AU2017281941A1 - Compositions, devices, and methods for the treatment of alcohol use disorder - Google Patents

Compositions, devices, and methods for the treatment of alcohol use disorder Download PDF

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Publication number
AU2017281941A1
AU2017281941A1 AU2017281941A AU2017281941A AU2017281941A1 AU 2017281941 A1 AU2017281941 A1 AU 2017281941A1 AU 2017281941 A AU2017281941 A AU 2017281941A AU 2017281941 A AU2017281941 A AU 2017281941A AU 2017281941 A1 AU2017281941 A1 AU 2017281941A1
Authority
AU
Australia
Prior art keywords
recited
naltrexone
formulation
dose
intranasal
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.)
Abandoned
Application number
AU2017281941A
Other languages
English (en)
Inventor
Arvind Agrawal
Roger CRYSTAL
Edward T. Maggio
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.)
Aegis Therapeutics LLC
Opiant Pharmaceuticals Inc
Original Assignee
Aegis Therapeutics LLC
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 Aegis Therapeutics LLC, Opiant Pharmaceuticals Inc filed Critical Aegis Therapeutics LLC
Publication of AU2017281941A1 publication Critical patent/AU2017281941A1/en
Priority to AU2023202420A priority Critical patent/AU2023202420A1/en
Abandoned legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • 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
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0065—Inhalators with dosage or measuring devices
    • A61M15/0068—Indicating or counting the number of dispensed doses or of remaining doses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/08—Inhaling devices inserted into the nose
    • 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
    • A61P25/32—Alcohol-abuse
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/006—Sprayers or atomisers specially adapted for therapeutic purposes operated by applying mechanical pressure to the liquid to be sprayed or atomised
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/06—Inhaling appliances shaped like cigars, cigarettes or pipes

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Addiction (AREA)
  • Biomedical Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Otolaryngology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Psychiatry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Emergency Medicine (AREA)
  • Pulmonology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Biophysics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Mechanical Engineering (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
AU2017281941A 2016-06-24 2017-06-26 Compositions, devices, and methods for the treatment of alcohol use disorder Abandoned AU2017281941A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2023202420A AU2023202420A1 (en) 2016-06-24 2023-04-20 Compositions, devices, and methods for the treatment of alcohol use disorder

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201662354465P 2016-06-24 2016-06-24
US62/354,465 2016-06-24
US201662419736P 2016-11-09 2016-11-09
US62/419,736 2016-11-09
PCT/US2017/039300 WO2017223566A1 (en) 2016-06-24 2017-06-26 Compositions, devices, and methods for the treatment of alcohol use disorder

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2023202420A Division AU2023202420A1 (en) 2016-06-24 2023-04-20 Compositions, devices, and methods for the treatment of alcohol use disorder

Publications (1)

Publication Number Publication Date
AU2017281941A1 true AU2017281941A1 (en) 2019-02-07

Family

ID=60784803

Family Applications (2)

Application Number Title Priority Date Filing Date
AU2017281941A Abandoned AU2017281941A1 (en) 2016-06-24 2017-06-26 Compositions, devices, and methods for the treatment of alcohol use disorder
AU2023202420A Abandoned AU2023202420A1 (en) 2016-06-24 2023-04-20 Compositions, devices, and methods for the treatment of alcohol use disorder

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2023202420A Abandoned AU2023202420A1 (en) 2016-06-24 2023-04-20 Compositions, devices, and methods for the treatment of alcohol use disorder

Country Status (13)

Country Link
US (1) US20190209464A1 (https=)
EP (1) EP3474842A4 (https=)
JP (2) JP2019520361A (https=)
KR (2) KR102634829B1 (https=)
CN (1) CN109789122A (https=)
AU (2) AU2017281941A1 (https=)
CA (1) CA3028731A1 (https=)
MX (2) MX2018015985A (https=)
NZ (1) NZ750067A (https=)
PH (1) PH12018502738A1 (https=)
RU (2) RU2767062C2 (https=)
SG (2) SG11201811580SA (https=)
WO (1) WO2017223566A1 (https=)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR102634829B1 (ko) * 2016-06-24 2024-02-07 오피언트 파마슈티컬스, 인코퍼레이티드 알코올 사용 장애의 치료용 조성물, 장치 및 방법
US11069446B1 (en) * 2016-09-28 2021-07-20 Cerner Innovation, Inc. Predicting addiction relapse and decision support tool
CA3043028A1 (en) * 2016-11-09 2018-05-17 Opiant Pharmaceuticals, Inc. Compositions, devices, and methods for the treatment of opioid-receptor-mediated conditions
IL312012A (en) * 2016-11-18 2024-06-01 Opiant Pharmaceuticals Inc Compositions and methods for the treatment of opioid overdose
WO2019157099A1 (en) 2018-02-06 2019-08-15 Aegis Therapeutics, Llc Intranasal epinephrine formulations and methods for the treatment of disease
WO2019222408A1 (en) * 2018-05-17 2019-11-21 Aegis Therapeutics Llc Formulations and methods for the prevention of opioid overdose
AU2019403368A1 (en) * 2018-12-20 2021-07-29 Aegis Therapeutics, Llc Compositions, devices, and methods for the treatment of overdose and reward-based disorders
AU2020245535B2 (en) 2019-03-26 2022-06-30 Pinova Therapeutics Inc. Devices and methods for delivering pharmaceutical compositions
CN113784703A (zh) * 2019-05-16 2021-12-10 株式会社新日本科学 经鼻施予用粉末制剂及其制造方法
US10729687B1 (en) 2019-07-09 2020-08-04 Orexo Ab Pharmaceutical composition for nasal delivery
US10653690B1 (en) * 2019-07-09 2020-05-19 Orexo Ab Pharmaceutical composition for nasal delivery
CA3166250A1 (en) 2020-02-05 2021-08-12 Gregory G. Plucinski Drug products for intranasal administration and uses thereof
US11278709B1 (en) 2021-03-12 2022-03-22 Pocket Naloxone Corp. Drug delivery device and methods for using same
MX2024001659A (es) 2021-08-04 2024-06-26 Indivior Inc Composiciones y métodos para el tratamiento de la sobredosis por opioides.
US20250134883A1 (en) * 2022-01-26 2025-05-01 Tulex Pharmaceuticals Inc. Novel compositions

Family Cites Families (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4882335A (en) * 1988-06-13 1989-11-21 Alko Limited Method for treating alcohol-drinking response
US5069895A (en) * 1989-11-09 1991-12-03 Diamond Ivan F Methods for the treatment of alcohol intoxication and dependence
EP0444778A1 (en) * 1990-02-14 1991-09-04 Alcon Laboratories, Inc. Use of alkyl saccharides to enhance the penetration of drugs
EP1423116A1 (en) * 2001-08-14 2004-06-02 Biotie Therapies Corp. Method of treating alcoholism or alcohol abuse
US9895444B2 (en) * 2004-08-25 2018-02-20 Aegis Therapeutics, Llc Compositions for drug administration
US8268791B2 (en) * 2004-08-25 2012-09-18 Aegis Therapeutics, Llc. Alkylglycoside compositions for drug administration
US20070212307A1 (en) * 2006-02-10 2007-09-13 Daniel Wermeling Pharmaceutical Compositions Comprising an Opioid Receptor Antagonist and Methods of Using Same
US20100076006A1 (en) * 2007-01-31 2010-03-25 University Of Virginia Patent Foundation Topiramate Plus Naltrexone for the Treatment of Addictive Disorders
WO2009029308A1 (en) * 2007-08-27 2009-03-05 University Of Virginia Patent Foundation Medication combinations for the treatment of alcoholism and drug addiction
JP5437236B2 (ja) * 2008-04-16 2014-03-12 一般財団法人化学及血清療法研究所 トロンビン固定化生体吸収性シート製剤の製造方法
PE20131137A1 (es) * 2010-10-29 2013-10-03 Troikaa Pharmaceuticals Ltd Composiciones nasales de vitamina b12
MY194947A (en) * 2011-05-13 2022-12-27 Euro Celtique Sa Intranasal pharmaceutical dosage forms comprising naloxone
US10485798B2 (en) * 2012-08-22 2019-11-26 Aptapharma Inc. Methylnaltrexone nasal formulations, methods of making, and use thereof
US20140171458A1 (en) * 2012-12-13 2014-06-19 3B Pharmaceuticals, Inc. Intranasal naltrexone
DE202013105715U1 (de) * 2013-08-22 2014-02-19 Sipnose Ltd. Vorrichtung zur Abgabe einer vorbestimmten Menge einer Substanz an eine natürliche Öffnung des Körpers
WO2015095389A1 (en) * 2013-12-18 2015-06-25 Aegis Therapeutics, Llc Compositions for drug administration
US9480644B2 (en) * 2014-03-14 2016-11-01 Opiant Pharmaceuticals, Inc. Nasal drug products and methods of their use
KR102634829B1 (ko) * 2016-06-24 2024-02-07 오피언트 파마슈티컬스, 인코퍼레이티드 알코올 사용 장애의 치료용 조성물, 장치 및 방법

Also Published As

Publication number Publication date
EP3474842A4 (en) 2020-01-29
KR102634829B1 (ko) 2024-02-07
JP2019520361A (ja) 2019-07-18
NZ750067A (en) 2025-11-28
CA3028731A1 (en) 2017-12-28
MX2022013671A (es) 2022-12-13
AU2023202420A1 (en) 2023-05-11
RU2019101810A3 (https=) 2020-10-14
KR20190055057A (ko) 2019-05-22
RU2022103366A (ru) 2022-03-01
RU2767062C2 (ru) 2022-03-16
MX2018015985A (es) 2019-09-13
SG11201811580SA (en) 2019-01-30
EP3474842A1 (en) 2019-05-01
PH12018502738A1 (en) 2019-10-21
RU2019101810A (ru) 2020-07-27
CN109789122A (zh) 2019-05-21
US20190209464A1 (en) 2019-07-11
KR20220167279A (ko) 2022-12-20
WO2017223566A1 (en) 2017-12-28
JP7492548B2 (ja) 2024-05-29
SG10202013034QA (en) 2021-02-25
KR102453781B1 (ko) 2022-10-12
JP2022088592A (ja) 2022-06-14

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Legal Events

Date Code Title Description
DA3 Amendments made section 104

Free format text: THE NATURE OF THE AMENDMENT IS: AMEND THE NAME OF THE INVENTOR TO READ CRYSTAL, ROGER; AGRAWAL, ARVIND AND MAGGIO, EDWARD T.

MK5 Application lapsed section 142(2)(e) - patent request and compl. specification not accepted