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WO2007033400A1 - Procédé de traitement de la douleur chez des patients - Google Patents

Procédé de traitement de la douleur chez des patients Download PDF

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Publication number
WO2007033400A1
WO2007033400A1 PCT/AU2006/001082 AU2006001082W WO2007033400A1 WO 2007033400 A1 WO2007033400 A1 WO 2007033400A1 AU 2006001082 W AU2006001082 W AU 2006001082W WO 2007033400 A1 WO2007033400 A1 WO 2007033400A1
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WO
WIPO (PCT)
Prior art keywords
patient
pain
dose
administered
cancer
Prior art date
Application number
PCT/AU2006/001082
Other languages
English (en)
Inventor
Odette Spruyt
Simon Wein
Vina Nguyen
Alvin Milner
Julia Fleming
Original Assignee
Medical Developments International Limited
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
Priority claimed from AU2005904099A external-priority patent/AU2005904099A0/en
Application filed by Medical Developments International Limited filed Critical Medical Developments International Limited
Priority to AU2006294396A priority Critical patent/AU2006294396A1/en
Priority to EP06827973A priority patent/EP1922063A4/fr
Publication of WO2007033400A1 publication Critical patent/WO2007033400A1/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
    • A61K31/075—Ethers or acetals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P23/00—Anaesthetics
    • 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
    • A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
    • 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
    • A61P25/04—Centrally acting analgesics, e.g. opioids

Definitions

  • the present invention relates to methods of treating pain in patients. It has particular, application to methods involving the use of methoxyflurane to treat pain in patients.
  • Methoxyflurane (2,2-dichloro- 1 ,1-difluoroethyl methyl ether) (also referred to as 'MEOF' in this specification), first introduced around 1960', was widely used for anaesthesia during the 1960s and early 1970s. It belongs to the fluorinated hydrocarbon group of volatile anaesthetics. Its chemical structure is depicted below:
  • the molecular formula for MEOF is CsH 4 CbF 2 O.
  • Methoxyflurane in clinical practice is (1) its analgesic properties (including at relatively low doses) and (2) its physiological stability, with minimal changes in the cardiovascular system ' even in high doses (up to 3%). ⁇
  • MEOF methoxyflurane
  • nephrotoxicity While the cause of the nephrotoxicity remains the topic of debate, what is clear is that the nephrotoxicity is associated with inorganic fluoride levels, and is dose related. As a result of the nephrotoxicity, from the early 1970s, the use of methoxyflurane in anaesthesia diminished.
  • MEOF as an anaesthetic
  • analgesia extended into the postoperative period, ⁇ v reducing the need for administering analgesia via opioids.
  • Analgesia at sub-anaesthetic doses is a feature of MEOF not shared by other halogenated inhalational anaesthetics/ Therefore, as the anaesthetic use of MEOF declined, it continued to be used in low doses for conscious analgesia.
  • the Analgizer ® device was a very simple device consisting of a cylindrical polyethylene tube, 15 cm long and 2.5 cm in diameter.
  • the sign AnalgizerTM is registered as a trade mark in the United States of America pursuant to United States Trade Mark Registration No 0868724, which at the date of this specification, is owned by Hospira Inc, a Delaware Corporation, of 275 N. Field Drive, Lake Forest, IL 60045, United States of America
  • the device contained a tightly wound, absorbent wick of polypropylene.
  • the PenthroxTM Inhaler has an 'S' shaped wick, is less tightly wound and the intake port at the base is larger to reduce inspiratory resistance and allow a smaller dose to be used (3-6 ml_ vs. 15 mL).
  • the base has been modified to include an inlet nipple, to which an oxygen line can be attached and a one-way valve has been included on the inside of the base to allow inhalation through the wick but prevent exhalations blowing back through the wick into the atmosphere.
  • MEOF is self-administered under observation by patients using the handheld PenthroxTM Inhaler (and the patients are assisted, if necessary). It is indicated for self-administration to patients for the relief of pre-hospital pain, under supervision by personnel trained in its use, and for the relief of pain in short surgical procedures such as the change of dressings, dislocations and greenstick fractures. It is presently used by Australian Ambulance Services, Australian Defense, First-aid Officers, ski-fields and mines and in the Emergency Department of several major Australian hospitals.
  • the current management of incident pain is to administer breakthrough analgesia pre-emptively, using the usual oral breakthrough opioid analgesia for that patient.
  • the problems with this approach include (1) staff time to administer the opioid, with at least two staff members required to cross check the dose, delay in onset of action up to 30 minutes for morphine and oxycodone, two of the commonly used opioid analgesics, (2) the 4 hour half life of these agents, which far exceeds the duration of the painful incident and (3) the side effects experienced, in particular sedation in most and nausea in some patients. Therefore, the post procedure recovery time can be prolonged and necessitates additional time in hospital for outpatient procedures before the patient can safely be discharged home.
  • the invention generally provides a method of treating pain in a patient, the method comprising the step of administering to the patient, an effective dose of Methoxyflurane via an inhaler means.
  • the patient is a mammal.
  • the patient may be a human or non human mammal.
  • the patient is a human subject.
  • the patient could be a non-human mammal.
  • the invention may be used in order to treat either or both: • adult; and
  • the patient is an adult patient.
  • the patient is a human adult subject.
  • the forms of pain experienced by the patient, and which are amenable to treatment by the use of the invention, may arise from any number of causes, including on (or combinations of two or more) of:
  • Pain may be generated in a patient by any number of diseases or pathological conditions.
  • One of the principal disease or pathological conditions which causes pain in patients is cancer.
  • Cancer of cause takes many forms, but in terms of the invention, all forms of cancer induced pain (or forms of pain that are augmented or exacerbated by one or more neoplastic conditions) in a patient are amenable to treatment in accordance with the invention.
  • Particular forms of pain experienced by cancer patients that are amenable to treatment in accordance with the invention include:
  • the invention may also be used to treat pain in patients who sustain an injury or damage. Typical examples here would include the pain suffered by patients who break a bone, or who dislocate a bone or joint.
  • the invention may also be used to treat pain in patients who have undergone an invasive medical procedure.
  • Such procedures include: • Surgical procedures;
  • the physiological nature of the pain experienced by the patient may take one or more of several forms. They include:
  • Nociceptive pain is pain arising from damage to tissues, transmitted to the central nervous system by A ⁇ and C pain fibres. The term may be further explained as follows. "Normally, pain is felt when impulses reach a conscious brain along thinly myelinated (A ⁇ ) and unmyelinated (C) nociceptive afferents. Eg a pinprick or stubbed toe. ...The resulting sensation (pain) matches the stimulus (noxious) "
  • Neuronal pain is pain arising from damage injury and diseases that affect the nervous system directly. The term may be further explained as follows:
  • Neuroopathic pain is thought to result when sensory neurons in the peripheral nervous system generate impulses at abnormal locations, for example at sites of nerve injury.
  • Neuropathic pain often has distinguishing clinical characteristics, which include an unusual quality of the pain (pins and needles, burning, stabbing quality), pain experienced with non-painful stimulation (eg light touch) of an area of skin ("allodynia”), and pain experienced in an area of skin that is numb to touch. Neuropathic pain is generally regarded as being more difficult to relieve successfully.
  • Methoxyflurane is substantially a liquid which may be volatilised, and which has a vapour above the liquid surface. Accordingly, in the method of the invention, the dose of Methoxyflurane is initially in the form of a substantially liquid substance (which is essentially free of other liquids or solvents) in a container which is sealed until use is desired.
  • Methoxyflurane is presented in medical delivery members, such as sealed bottles, vials or jars that contain an amount (normally 3 ml_) of Methoxyflurane in liquid form.
  • the dose could be presented in any suitable form, the nature of which would be apparent to persons of skill in the art.
  • the dose administered to the patient is up to 6 mL per day and no more than 15 mL per week.
  • the dose is up to 3mL of Methoxyflurane, administered over 24 hours.
  • the dose is administered in two stages, namely:
  • the loading dose may be administered over a period of up to 10 minutes.
  • a preferred time for administering the loading dose is a shorter period, such as between one and eight minutes.
  • Methoxyflurane may take place over a longer period, ranging up to 40 minutes or longer.
  • the patient's pain management needs will determine the length of this stage of the administration regime.
  • the Methoxyflurane is administered via an inhaler means.
  • a preferred inhaler means is one which comprises:
  • a body member with a cylindrical wall defining a generally hollow chamber
  • a patient delivery member in fluid communication with the chamber, through which a dose of Methoxyflurane may be delivered to the patient including:
  • a mouthpiece through which the patient can inspire the Methoxyflurane from the chamber and expire gases
  • an inspiratory valve coupled between the mouthpiece and the chamber, the inspiratory valve being configured for opening on inspiration by the patient, and closing upon expiration by the patient
  • An expiratory valve coupled between the mouthpiece and an exhaust external of the chamber, and disposed coaxialiy with the inspiratory valve, the expiratory valve configured for opening upon expiration by the patient, and closing upon inspiration by the patient, and
  • a medication inlet in fluid communication with the chamber, through which medication can be introduced to the chamber, the medication inlet including a dispenser retainer for retaining a medication delivery member on the medication inlet.
  • the use of the method of the invention results in effective pain relief for the patient over a period of time.
  • the use of the method may optionally also be combined with the use of one or more other analgesic agents, including opioid analgesics, paracetamol and other agents, the nature of which would be apparent to those of skill in the art.
  • the use of the method of the invention results in effective pain relief, while avoiding the disadvantages, unwanted effects and/or side effects of the use of traditional opioid analgesia alone.
  • the effective use of the method also optimises the possibility of managing "incident” or "breakthrough" pain associated with inherently painful conditions, such as many neoplastic ailments.
  • Patient demographics were record for the patient group, and these included age, gender, diagnosis, presence of metastases, pain diagnosis, comorbidities, ECOG status, standard analgesia, creatinine, as well as the nature and length of the procedure. The number of breaths taken to load and throughout the procedure was recorded as was concurrent use of oxygen.
  • a nurse attending the patient rated the perceived effectiveness and preference over standard analgesia.
  • a research assistant also rated the performance of the medication using the following parameters: pain control (poor to excellent), side effects, smell and " the perceived acceptability to the patient.
  • VAS range of worst pain score
  • MEOF MEOF over other forms of breakthrough analgesia.
  • the Medical Day Unit staff felt that MEOF had many benefits over the anxiolytic, diazepam, given to patients prior to the bone marrow procedures.
  • Patients also valued the control it gave them over their pain and the distraction of holding the inhaler was also of benefit in minimising the impact of the pain.
  • Table 8 indicates that 36% (95% Cl 19-56%) of patients experienced at least one side effect, with 8 patients (80%) experiencing sedation.
  • One patient discontinued MEOF because of nausea, despite excellent pain relief.
  • MEOF in this clinical setting include its potent analgesic properties, short onset and duration of activity and minimal toxicity. Furthermore, the patient is able to control their own analgesia by using the handheld device whenever they need to during the procedure. This and the resultant minimisation of staff time are important advantages.
  • the uniform dose is also advantageous in comparison to opioid breakthroughs, which require titration for the individual, particularly if they are taking an opioid regularly for pain management.
  • Methoxyflurane analgesia for burns dressings Postgrad Med J 1972;48(557): 128-32.
  • xiii Komesaroff D Serum fluoride ion levels following the administration of methoxyflurane for analgesia. Paper presented at the Australian Society of Anaesthetists Annual General Meeting, Sydney, South Australia, October 1979.
  • xiv Romagnoli A Busque L, Power DJ. The "Analgizer ® " in a general hospital: a preliminary report. Can Anaesth Soc J 1970;17(3):275-8.
  • xv Lewis LA Methoxyflurane analgesia for office surgery. Surgical gem. J Dermatol Surg Oncol 1984;10(2):85-6.

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

Abstract

La présente invention concerne de manière générale un procédé de traitement de la douleur chez un patient. Ce procédé comprend l’étape consistant à administrer au patient une dose efficace de méthoxyflurane au moyen d’un inhalateur. Le patient est de préférence un mammifère. Le patient peut être un mammifère humain ou non humain. Dans un mode de réalisation particulièrement préféré, le patient est un sujet humain. En variante, le patient peut être un mammifère non humain.
PCT/AU2006/001082 2005-07-29 2006-07-31 Procédé de traitement de la douleur chez des patients WO2007033400A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU2006294396A AU2006294396A1 (en) 2005-07-29 2006-07-31 Method of treating pain in patients
EP06827973A EP1922063A4 (fr) 2005-07-29 2006-07-31 Procédé de traitement de la douleur chez des patients

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AU2005904099A AU2005904099A0 (en) 2005-07-29 Method of treating pain in patients
AU2005904099 2005-07-29

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Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009052569A1 (fr) * 2007-10-24 2009-04-30 Colin Dunlop Procédé et médicament pour la gestion de la douleur
WO2010025505A1 (fr) * 2008-09-04 2010-03-11 Phebra Pty Ltd Analgésie par administration transmuqueuse
WO2017011867A1 (fr) 2015-07-20 2017-01-26 Medical Developments International Limited Dispositif d'inhalateur pour liquides à inhaler
WO2017011866A1 (fr) 2015-07-20 2017-01-26 Medical Developments International Limited Dispositif inhalateur pour liquides à inhaler
WO2017011865A1 (fr) 2015-07-20 2017-01-26 Medical Developments International Limited Dispositif d'inhalateur pour liquides à inhaler
RU2659202C1 (ru) * 2017-08-04 2018-06-28 Федеральное государственное бюджетное учреждение науки "Национальный научный центр морской биологии" Дальневосточного отделения Российской академии наук (ННЦМБ ДВО РАН) Средство снижения нейропатической боли
WO2021243407A1 (fr) 2020-06-02 2021-12-09 Medical Developments International Limited Dispositif d'inhalation pour liquides pouvant être inhalés
US11571526B2 (en) 2016-09-06 2023-02-07 Medical Developments International Limited Inhaler device for inhalable liquids

Citations (1)

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Publication number Priority date Publication date Assignee Title
US5227165A (en) * 1989-11-13 1993-07-13 Nova Pharmaceutical Corporation Liposphere delivery systems for local anesthetics

Patent Citations (1)

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Publication number Priority date Publication date Assignee Title
US5227165A (en) * 1989-11-13 1993-07-13 Nova Pharmaceutical Corporation Liposphere delivery systems for local anesthetics

Non-Patent Citations (9)

* Cited by examiner, † Cited by third party
Title
BABL F.E. ET AL.: "Inhaled methoxyflurane as a prehospital analgesic in children", EMERGENCY MEDICINE AUSTRALIA: EMA, vol. 18, no. 4, August 2006 (2006-08-01), pages 404 - 410, XP008079195 *
CLARK R.B. ET AL.: "Effect of methoxyflurane on the fetus", BRITISH JOURNAL OF ANAESTHESIA, vol. 42, no. 4, pages 286 - 294, XP008079198 *
DUNDEE J.W. ET AL.: "Alterations in response to somatic pain associated with anesthesia. XIV. Effects of subnarcotic concentrations of methoxyflurane", BRITISH JOURNAL OF ANAESTHESIA, vol. 35, 1963, pages 301 - 304, XP008079197 *
KOTANI Y. ET AL.: "Effects of noxious stimuli and anesthetic agents on substance P content in rat central nervous system", JAPANESE JOURNAL OF PHARMACOLOGY, vol. 40, no. 1, January 1986 (1986-01-01), pages 143 - 147, XP003009581 *
OYAMA T. ET AL.: "Effect of methoxyflurane analgesia by "analgizer" on pain threshold, blood levels, electroencephalogram, and blood gas", ANESTHESIA AND ANALGESIA, vol. 50, no. 1, January 1971 (1971-01-01) - February 1971 (1971-02-01), pages 43 - 46, XP008079193 *
PARKHOUSE J.: "Inhalation anaesthesia and analgesia", INTERNATIONAL ANESTHESIOLOGY CLINICS, vol. 5, no. 1, 1967, pages 1 - 20, XP008079196 *
ROSEN M.: "Recent advances in pain relief in childbirth. I. Inhalation and systemic analgesia", BRITISH JOURNAL OF ANAESTHESIA, vol. 43, no. 9, September 1971 (1971-09-01), pages 837 - 848, XP008079200 *
See also references of EP1922063A4 *
TOMI K. ET AL.: "Alterations in pain threshold and psychomotor response associated with subanaesthetic concentrations of inhalation anaesthetics in humans", BRITISH JOURNAL OF ANAESTHESIA, vol. 70, no. 6, June 1993 (1993-06-01), pages 684 - 686, XP008079199 *

Cited By (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009052569A1 (fr) * 2007-10-24 2009-04-30 Colin Dunlop Procédé et médicament pour la gestion de la douleur
GB2467266A (en) * 2007-10-24 2010-07-28 Colin Dunlop Method and medicament for pain management
US20110306676A1 (en) * 2007-10-24 2011-12-15 Colin Dunlop Method and Medicament for Pain Management
GB2467266B (en) * 2007-10-24 2012-05-09 Colin Dunlop A Method and medicament for pain management
AU2008316315B2 (en) * 2007-10-24 2015-04-23 Colin Dunlop A method and medicament for pain management
US20170112784A1 (en) * 2007-10-24 2017-04-27 Colin Dunlop Method and Medicament for Pain Management
WO2010025505A1 (fr) * 2008-09-04 2010-03-11 Phebra Pty Ltd Analgésie par administration transmuqueuse
WO2017011865A1 (fr) 2015-07-20 2017-01-26 Medical Developments International Limited Dispositif d'inhalateur pour liquides à inhaler
WO2017011866A1 (fr) 2015-07-20 2017-01-26 Medical Developments International Limited Dispositif inhalateur pour liquides à inhaler
WO2017011867A1 (fr) 2015-07-20 2017-01-26 Medical Developments International Limited Dispositif d'inhalateur pour liquides à inhaler
EP3325062A4 (fr) * 2015-07-20 2019-03-13 Medical Developments International Limited Dispositif inhalateur pour liquides à inhaler
US11672925B2 (en) 2015-07-20 2023-06-13 Medical Developments International Limited Inhaler device for inhalable liquids
US11571526B2 (en) 2016-09-06 2023-02-07 Medical Developments International Limited Inhaler device for inhalable liquids
RU2659202C1 (ru) * 2017-08-04 2018-06-28 Федеральное государственное бюджетное учреждение науки "Национальный научный центр морской биологии" Дальневосточного отделения Российской академии наук (ННЦМБ ДВО РАН) Средство снижения нейропатической боли
WO2021243407A1 (fr) 2020-06-02 2021-12-09 Medical Developments International Limited Dispositif d'inhalation pour liquides pouvant être inhalés
EP4157407A4 (fr) * 2020-06-02 2024-06-05 Medical Developments International Limited Dispositif d'inhalation pour liquides pouvant être inhalés

Also Published As

Publication number Publication date
EP1922063A1 (fr) 2008-05-21
EP1922063A4 (fr) 2009-12-23

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