EP3349756A4 - Nasal drug products and methods of their use - Google Patents

Nasal drug products and methods of their use Download PDF

Info

Publication number
EP3349756A4
EP3349756A4 EP16847459.1A EP16847459A EP3349756A4 EP 3349756 A4 EP3349756 A4 EP 3349756A4 EP 16847459 A EP16847459 A EP 16847459A EP 3349756 A4 EP3349756 A4 EP 3349756A4
Authority
EP
European Patent Office
Prior art keywords
methods
drug products
nasal drug
nasal
products
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.)
Withdrawn
Application number
EP16847459.1A
Other languages
German (de)
French (fr)
Other versions
EP3349756A1 (en
Inventor
Fintan Keegan
Robert Gerard Bell
Roger CRYSTAL
Michael Brenner Weiss
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.)
Emergent Biosolutions Ireland Ltd
Opiant Pharmaceuticals Inc
Original Assignee
Adapt Pharma Ltd
Opiant Pharmaceuticals Inc
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 Adapt Pharma Ltd, Opiant Pharmaceuticals Inc filed Critical Adapt Pharma Ltd
Publication of EP3349756A1 publication Critical patent/EP3349756A1/en
Publication of EP3349756A4 publication Critical patent/EP3349756A4/en
Withdrawn legal-status Critical Current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
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/186—Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
    • 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
    • A61K9/08—Solutions
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/12—Aerosols; Foams
    • 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
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/36—Opioid-abuse
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0043—Nose

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Dispersion Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Addiction (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Psychiatry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Emergency Medicine (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
EP16847459.1A 2015-09-17 2016-09-16 Nasal drug products and methods of their use Withdrawn EP3349756A4 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201562219955P 2015-09-17 2015-09-17
US201662274536P 2016-01-04 2016-01-04
PCT/US2016/052280 WO2017049181A1 (en) 2015-09-17 2016-09-16 Nasal drug products and methods of their use

Publications (2)

Publication Number Publication Date
EP3349756A1 EP3349756A1 (en) 2018-07-25
EP3349756A4 true EP3349756A4 (en) 2019-05-15

Family

ID=58289745

Family Applications (1)

Application Number Title Priority Date Filing Date
EP16847459.1A Withdrawn EP3349756A4 (en) 2015-09-17 2016-09-16 Nasal drug products and methods of their use

Country Status (4)

Country Link
EP (1) EP3349756A4 (en)
CA (1) CA2950687C (en)
MX (1) MX2018003349A (en)
WO (1) WO2017049181A1 (en)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20180193332A1 (en) * 2017-10-09 2018-07-12 Adapt Pharma Operations Limited Low-temperature stable opioid antagonist solutions

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004054511A2 (en) * 2002-12-13 2004-07-01 The Regents Of The University Of California Analgesic combination comprising nalbuphine
CN1575795A (en) * 2003-06-25 2005-02-09 中国人民解放军军事医学科学院毒物药物研究所 Naloxone hydrochloride nasal spray
WO2012156317A2 (en) * 2011-05-13 2012-11-22 Euro-Celtique S.A. Intranasal pharmaceutical dosage forms comprising naloxone
US20150174061A1 (en) * 2013-12-20 2015-06-25 AntiOP, Inc. Intranasal naloxone compositions and methods of making and using same

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SG10202003562WA (en) * 2014-03-14 2020-05-28 Opiant Pharmaceuticals Inc Nasal drug products and methods of their use

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004054511A2 (en) * 2002-12-13 2004-07-01 The Regents Of The University Of California Analgesic combination comprising nalbuphine
CN1575795A (en) * 2003-06-25 2005-02-09 中国人民解放军军事医学科学院毒物药物研究所 Naloxone hydrochloride nasal spray
WO2012156317A2 (en) * 2011-05-13 2012-11-22 Euro-Celtique S.A. Intranasal pharmaceutical dosage forms comprising naloxone
US20150174061A1 (en) * 2013-12-20 2015-06-25 AntiOP, Inc. Intranasal naloxone compositions and methods of making and using same

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
BARTON E D ET AL: "Efficacy of intranasal naloxone as a needleless alternative for treatment of opioid overdose in the prehospital setting", JOURNAL OF EMERGENCY MEDICINE, PERGAMON PRESS, NEW YORK, NY, GB, vol. 29, no. 3, 1 October 2005 (2005-10-01), pages 265 - 271, XP027720685, ISSN: 0736-4679, [retrieved on 20051001] *
CHANGNING GUO ET AL: "The Influence of Actuation Parameters on in Vitro Testing of Nasal Spray Products", JOURNAL OF PHARMACEUTICAL SCIENCES, vol. 95, no. 9, 9 September 2006 (2006-09-09), US, pages 2029 - 2040, XP055519728, ISSN: 0022-3549, DOI: 10.1002/jps.20678 *
DANIEL P. WERMELING: "A response to the opioid overdose epidemic: naloxone nasal spray", DRUG DELIVERY AND TRANSLATIONAL RESEARCH, vol. 3, no. 1, 1 August 2012 (2012-08-01), Germany, pages 63 - 74, XP055501576, ISSN: 2190-393X, DOI: 10.1007/s13346-012-0092-0 *
See also references of WO2017049181A1 *

Also Published As

Publication number Publication date
EP3349756A1 (en) 2018-07-25
MX2018003349A (en) 2018-11-12
WO2017049181A1 (en) 2017-03-23
CA2950687C (en) 2023-02-28
CA2950687A1 (en) 2017-03-17

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Ipc: A61K 31/485 20060101AFI20190409BHEP

Ipc: A61K 31/4468 20060101ALI20190409BHEP

Ipc: A61K 31/451 20060101ALI20190409BHEP

RIN1 Information on inventor provided before grant (corrected)

Inventor name: CRYSTAL, ROGER

Inventor name: BELL, ROBERT GERARD

Inventor name: KEEGAN, FINTAN

Inventor name: WEISS, MICHAEL BRENNER

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