EP3897579A4 - COMPOSITIONS, DEVICES AND METHODS FOR TREATMENT OF OVERDOSE AND REWARD-BASED DISORDERS - Google Patents

COMPOSITIONS, DEVICES AND METHODS FOR TREATMENT OF OVERDOSE AND REWARD-BASED DISORDERS Download PDF

Info

Publication number: EP3897579A4
Authority: EP; European Patent Office
Prior art keywords: overdose; reward; compositions; treatment; methods
Prior art date: 2018-12-20
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 Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.): Withdrawn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

EP19898164.9A

Other languages

German (de)

French (fr)

Other versions

EP3897579A1 (en

Inventor

Edward T. Maggio

Roger CRYSTAL

Mark ELLISON

Phil Skolnick

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.)

Indivior UK Ltd

Aegis Therapeutics LLC

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.)

2018-12-20

Filing date

2019-12-19

Publication date

2022-11-16

2019-12-19 Application filed by Aegis Therapeutics LLC, Opiant Pharmaceuticals Inc filed Critical Aegis Therapeutics LLC

2021-10-27 Publication of EP3897579A1 publication Critical patent/EP3897579A1/en

2022-11-16 Publication of EP3897579A4 publication Critical patent/EP3897579A4/en

Status Withdrawn legal-status Critical Current

Links

239000000203 mixture Substances 0.000 title 1

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
- 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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/357—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having two or more oxygen atoms in the same ring, e.g. crown ethers, guanadrel
- 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
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4178—1,3-Diazoles not condensed 1,3-diazoles and containing further heterocyclic rings, e.g. pilocarpine, nitrofurantoin
- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- 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
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- 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
- 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
- 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
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
- 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
- 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
- A61M11/007—Syringe-type or piston-type sprayers or atomisers
- 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
- A61M15/0091—Inhalators mechanically breath-triggered
- A61M15/0098—Activated by exhalation
- 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

Landscapes

Health & Medical Sciences (AREA)
Chemical & Material Sciences (AREA)
Life Sciences & Earth Sciences (AREA)
Animal Behavior & Ethology (AREA)
Veterinary Medicine (AREA)
Public Health (AREA)
General Health & Medical Sciences (AREA)
Pharmacology & Pharmacy (AREA)
Medicinal Chemistry (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)
Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
Organic Chemistry (AREA)
Proteomics, Peptides & Aminoacids (AREA)
Neurology (AREA)
Psychiatry (AREA)
Neurosurgery (AREA)
Anesthesiology (AREA)
Heart & Thoracic Surgery (AREA)
Hematology (AREA)
Emergency Medicine (AREA)
Otolaryngology (AREA)
Biochemistry (AREA)
Molecular Biology (AREA)
Inorganic Chemistry (AREA)
Immunology (AREA)
Medicinal Preparation (AREA)
Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

EP19898164.9A 2018-12-20 2019-12-19 COMPOSITIONS, DEVICES AND METHODS FOR TREATMENT OF OVERDOSE AND REWARD-BASED DISORDERS Withdrawn EP3897579A4 (en)

Applications Claiming Priority (3)

Application Number	Priority Date	Filing Date	Title
US201862782943P	2018-12-20	2018-12-20
US201816311944A	2018-12-20	2018-12-20
PCT/US2019/067513 WO2020132263A1 (en)	2018-12-20	2019-12-19	Compositions, devices, and methods for the treatment of overdose and reward-based disorders

Publications (2)

Publication Number	Publication Date
EP3897579A1 EP3897579A1 (en)	2021-10-27
EP3897579A4 true EP3897579A4 (en)	2022-11-16

Family

ID=71100913

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
EP19898164.9A Withdrawn EP3897579A4 (en)	2018-12-20	2019-12-19	COMPOSITIONS, DEVICES AND METHODS FOR TREATMENT OF OVERDOSE AND REWARD-BASED DISORDERS

Country Status (11)

Country	Link
EP (1)	EP3897579A4 (en)
JP (2)	JP2022514340A (en)
KR (1)	KR20210131996A (en)
CN (1)	CN113573696A (en)
AU (1)	AU2019403368A1 (en)
CA (1)	CA3124202A1 (en)
IL (1)	IL284117A (en)
MX (1)	MX2021007522A (en)
PH (1)	PH12021551465A1 (en)
SG (1)	SG11202106531VA (en)
WO (1)	WO2020132263A1 (en)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
WO2018093666A1 (en)	2016-11-18	2018-05-24	Opiant Pharmaceuticals, Inc.	Compositions and methods for the treatment of opioid overdose
CA3227828A1 (en)	2021-08-04	2023-02-09	Indivior Inc.	Compositions and methods for the treatment of opioid overdose

Citations (2)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
WO2017223566A1 (en) *	2016-06-24	2017-12-28	Opiant Pharmaceuticals, Inc.	Compositions, devices, and methods for the treatment of alcohol use disorder
WO2018089709A1 (en) *	2016-11-09	2018-05-17	Opiant Pharmaceuticals, Inc.	Compositions, devices, and methods for the treatment of opioid-receptor-mediated conditions

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
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
JP2010537990A (en) *	2007-08-27	2010-12-09	ユニバーシティオブバージニアパテントファウンデーション	Medicinal combination for the treatment of alcohol addiction and drug addiction
US20140171458A1 (en) *	2012-12-13	2014-06-19	3B Pharmaceuticals, Inc.	Intranasal naltrexone
AU2015228541B2 (en) *	2014-03-14	2020-09-03	Opiant Pharmaceuticals, Inc.	Nasal drug products and methods of their use
JP2019516679A (en) *	2016-05-04	2019-06-20	ウェイブライフサイエンシズリミテッドＷａｖｅＬｉｆｅＳｃｉｅｎｃｅｓＬｔｄ．	Methods and compositions relating to bioactive agents

2019
- 2019-12-19 WO PCT/US2019/067513 patent/WO2020132263A1/en not_active Ceased
- 2019-12-19 JP JP2021535535A patent/JP2022514340A/en active Pending
- 2019-12-19 KR KR1020217022386A patent/KR20210131996A/en not_active Ceased
- 2019-12-19 PH PH1/2021/551465A patent/PH12021551465A1/en unknown
- 2019-12-19 MX MX2021007522A patent/MX2021007522A/en unknown
- 2019-12-19 EP EP19898164.9A patent/EP3897579A4/en not_active Withdrawn
- 2019-12-19 AU AU2019403368A patent/AU2019403368A1/en not_active Abandoned
- 2019-12-19 CN CN201980092189.2A patent/CN113573696A/en active Pending
- 2019-12-19 CA CA3124202A patent/CA3124202A1/en active Pending
- 2019-12-19 SG SG11202106531VA patent/SG11202106531VA/en unknown
2021
- 2021-06-17 IL IL284117A patent/IL284117A/en unknown
2024
- 2024-08-23 JP JP2024141729A patent/JP2024164155A/en active Pending

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
WO2017223566A1 (en) *	2016-06-24	2017-12-28	Opiant Pharmaceuticals, Inc.	Compositions, devices, and methods for the treatment of alcohol use disorder
WO2018089709A1 (en) *	2016-11-09	2018-05-17	Opiant Pharmaceuticals, Inc.	Compositions, devices, and methods for the treatment of opioid-receptor-mediated conditions

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO2020132263A1 *

Also Published As

Publication number	Publication date
KR20210131996A (en)	2021-11-03
JP2024164155A (en)	2024-11-26
SG11202106531VA (en)	2021-07-29
JP2022514340A (en)	2022-02-10
MX2021007522A (en)	2021-08-05
CA3124202A1 (en)	2020-06-25
IL284117A (en)	2021-08-31
PH12021551465A1 (en)	2022-04-11
CN113573696A (en)	2021-10-29
EP3897579A1 (en)	2021-10-27
WO2020132263A1 (en)	2020-06-25
AU2019403368A1 (en)	2021-07-29

Legal Events

Date	Code	Title	Description
2020-07-02	STAA	Information on the status of an ep patent application or granted ep patent	Free format text: STATUS: THE INTERNATIONAL PUBLICATION HAS BEEN MADE
2021-09-24	PUAI	Public reference made under article 153(3) epc to a published international application that has entered the european phase	Free format text: ORIGINAL CODE: 0009012
2021-09-24	STAA	Information on the status of an ep patent application or granted ep patent	Free format text: STATUS: REQUEST FOR EXAMINATION WAS MADE
2021-10-27	17P	Request for examination filed	Effective date: 20210624
2021-10-27	AK	Designated contracting states	Kind code of ref document: A1 Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR
2022-03-11	REG	Reference to a national code	Ref country code: HK Ref legal event code: DE Ref document number: 40055520 Country of ref document: HK
2022-03-30	DAV	Request for validation of the european patent (deleted)
2022-03-30	DAX	Request for extension of the european patent (deleted)
2022-11-16	A4	Supplementary search report drawn up and despatched	Effective date: 20221017
2022-11-16	RIC1	Information provided on ipc code assigned before grant	Ipc: A61M 11/00 20060101ALI20221011BHEP Ipc: A61M 15/00 20060101ALI20221011BHEP Ipc: A61K 38/00 20060101ALI20221011BHEP Ipc: A61K 31/485 20060101ALI20221011BHEP Ipc: A61K 31/496 20060101ALI20221011BHEP Ipc: A61K 31/4178 20060101ALI20221011BHEP Ipc: A61K 31/357 20060101ALI20221011BHEP Ipc: A61P 1/00 20060101ALI20221011BHEP Ipc: A61K 9/20 20060101ALI20221011BHEP Ipc: A61K 47/26 20060101ALI20221011BHEP Ipc: A61K 47/18 20170101ALI20221011BHEP Ipc: A61K 9/00 20060101AFI20221011BHEP
2024-06-05	RAP1	Party data changed (applicant data changed or rights of an application transferred)	Owner name: INDIVIOR UK LIMITED Owner name: AEGIS THERAPEUTICS, LLC
2025-03-21	STAA	Information on the status of an ep patent application or granted ep patent	Free format text: STATUS: THE APPLICATION HAS BEEN WITHDRAWN
2025-04-23	18W	Application withdrawn	Effective date: 20250318

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