KR102444608B1 - 불면증을 치료하기 위한 조성물 및 방법 - Google Patents

불면증을 치료하기 위한 조성물 및 방법 Download PDF

Info

Publication number
KR102444608B1
KR102444608B1 KR1020177009858A KR20177009858A KR102444608B1 KR 102444608 B1 KR102444608 B1 KR 102444608B1 KR 1020177009858 A KR1020177009858 A KR 1020177009858A KR 20177009858 A KR20177009858 A KR 20177009858A KR 102444608 B1 KR102444608 B1 KR 102444608B1
Authority
KR
South Korea
Prior art keywords
compound
dosage form
dose
effective amount
daily dose
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.)
Active
Application number
KR1020177009858A
Other languages
English (en)
Korean (ko)
Other versions
KR20170068478A (ko
Inventor
마가렛 몰린
지나 파스티노
유리에 아키모토
야스히로 자이마
노부야 스즈키
노부오 요시다
Original Assignee
에자이 알앤드디 매니지먼트 가부시키가이샤
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 에자이 알앤드디 매니지먼트 가부시키가이샤 filed Critical 에자이 알앤드디 매니지먼트 가부시키가이샤
Publication of KR20170068478A publication Critical patent/KR20170068478A/ko
Application granted granted Critical
Publication of KR102444608B1 publication Critical patent/KR102444608B1/ko
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

Classifications

    • 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
    • A61K31/495Heterocyclic 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
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/506Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • 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
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4858Organic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4866Organic macromolecular compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/20Hypnotics; Sedatives
    • Y10S514/923

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Engineering & Computer Science (AREA)
  • Neurology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Neurosurgery (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Saccharide Compounds (AREA)
KR1020177009858A 2014-10-23 2015-10-21 불면증을 치료하기 위한 조성물 및 방법 Active KR102444608B1 (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201462067443P 2014-10-23 2014-10-23
US62/067,443 2014-10-23
PCT/JP2015/080304 WO2016063995A1 (en) 2014-10-23 2015-10-21 Compositions and methods for treating insomnia

Publications (2)

Publication Number Publication Date
KR20170068478A KR20170068478A (ko) 2017-06-19
KR102444608B1 true KR102444608B1 (ko) 2022-09-20

Family

ID=55761025

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020177009858A Active KR102444608B1 (ko) 2014-10-23 2015-10-21 불면증을 치료하기 위한 조성물 및 방법

Country Status (14)

Country Link
US (3) US10188652B2 (enExample)
EP (1) EP3209298B1 (enExample)
JP (1) JP6659681B2 (enExample)
KR (1) KR102444608B1 (enExample)
CN (1) CN107810006B (enExample)
AU (1) AU2015336463B2 (enExample)
BR (1) BR112017007063A2 (enExample)
CA (1) CA2964504C (enExample)
ES (1) ES2843952T3 (enExample)
IL (1) IL251759B (enExample)
MX (1) MX376164B (enExample)
RU (1) RU2703297C2 (enExample)
SG (2) SG10202007759RA (enExample)
WO (1) WO2016063995A1 (enExample)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SG10202007759RA (en) 2014-10-23 2020-09-29 Eisai R&D Man Co Ltd Compositions and methods for treating insomnia
IL291791B2 (en) * 2016-05-12 2025-09-01 Eisai R&D Man Co Ltd Methods for treating sleep timing disorders
CA3032233C (en) 2016-08-10 2021-09-14 F. Hoffmann-La Roche Ag Pharmaceutical compositions comprising akt protein kinase inhibitors
CN115710250A (zh) 2017-08-01 2023-02-24 博健制药有限责任公司 一种食欲素受体拮抗剂的晶型及其制备方法和用途
CA3119728A1 (en) 2018-11-21 2020-05-28 Tremeau Pharmaceuticals, Inc. Purified forms of rofecoxib, methods of manufacture and use
JP2022538170A (ja) * 2019-06-26 2022-08-31 エーザイ・アール・アンド・ディー・マネジメント株式会社 睡眠問題の治療のためのレンボレキサント
US20220305012A1 (en) * 2019-06-26 2022-09-29 Eisai R&D Management Co., Ltd. Lemborexant for treating sleep issues
WO2020263253A1 (en) * 2019-06-26 2020-12-30 Moline Margaret Lemborexant for treating sleep issues
CN114502167A (zh) * 2019-09-13 2022-05-13 卫材R&D管理有限公司 用于治疗失眠的药物组合物
US20220339143A1 (en) * 2019-09-13 2022-10-27 Takeda Pharmaceutical Company Limited Tak-925 for use in treating narcolepsy
KR20220119065A (ko) 2019-12-20 2022-08-26 에자이 알앤드디 매니지먼트 가부시키가이샤 불면증 치료를 위한 렘보렉산트의 용도
TW202140014A (zh) 2020-01-16 2021-11-01 日商衛材R&D企管股份有限公司 萊博雷生的原料藥及含有其的醫藥組成物
EP4138822A1 (en) 2020-04-19 2023-03-01 Idorsia Pharmaceuticals Ltd Medical use of daridorexant
CN111450076A (zh) * 2020-05-25 2020-07-28 安徽省逸欣铭医药科技有限公司 一种Lemborexant软胶囊组合物及其制备方法
WO2024064897A1 (en) 2022-09-23 2024-03-28 Eisai R&D Management Co., Ltd. Methods of reducing neurodegeneration associated with neurodegenerative diseases

Family Cites Families (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH06328057A (ja) 1993-05-26 1994-11-29 Sanyo Electric Co Ltd 厨芥処理装置
CA2220036A1 (en) 1995-05-05 1996-11-07 Human Genome Sciences, Inc. Human neuropeptide receptor
US6001963A (en) 1996-12-17 1999-12-14 Smithkline Beecham Corporation Ligands of the neuropeptide receptor HFGAN72
US6309854B1 (en) 1996-12-17 2001-10-30 Smithkline Beecham Corporation Polynucleotides encoding ligands of the neuropeptide receptor HFGAN72
US5935814A (en) 1997-04-30 1999-08-10 Smithkline Beecham Corporation Polynucleotides encoding HFGAN72Y receptor
US6020157A (en) 1997-04-30 2000-02-01 Smithkline Beecham Corporation Polynucleotides encoding HFGAN72X receptor
US6166193A (en) 1997-07-25 2000-12-26 Board Of Regents, University Of Texas System Polynucleotides encoding MY1 receptor
JP4094050B2 (ja) 2004-03-01 2008-06-04 アクテリオン ファーマシューティカルズ リミテッド 置換1,2,3,4−テトラヒドロイソキノリン誘導体
BRPI0515571A (pt) 2004-09-23 2008-07-29 Pfizer Prod Inc agonistas de receptor de trombopoetina
JP2006328057A (ja) 2005-04-25 2006-12-07 Eisai R & D Management Co Ltd 抗不安薬及びそのスクリーニング方法
EP1998774A1 (en) 2006-03-15 2008-12-10 Actelion Pharmaceuticals Ltd. Tetrahydroisoquinoline derivatives to enhance memory function
WO2007129188A1 (en) 2006-05-10 2007-11-15 Pfizer Japan Inc. Cyclopropanecarboxamide compound
BRPI0716532A2 (pt) 2006-09-11 2013-09-24 Glaxo Group Ltd compostos azabicÍclios como inidores de reabsorÇço de monoaminas
CL2007002809A1 (es) 2006-09-29 2008-04-18 Actelion Pharmaceuticals Ltd Compuestos derivados de 3-aza biciclo [3.1.0]hexano; y su uso en el tratamiento de enfermedades tales como desordenes psicoticos y de ansiedad, desordenes del sueno, uso y abuso de sustancias psicoactivas, demencia y deterioro de funciones cognitivas
PE20081229A1 (es) 2006-12-01 2008-08-28 Merck & Co Inc Antagonistas de receptor de orexina de diazepam sustituido
TW200833328A (en) 2006-12-28 2008-08-16 Actelion Pharmaceuticals Ltd 2-aza-bicyclo[3.1.0]hexane derivatives
AU2008303975B2 (en) 2007-09-21 2013-05-16 Sanofi (Cyclopropyl-phenyl)-phenyl-oxalamides, method for the production thereof, and use of same as a medicament
PE20091010A1 (es) 2007-10-10 2009-08-08 Actelion Pharmaceuticals Ltd Derivados de tetrahidroquinolina
EP2537282B1 (en) * 2010-02-15 2015-09-16 Koninklijke Philips N.V. Mitigation of control channel interference
SI2626350T1 (sl) * 2010-09-22 2015-09-30 Eisai R&D Management Co., Ltd. Spojina ciklopropana
US20120165339A1 (en) 2010-12-22 2012-06-28 Eisai R&D Management Co., Ltd. Cyclopropane derivatives
SG10202007759RA (en) 2014-10-23 2020-09-29 Eisai R&D Man Co Ltd Compositions and methods for treating insomnia

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
US FDA, Guidance for Industry Estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers, 2005. (2005.07.31.)*

Also Published As

Publication number Publication date
JP6659681B2 (ja) 2020-03-04
EP3209298A4 (en) 2018-06-20
RU2703297C2 (ru) 2019-10-16
BR112017007063A2 (pt) 2018-02-14
US11026944B2 (en) 2021-06-08
US20200268754A1 (en) 2020-08-27
IL251759B (en) 2021-01-31
WO2016063995A1 (en) 2016-04-28
CN107810006B (zh) 2021-03-30
US20170252342A1 (en) 2017-09-07
RU2017112308A3 (enExample) 2019-05-08
SG10202007759RA (en) 2020-09-29
RU2017112308A (ru) 2018-11-26
CA2964504A1 (en) 2016-04-28
KR20170068478A (ko) 2017-06-19
MX376164B (es) 2025-03-07
ES2843952T3 (es) 2021-07-21
SG11201703064WA (en) 2017-05-30
AU2015336463A1 (en) 2017-05-04
MX2017004950A (es) 2018-01-16
CA2964504C (en) 2022-08-23
EP3209298B1 (en) 2020-12-02
JP2017531683A (ja) 2017-10-26
US20190201399A1 (en) 2019-07-04
CN107810006A (zh) 2018-03-16
EP3209298A1 (en) 2017-08-30
US10702529B2 (en) 2020-07-07
IL251759A0 (en) 2017-06-29
AU2015336463B2 (en) 2020-06-18
US10188652B2 (en) 2019-01-29

Similar Documents

Publication Publication Date Title
US11026944B2 (en) Compositions and methods for treating insomnia
JP5886632B2 (ja) オキシコドンおよびナロキソンを含む即時放出医薬組成物
JP5914626B2 (ja) 徐放性アミノピリジン組成物の使用方法
KR20070107805A (ko) 옥시코돈 및 날록손 함유 제형
TW202116314A (zh) T型鈣離子通道調節劑之調配物及其使用方法
US20250387382A1 (en) Methods of treating essential tremor
EP1455786A1 (en) Use of a compound in the treatment of sleep disorders and the like in providing refreshedness on waking and a method for the treatment of grogginess therewith
CA3017374A1 (en) Treatment of uremic pruritus
CN102600146B (zh) 一种盐酸乐卡地平和氯沙坦钾复方制剂及其制备方法
TW200916091A (en) Neramexane for the treatment of nystagmus
WO2026085384A1 (en) Methods of treating essential tremor
JP5226732B2 (ja) 催眠用圧縮成型製剤
AU2024348342A1 (en) Method of treating post-traumatic stress disorder
WO2025188619A1 (en) Methods of treating parkinson's disease with t-type calcium channel modulators
EA051790B1 (ru) Композиция кофеина с пульсирующим высвобождением
WO2011051423A1 (en) Treatment or prophylaxis of dementia, neurodegenerative disorders, schizophrenia, adhd, somnolence or epilepsy
KR20120103521A (ko) 에페리손 함유 필름코팅정제, 및 이의 제조방법

Legal Events

Date Code Title Description
PA0105 International application

Patent event date: 20170412

Patent event code: PA01051R01D

Comment text: International Patent Application

PG1501 Laying open of application
A201 Request for examination
PA0201 Request for examination

Patent event code: PA02012R01D

Patent event date: 20200806

Comment text: Request for Examination of Application

E902 Notification of reason for refusal
PE0902 Notice of grounds for rejection

Comment text: Notification of reason for refusal

Patent event date: 20220513

Patent event code: PE09021S01D

E701 Decision to grant or registration of patent right
PE0701 Decision of registration

Patent event code: PE07011S01D

Comment text: Decision to Grant Registration

Patent event date: 20220804

GRNT Written decision to grant
PR0701 Registration of establishment

Comment text: Registration of Establishment

Patent event date: 20220914

Patent event code: PR07011E01D

PR1002 Payment of registration fee

Payment date: 20220915

End annual number: 3

Start annual number: 1

PG1601 Publication of registration