JP2023507926A - 神経精神状態または神経学的状態を治療するためのエスケタミンを用いた投与計画 - Google Patents

神経精神状態または神経学的状態を治療するためのエスケタミンを用いた投与計画 Download PDF

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JP2023507926A
JP2023507926A JP2022534833A JP2022534833A JP2023507926A JP 2023507926 A JP2023507926 A JP 2023507926A JP 2022534833 A JP2022534833 A JP 2022534833A JP 2022534833 A JP2022534833 A JP 2022534833A JP 2023507926 A JP2023507926 A JP 2023507926A
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esketamine
disorder
administration
treatment
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JP2023507926A5 (https=
JPWO2021137148A5 (https=
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ゲルション、アリ
ダンゴール、デビッド
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クレキシオ バイオサイエンシーズ エルティーディー.
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Priority claimed from PCT/IB2020/062508 external-priority patent/WO2021137148A1/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/138Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/15Oximes (>C=N—O—); Hydrazines (>N—N<); Hydrazones (>N—N=) ; Imines (C—N=C)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/34Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
    • A61K31/343Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/38Heterocyclic compounds having sulfur as a ring hetero atom
    • A61K31/381Heterocyclic compounds having sulfur as a ring hetero atom having five-membered rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445Non condensed piperidines, e.g. piperocaine
    • A61K31/4523Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/4525Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a five-membered ring with oxygen as a ring hetero atom
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/02Drugs for disorders of the nervous system for peripheral neuropathies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/18Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/22Anxiolytics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/24Antidepressants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/28Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Psychiatry (AREA)
  • Pain & Pain Management (AREA)
  • Emergency Medicine (AREA)
  • Hospice & Palliative Care (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2022534833A 2019-12-30 2020-12-29 神経精神状態または神経学的状態を治療するためのエスケタミンを用いた投与計画 Pending JP2023507926A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962954790P 2019-12-30 2019-12-30
US62/954,790 2019-12-30
PCT/IB2020/062508 WO2021137148A1 (en) 2019-12-30 2020-12-29 Dosage regime with esketamine for treating neuropsychiatric or neurological conditions

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JP2023507926A true JP2023507926A (ja) 2023-02-28
JP2023507926A5 JP2023507926A5 (https=) 2024-01-09
JPWO2021137148A5 JPWO2021137148A5 (https=) 2024-01-09

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Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SI3043785T1 (sl) 2013-09-13 2022-02-28 National University Corporation Chiba University Uporaba R-ketamina in njegove soli kot farmacevtska sredstva
PL3505157T3 (pl) 2017-12-29 2022-04-11 Celon Pharma S.A. Kompozycja ketaminy w postaci suchego proszku do podawania dopłucnego w leczeniu depresji opornej na leczenie
JP7548669B2 (ja) 2018-02-15 2024-09-10 国立大学法人千葉大学 炎症性疾患若しくは骨疾患の予防又は治療剤及び医薬組成物
AU2019262197B2 (en) 2018-05-04 2024-12-19 Perception Neuroscience, Inc. Methods of treating substance abuse

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120225949A1 (en) * 2009-08-14 2012-09-06 Demitri Papalos Compositions and methods for treating bipolar disorder
WO2019073408A1 (en) * 2017-10-10 2019-04-18 Douglas Pharmaceuticals Ltd. PROLONGED RELEASE PHARMACEUTICAL FORMULATION AND TREATMENT METHODS

Family Cites Families (36)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CH535201A (de) 1969-12-19 1973-03-31 Bristol Myers Co Verfahren zur Spaltung von racemischen 2-(o-Chlorphenyl)-2-methylaminocyclohexanon in die optisch-aktiven Isomeren
JP4694207B2 (ja) 2002-07-05 2011-06-08 コルジウム ファーマシューティカル, インコーポレイテッド オピオイドおよび他の薬物に関する乱用抑止性の薬学的組成物
WO2007111880A2 (en) 2006-03-22 2007-10-04 Mount Sinai School Of Medicine Intranasal administration of ketamine to treat depression
US20080069891A1 (en) 2006-09-15 2008-03-20 Cima Labs, Inc. Abuse resistant drug formulation
SA07280459B1 (ar) 2006-08-25 2011-07-20 بيورديو فارما إل. بي. أشكال جرعة صيدلانية للتناول عن طريق الفم مقاومة للعبث تشتمل على مسكن شبه أفيوني
DE102007009888A1 (de) 2007-02-28 2008-09-04 Hermann, Holger Lars, Dr. Verwendung von S-(+)-Ketamin zur Behandlung von Depressionen
AU2008286914B2 (en) 2007-08-13 2014-10-02 Ohemo Life Sciences Inc. Abuse resistant drugs, method of use and method of making
NZ589764A (en) 2008-05-09 2012-10-26 Univ Emory NMDA receptor antagonists for the treatment of neuropsychiatric disorders
US20110038807A1 (en) 2009-08-14 2011-02-17 Demitri Papolos Compositions and methods for treating bipolar disorder
US9737531B2 (en) 2012-07-12 2017-08-22 Glytech, Llc Composition and method for treatment of depression and psychosis in humans
PE20141906A1 (es) 2012-03-12 2014-12-05 Janssen Pharmaceutica Nv Esketamina para el tratamiento de la depresion refractaria al tratamiento o resistente al tratamiento
AU2013285988A1 (en) 2012-07-06 2015-02-12 Egalet Ltd. Abuse deterrent pharmaceutical compositions for controlled release
WO2014020155A1 (en) 2012-08-02 2014-02-06 Clinpharm Reform Gmbh Oral transmucosal adminstration forms of s-ketamine
US9468611B2 (en) 2012-09-27 2016-10-18 Relmada Therapeutics, Inc. d-Methadone for the treatment of psychiatric symptoms
WO2014117089A1 (en) 2013-01-25 2014-07-31 Case Western Reserve University Compositions and methods for the treatment of pervasive development disorders
JP6462663B2 (ja) 2013-04-12 2019-01-30 アイカーン スクール オブ メディシン アット マウント シナイ 心的外傷後ストレス障害を処置するための方法
US9913803B2 (en) 2013-08-26 2018-03-13 Amorsa Therapeutics, Inc. Single-layer oral dose of neuro-attenuating ketamine
WO2015051259A1 (en) 2013-10-04 2015-04-09 Impax Laboratories, Inc. Pharmaceutical compositions and methods of use
EA032013B1 (ru) 2013-10-31 2019-03-29 Сайма Лэбс Инк. Препятствующие злоупотреблению гранулированные лекарственные формы с немедленным высвобождением
DK3272338T3 (da) 2014-04-17 2020-11-02 Develco Pharma Schweiz Ag Oral doseringsform for ketamin
CN107208133A (zh) 2014-09-15 2017-09-26 詹森药业有限公司 用于治疗抑郁症的Val66Met (SNPrs6265)基因型特异性给药方案和方法
AU2015343083B2 (en) 2014-11-04 2020-07-23 Acadia Pharmaceuticals Inc. Neuro-attenuating ketamine and norketamine compounds, derivatives thereof, and methods
JP6696994B2 (ja) 2014-12-08 2020-05-20 クレシオ・バイオサイエンシズ・リミテッド 即放性乱用抑止性顆粒剤形
US20160332962A1 (en) 2015-05-13 2016-11-17 Janssen Pharmaceutica Nv (s)-csa salt of s-ketamine, (r)-csa salt of s-ketamine and processes for the preparation of s-ketamine
US20160338977A1 (en) 2015-05-20 2016-11-24 Janssen Pharmaceutica Nv Methods and kits for treating depression
WO2017041112A1 (en) 2015-09-04 2017-03-09 Cyprus Therapeutics, Inc. Ketamine and cytochrome p 450 inhibitor combinations
EP3377050A4 (en) 2015-11-17 2019-11-20 The Trustees of Columbia University in the City of New York PHARMACOLOGICAL PROPHYLACTICS AGAINST STRESS-INDUCED AFFECTIVE DISORDERS AND THEIR ASSOCIATED SYMPTOMS
US20190240184A1 (en) 2016-10-27 2019-08-08 National University Corporation Chiba University Pharmaceutical applications for (s)-norketamine and salts thereof
ES2991544T3 (es) 2016-11-30 2024-12-04 Wolfson Philip E Ketamina para el tratamiento de síntomas relacionados con la menstruación
EP3641742B1 (en) 2017-06-23 2026-03-25 Ketabon GmbH Hydroxynorketamine for the use in the treatment of depression
MX2020006650A (es) 2017-12-22 2020-11-06 Janssen Pharmaceuticals Inc Esketamina para el tratamiento de la depresión.
JP2021529732A (ja) 2018-06-27 2021-11-04 クレキシオ バイオサイエンシーズ エルティーディー. 大うつ病性障害の処置方法
KR20210074275A (ko) 2018-10-05 2021-06-21 클렉시오 바이오사이언시스 리미티드 주요 우울 장애를 치료하기 위한 에스케타민의 복용 요법
EP3923920A4 (en) 2019-08-05 2022-11-23 The Ketamine Research Foundation KETAMINE FOR THE TREATMENT OF SYMPTOMS AND DISORDERS AFTER CHILDREN
TW202135787A (zh) 2019-12-12 2021-10-01 比利時商健生藥品公司 艾氯胺酮調配物及製備與儲存的方法
WO2021137147A1 (en) 2019-12-30 2021-07-08 Clexio Biosciences Ltd. Dosage regime with esketamine for treating major depressive disorder

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120225949A1 (en) * 2009-08-14 2012-09-06 Demitri Papalos Compositions and methods for treating bipolar disorder
WO2019073408A1 (en) * 2017-10-10 2019-04-18 Douglas Pharmaceuticals Ltd. PROLONGED RELEASE PHARMACEUTICAL FORMULATION AND TREATMENT METHODS

Non-Patent Citations (5)

* Cited by examiner, † Cited by third party
Title
ACTA NEUROPSYCHIATRICA, vol. 31(5):258-265, JPN6025005379, October 2019 (2019-10-01), ISSN: 0005529926 *
BMC PSYCHIATRY, vol. 19:375, JPN6025005378, November 2019 (2019-11-01), ISSN: 0005529925 *
EUR J CLIN PHARMACOL, vol. 71:441-447, JPN6025005382, 2015, ISSN: 0005677454 *
PSY CLIN NEUROSCI, vol. 73:613-627, JPN6025005381, June 2019 (2019-06-01), ISSN: 0005677453 *
WIEN KLIN WOCHENSCHR, vol. 130(9):356-366, JPN6025005380, 2018, ISSN: 0005529927 *

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US20260053757A1 (en) 2026-02-26
US20210196654A1 (en) 2021-07-01
US20230049897A1 (en) 2023-02-16

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