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WO2016193456A3 - Opioid receptor antagonist for use in treating patients with severe constipation - Google Patents

Opioid receptor antagonist for use in treating patients with severe constipation Download PDF

Info

Publication number
WO2016193456A3
WO2016193456A3 PCT/EP2016/062692 EP2016062692W WO2016193456A3 WO 2016193456 A3 WO2016193456 A3 WO 2016193456A3 EP 2016062692 W EP2016062692 W EP 2016062692W WO 2016193456 A3 WO2016193456 A3 WO 2016193456A3
Authority
WO
WIPO (PCT)
Prior art keywords
receptor antagonist
opioid receptor
treating patients
opioid
severe constipation
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/EP2016/062692
Other languages
French (fr)
Other versions
WO2016193456A2 (en
Inventor
Hélène Rey
Olaf MUNDSZINGER
Isabelle GOLFIER
Silvia JAKOB
Oliver RUSCH
Marc Fischer
Christian Holl
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Develco Pharma Schweiz AG
Original Assignee
Develco Pharma Schweiz AG
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 Develco Pharma Schweiz AG filed Critical Develco Pharma Schweiz AG
Priority to EP16730722.2A priority Critical patent/EP3302476A2/en
Publication of WO2016193456A2 publication Critical patent/WO2016193456A2/en
Publication of WO2016193456A3 publication Critical patent/WO2016193456A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/10—Laxatives

Landscapes

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

Abstract

The present invention relates to a pharmaceutical composition comprising an opioid receptor antagonist, or a derivative or a pharmaceutically acceptable salt thereof, as an active substance, wherein the composition releases the active substance in a prolonged manner. The composition that is suitable for an administration period of at least twelve-hours for the treatment of severe opioid- induced constipation in patients receiving a daily dosage of opioid equivalent to at least 80 mg of morphine.
PCT/EP2016/062692 2015-06-03 2016-06-03 Opioid receptor antagonist for use in treating patients with severe constipation Ceased WO2016193456A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP16730722.2A EP3302476A2 (en) 2015-06-03 2016-06-03 Opioid receptor antagonist for use in treating patients with severe constipation

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
EPEP15170570.4 2015-06-03
EP15170570 2015-06-03
EPEP15170566.2 2015-06-03
EP15170566 2015-06-03

Publications (2)

Publication Number Publication Date
WO2016193456A2 WO2016193456A2 (en) 2016-12-08
WO2016193456A3 true WO2016193456A3 (en) 2017-01-12

Family

ID=56148357

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2016/062692 Ceased WO2016193456A2 (en) 2015-06-03 2016-06-03 Opioid receptor antagonist for use in treating patients with severe constipation

Country Status (1)

Country Link
WO (1) WO2016193456A2 (en)

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001032180A2 (en) * 1999-11-01 2001-05-10 Rodeva Limited Composition for treatment of constipation and irritable bowel syndrome
WO2004091622A1 (en) * 2003-04-08 2004-10-28 Progenics Pharmaceuticals, Inc. The use of peripheral opiois antagonists, especially methylnaltrexone to treat irritable bowel syndrome
WO2004091665A1 (en) * 2003-04-08 2004-10-28 Progenics Pharmaceuticals, Inc. Combination therapy for constipation comprising a laxative and a peripheral opioid antagonist
WO2005107726A2 (en) * 2004-04-27 2005-11-17 Pain Therapeutics, Inc. Method for the treatment of back pain
EP1695700A1 (en) * 2005-02-28 2006-08-30 Euro-Celtique S.A. Dosage form containing oxycodone and naloxone
WO2006127899A2 (en) * 2005-05-25 2006-11-30 Progenics Pharmaceuticals, Inc. (r)-n-methylnaltrexone, processes for its synthesis and its pharmaceutical use
US20100221339A1 (en) * 2006-01-19 2010-09-02 Phoenux Ag Use of a combination of morphine and at least one opiate antagonist to treat opiate dependency and prevent non-oral opiate abuse among opiate addicts
WO2015071380A1 (en) * 2013-11-13 2015-05-21 Euro-Celtique S.A. Hydromorphone and naloxone for treatment of pain and opioid bowel dysfunction syndrome

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19651551C2 (en) 1996-12-11 2000-02-03 Klinge Co Chem Pharm Fab Opioid antagonist-containing galenic formulation
IT1398930B1 (en) 2010-03-24 2013-03-28 Molteni & C PHARMACEUTICAL FORMULATIONS BISTRATO CONTAINING OPPOSING AGONISTS AND ANTAGONISTS.

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001032180A2 (en) * 1999-11-01 2001-05-10 Rodeva Limited Composition for treatment of constipation and irritable bowel syndrome
WO2004091622A1 (en) * 2003-04-08 2004-10-28 Progenics Pharmaceuticals, Inc. The use of peripheral opiois antagonists, especially methylnaltrexone to treat irritable bowel syndrome
WO2004091665A1 (en) * 2003-04-08 2004-10-28 Progenics Pharmaceuticals, Inc. Combination therapy for constipation comprising a laxative and a peripheral opioid antagonist
WO2005107726A2 (en) * 2004-04-27 2005-11-17 Pain Therapeutics, Inc. Method for the treatment of back pain
EP1695700A1 (en) * 2005-02-28 2006-08-30 Euro-Celtique S.A. Dosage form containing oxycodone and naloxone
WO2006127899A2 (en) * 2005-05-25 2006-11-30 Progenics Pharmaceuticals, Inc. (r)-n-methylnaltrexone, processes for its synthesis and its pharmaceutical use
US20100221339A1 (en) * 2006-01-19 2010-09-02 Phoenux Ag Use of a combination of morphine and at least one opiate antagonist to treat opiate dependency and prevent non-oral opiate abuse among opiate addicts
WO2015071380A1 (en) * 2013-11-13 2015-05-21 Euro-Celtique S.A. Hydromorphone and naloxone for treatment of pain and opioid bowel dysfunction syndrome

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
JURNA I ET AL: "Retardiert freigesetztes Naloxon oral: Aufhebung der Obstipation durch orales Morphin ohne Beseitigung der Analgesie. [Oral administration of slow-release naloxone for prevention of constipation but not analgesia following oral morphine.]", SCHMERZ, DER, SPRINGER VERLAG, BERLIN, DE, vol. 7, no. 4, 1 December 1993 (1993-12-01), pages 314 - 321, XP009176556, ISSN: 0932-433X *

Also Published As

Publication number Publication date
WO2016193456A2 (en) 2016-12-08

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