opioid antagonists may be used for this treatment, for example naloxone, 6-alpha-naltrexol, 6-beta- naltrexol, naloxol, naltrexamine or connective tissue activating peptide (CTAP).
  • CTAP connective tissue activating peptide
  • the present invention also provides a pharmaceutical composition, comprising the opioid antagonist for use as described above, and a pharmaceutically acceptable carrier.
  • the present invention provides an opioid antagonist for diagnosing a somatoform disorder according to ICD-10 code F 45, e.g. F 45.40 persistent somatoform pain disorder, or F 45.41 , chronic pain disorder with somatic and psychological factors.
  • a somatoform disorder according to ICD-10 code F 45, e.g. F 45.40 persistent somatoform pain disorder, or F 45.41 , chronic pain disorder with somatic and psychological factors.
  • Still another aspect of the invention relates to a method of treating or preventing a somatoform disorder according to ICD-10 code F 45, e.g. F 45.40 or F 45.41 , comprising administering an effective dose of the opioid antagonist as described above, or the pharmaceutical composition as described above, to a subject in need thereof.
  • Naltrexone mainly occurs in the form of naltrexone hydrochloride salt.
  • the invention comprises the molecule and all physiologically acceptable salts.
  • Naltrexone hydrochloride is preferred based on existing experience.
  • the molecule is a complete antagonist for all opiate receptors, but does not have any opioid properties itself, neither does it produce addiction by itself.
  • naltrexone is resorbed virtually completely. It is subject to the first pass effect. Its half life is about 9 hours.
  • a degradation product is beta-naltrexole, which is also antagonistically active.
  • oral administration is the preferred form of oral administration.
  • intravenous, intramuscular, sublingual, nasal, rectal or transdermal administration is also possible.
  • naltrexone can be used for consecutive every day care.
  • the present invention is directed to an opioid antagonist for use in the treatment of a somatoform disorder according to ICD-10 code F 45.
  • said somatoform disorder is persistent somatoform pain disorder according to ICD-10 code F 45.40 or chronic pain disorder with somatic and psychological factors according to ICD-10 code F 45.41 .
  • the opioid antagonist is for use as above, wherein the subject to be treated has previously been treated with one or more opiates.
  • the opioid antagonist for use as above is selected from the group consisting of naltrexone, naloxone, 6-alpha- naltrexol, 6-beta-naltrexol, naloxol, naltrexamine and connective tissue activating peptide (CTAP).
  • CTAP connective tissue activating peptide
  • said opioid antagonist is naltrexone.
  • the opioid antagonist for use as mentioned above may be administered in the form of a pharmaceutically acceptable salt, preferably hydrochloride.
  • the opiate antagonist may also be provided as a derivative of the above mentioned compounds, such as an ester, as long as the opioid antagonistic effect is not substantially decreased in the body.
  • Such a deri- vate may be converted to the active form within the human body, for example by enzymatic cleavage of the derivatizing moiety.
  • said opioid antagonist is administered in the form of a tablet, plaster, or a sustained release formulation, preferably a tablet.
  • the opioid antagonist may be administered by oral, intravenous, intramuscular, sublingual, nasal, rectal or transdermal administration. Oral administration is particularly preferred.
  • the opioid antagonist may be administered in an amount of 25-100 mg per day, preferably 50 mg per day.
  • it may be administered in an amount of 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95 or 100 mg per day, but higher doses may also be possible, such as 1 10, 120, 130, 140, 150 or 200 mg per day.
  • a physician can routinely determine a suitably adapted dose for a given patient according to established medical practice.
  • the opioid antagonist may be administered either (i) daily or (ii) less frequently than once per day, preferably every 48 hours. It is particularly preferred to administer the opioid antagonist once per day, e.g. every 24 hours or approximately every 24 hours, such as once every 20, 22, 26 or 30 hours.
  • the duration of the treatment session is less than six months, preferably less than two months, such as 4, 5, 6 or 7 weeks.
  • the present invention provides a pharmaceutical composition, comprising the opioid antagonist for use as described above, and a pharmaceutically acceptable carrier.
  • the present invention provides an opioid antagonist for diagnosing a somatoform disorder according to ICD-10 code F 45, e.g. F 45.40 persistent somatoform pain disorder, or F 45.41 , chronic pain disorder with somatic and psychological factors.
  • a somatoform disorder according to ICD-10 code F 45, e.g. F 45.40 persistent somatoform pain disorder, or F 45.41 , chronic pain disorder with somatic and psychological factors.
  • Still another aspect relates to a method of treating or preventing a somatoform disorder according to ICD-10 code F 45, e.g. F 45.40 persistent somatoform pain disorder, or F 45.41 , chronic pain disorder with so- matic and psychological factors, comprising administering an effective dose of the opioid antagonist as described above, or the pharmaceutical composition as described above, to a subject in need thereof.
  • a somatoform disorder according to ICD-10 code F 45 e.g. F 45.40 persistent somatoform pain disorder, or F 45.41 , chronic pain disorder with so- matic and psychological factors
  • the present inventor was consulted in a medical emergency, wherein a patient suffered from an opiate overdose. According to his relatives, the patient had been prediagnosed with a somatoform pain disorder. Due to the current deterioration of the pain symptoms, the patient had increased the opiate dose without consulting the responsible physician. The consequence was an overdose with decreasing breathing rate, cognitive impairment and somnolescence. Since the patient refused to have an injection and was still able to swallow, the patient was given naltrexone orally. The opiate adverse effects ameliorated within 20 minutes.
  • the examples are used as treatment options for somatoform pain disorders with naltrexone.
  • VAS visual analogue scale

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Emergency Medicine (AREA)
  • Neurosurgery (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

La présente invention concerne l'utilisation de naltrexone pour la fabrication d'un médicament pour le traitement d'un trouble de la douleur somatoforme ou d'un trouble de douleur persistante. Le médicament est caractérisé par une réduction importante des symptômes.
PCT/EP2016/074417 2015-10-12 2016-10-12 Produits pour le traitement de troubles de la douleur psychogène WO2017064098A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB1517995.5A GB2543271A (en) 2015-10-12 2015-10-12 Products for treating psychogenic pain disorders
GB1517995.5 2015-10-12

Publications (1)

Publication Number Publication Date
WO2017064098A1 true WO2017064098A1 (fr) 2017-04-20

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PCT/EP2016/074417 WO2017064098A1 (fr) 2015-10-12 2016-10-12 Produits pour le traitement de troubles de la douleur psychogène

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WO (1) WO2017064098A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1992014364A1 (fr) * 1991-02-25 1992-09-03 Conan Kornetsky Recepteur antagoniste opiace modulant les mouvements hypercinetiques anormaux
WO1999045906A1 (fr) * 1998-03-09 1999-09-16 Trustees Of Tufts College Traitement des comportements compulsifs chez l'homme et l'animal
US20130197015A1 (en) * 2009-12-22 2013-08-01 Pondera Biotechnologies, LLC Novel method to improve the safety and efficacy of caffeine
WO2014170352A1 (fr) * 2013-04-17 2014-10-23 H. Lundbeck A/S Nalméfène pour le traitement de patients atteints de trouble de l'anxiété

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6897242B1 (en) * 1999-02-24 2005-05-24 Judson J. Somerville Non-racemic mixtures of d- and l- methadone and method of treating pain

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1992014364A1 (fr) * 1991-02-25 1992-09-03 Conan Kornetsky Recepteur antagoniste opiace modulant les mouvements hypercinetiques anormaux
WO1999045906A1 (fr) * 1998-03-09 1999-09-16 Trustees Of Tufts College Traitement des comportements compulsifs chez l'homme et l'animal
US20130197015A1 (en) * 2009-12-22 2013-08-01 Pondera Biotechnologies, LLC Novel method to improve the safety and efficacy of caffeine
WO2014170352A1 (fr) * 2013-04-17 2014-10-23 H. Lundbeck A/S Nalméfène pour le traitement de patients atteints de trouble de l'anxiété

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
CHERRY D A ET AL: "Diagnostic epidural opioid blockade and chronic pain: Preliminary report", PAIN, ELSEVIER SCIENCE PUBLISHERS, AMSTERDAM, NL, vol. 21, no. 2, 1 February 1985 (1985-02-01), pages 143 - 152, XP024381750, ISSN: 0304-3959, [retrieved on 19850201], DOI: 10.1016/0304-3959(85)90284-2 *

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GB2543271A (en) 2017-04-19
GB201517995D0 (en) 2015-11-25

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