CA2964504C - Oral dosage form comprising a cyclopropanecarboxamide derivative for use in treating insomnia - Google Patents

Oral dosage form comprising a cyclopropanecarboxamide derivative for use in treating insomnia Download PDF

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Publication number
CA2964504C
CA2964504C CA2964504A CA2964504A CA2964504C CA 2964504 C CA2964504 C CA 2964504C CA 2964504 A CA2964504 A CA 2964504A CA 2964504 A CA2964504 A CA 2964504A CA 2964504 C CA2964504 C CA 2964504C
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CA
Canada
Prior art keywords
compound
dosage form
mean
daily dose
effective amount
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
CA2964504A
Other languages
English (en)
French (fr)
Other versions
CA2964504A1 (en
Inventor
Margaret MOLINE
Gina Pastino
Yurie Akimoto
Yasuhiro Zaima
Nobuya Suzuki
Nobuo Yoshida
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.)
Eisai R&D Management Co Ltd
Original Assignee
Eisai R&D Management Co Ltd
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 Eisai R&D Management Co Ltd filed Critical Eisai R&D Management Co Ltd
Publication of CA2964504A1 publication Critical patent/CA2964504A1/en
Application granted granted Critical
Publication of CA2964504C publication Critical patent/CA2964504C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61K31/495—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
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
    • 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
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • 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
    • A61P25/20—Hypnotics; Sedatives

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Anesthesiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Saccharide Compounds (AREA)
CA2964504A 2014-10-23 2015-10-21 Oral dosage form comprising a cyclopropanecarboxamide derivative for use in treating insomnia Active CA2964504C (en)

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
CA2964504A1 CA2964504A1 (en) 2016-04-28
CA2964504C true CA2964504C (en) 2022-08-23

Family

ID=55761025

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2964504A Active CA2964504C (en) 2014-10-23 2015-10-21 Oral dosage form comprising a cyclopropanecarboxamide derivative for use in treating insomnia

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) SG11201703064WA (enExample)
WO (1) WO2016063995A1 (enExample)

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JP6659681B2 (ja) 2014-10-23 2020-03-04 エーザイ・アール・アンド・ディー・マネジメント株式会社 不眠症を治療するための組成物および方法
RU2763493C2 (ru) * 2016-05-12 2021-12-29 Эйсай Ар Энд Ди Менеджмент Ко., Лтд. Способы лечения расстройств циркадного ритма сна
CN109789141B (zh) * 2016-08-10 2022-08-26 豪夫迈·罗氏有限公司 包含Akt蛋白激酶抑制剂的药物组合物
JP7179049B2 (ja) * 2017-08-01 2022-11-28 ベルゲン ファーマシューティカル、 エルエルシー オレキシン受容体拮抗薬の結晶形及びその製造方法並びに用途
KR20210124188A (ko) 2018-11-21 2021-10-14 트루모 파마슈티칼스, 인크. 정제된 형태의 로페콕시브, 제조 및 사용 방법
MX2021016090A (es) * 2019-06-26 2022-02-03 Eisai R&D Man Co Ltd Lemborexant para el tratamiento de problemas del sueño.
WO2020263253A1 (en) * 2019-06-26 2020-12-30 Moline Margaret Lemborexant for treating sleep issues
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
KR20220061950A (ko) 2019-09-13 2022-05-13 에자이 알앤드디 매니지먼트 가부시키가이샤 불면증을 치료하기 위한 약제학적 조성물
WO2021048822A1 (en) * 2019-09-13 2021-03-18 Takeda Pharmaceutical Company Limited Tak-925 for use in treating narcolepsy
EP4076463A1 (en) * 2019-12-20 2022-10-26 Eisai R&D Management Co., Ltd. Use of lemborexant for treating insomnia
IL328515A (en) 2020-01-16 2026-07-01 Eisai R&D Man Co Ltd Lamborxant drug substance and medical preparation containing it
MX2022011179A (es) 2020-04-19 2022-10-07 Idorsia Pharmaceuticals Ltd Uso medico de 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
CN120076808A (zh) 2022-09-23 2025-05-30 卫材R&D管理有限公司 减少与神经退行性疾病相关的神经退行性变的方法

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JPH06328057A (ja) 1993-05-26 1994-11-29 Sanyo Electric Co Ltd 厨芥処理装置
EP0828751A4 (en) 1995-05-05 1999-01-20 Human Genome Sciences Inc HUMAN NEUROPEPTIDE RECEPTOR
US6001963A (en) 1996-12-17 1999-12-14 Smithkline Beecham Corporation Ligands of the neuropeptide receptor HFGAN72
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US6166193A (en) 1997-07-25 2000-12-26 Board Of Regents, University Of Texas System Polynucleotides encoding MY1 receptor
RU2378257C2 (ru) 2004-03-01 2010-01-10 Актелион Фармасьютиклз Лтд Замещенные производные 1,2,3,4-тетрагидроизохинолина
WO2006033005A2 (en) 2004-09-23 2006-03-30 Pfizer Products Inc. Thrombopoietin receptor agonists
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
EA015256B1 (ru) 2006-03-15 2011-06-30 Актелион Фармасьютикалз Лтд. Производные тетрагидроизохинолина для повышения функции памяти
WO2007129188A1 (en) 2006-05-10 2007-11-15 Pfizer Japan Inc. Cyclopropanecarboxamide compound
CA2662538A1 (en) 2006-09-11 2008-03-20 Glaxo Group Limited Azabicyclic compounds as inhibitors of monoamines reuptake
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
AR064561A1 (es) 2006-12-28 2009-04-08 Actelion Pharmaceuticals Ltd Derivados de 2-aza-biciclo[3.1.0]hexano y su uso en la preparacion de un medicamento para el tratamiento de enfermedades relacionadas con disfunciones generales del sistema de la orexina.
MX2010002419A (es) 2007-09-21 2010-03-30 Sanofi Aventis (ciclopropilfenil) feniloxamidas, metodo para su produccion y uso como un medicamento.
PE20091010A1 (es) 2007-10-10 2009-08-08 Actelion Pharmaceuticals Ltd Derivados de tetrahidroquinolina
CN102742210B (zh) * 2010-02-15 2015-11-25 皇家飞利浦电子股份有限公司 用于减轻控制信道干扰的装置和方法
RU2571414C2 (ru) * 2010-09-22 2015-12-20 Эйсай Ар Энд Ди Менеджмент Ко., Лтд. Циклопропановые соединения
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JP6659681B2 (ja) 2014-10-23 2020-03-04 エーザイ・アール・アンド・ディー・マネジメント株式会社 不眠症を治療するための組成物および方法

Also Published As

Publication number Publication date
IL251759A0 (en) 2017-06-29
US10702529B2 (en) 2020-07-07
EP3209298A1 (en) 2017-08-30
RU2703297C2 (ru) 2019-10-16
JP2017531683A (ja) 2017-10-26
AU2015336463B2 (en) 2020-06-18
US20200268754A1 (en) 2020-08-27
BR112017007063A2 (pt) 2018-02-14
JP6659681B2 (ja) 2020-03-04
WO2016063995A1 (en) 2016-04-28
SG11201703064WA (en) 2017-05-30
US20190201399A1 (en) 2019-07-04
RU2017112308A3 (enExample) 2019-05-08
SG10202007759RA (en) 2020-09-29
KR102444608B1 (ko) 2022-09-20
US20170252342A1 (en) 2017-09-07
KR20170068478A (ko) 2017-06-19
CA2964504A1 (en) 2016-04-28
AU2015336463A1 (en) 2017-05-04
MX376164B (es) 2025-03-07
EP3209298A4 (en) 2018-06-20
CN107810006A (zh) 2018-03-16
US11026944B2 (en) 2021-06-08
ES2843952T3 (es) 2021-07-21
CN107810006B (zh) 2021-03-30
IL251759B (en) 2021-01-31
RU2017112308A (ru) 2018-11-26
MX2017004950A (es) 2018-01-16
EP3209298B1 (en) 2020-12-02
US10188652B2 (en) 2019-01-29

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