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

    • 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

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)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Anesthesiology (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
WO2017197160A1 (en) * 2016-05-12 2017-11-16 Eisai R&D Management Co., Ltd. Methods of treating circadian rhythm sleep disorders
CN115350192B (zh) * 2016-08-10 2025-05-13 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
CN113660934A (zh) 2018-11-21 2021-11-16 特默罗制药股份有限公司 罗非昔布的纯化形式、制备方法和用途
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
WO2020263253A1 (en) * 2019-06-26 2020-12-30 Moline Margaret Lemborexant for treating sleep issues
CN114096251A (zh) * 2019-06-26 2022-02-25 卫材R&D管理有限公司 用于治疗睡眠问题的莱博雷生
CA3154321A1 (en) * 2019-09-13 2021-03-18 Takeda Pharmaceutical Company Limited Tak-925 for use in treating narcolepsy
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
BR112022012246A2 (pt) 2019-12-20 2022-08-30 Eisai R&D Man Co Ltd Uso de lemborexant para tratar insônia
US20230103250A1 (en) * 2020-01-16 2023-03-30 Eisai R&D Management Co., Ltd. Drug substance of lemborexant and medicinal composition comprising same
US20230134935A1 (en) * 2020-04-19 2023-05-04 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
KR20250070087A (ko) 2022-09-23 2025-05-20 에자이 알앤드디 매니지먼트 가부시키가이샤 신경변성 질병과 관련된 신경변성의 감소 방법

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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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WO2005118548A1 (en) 2004-03-01 2005-12-15 Actelion Pharmaceuticals Ltd Substituted 1,2,3,4-tetrahydroisoquinoline derivatives
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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
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WO2007129188A1 (en) 2006-05-10 2007-11-15 Pfizer Japan Inc. Cyclopropanecarboxamide compound
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JP2010504957A (ja) 2006-09-29 2010-02-18 アクテリオン ファーマシューティカルズ リミテッド 3−アザ−ビシクロ[3.1.0]ヘキサン誘導体
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
BRPI0817198A2 (pt) 2007-09-21 2015-03-17 Sanofi Aventis (ciclopropilfenil)feniloxalamidas, método para a produção das mesmas, e uso das mesmas como um medicamento
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KR101823339B1 (ko) * 2010-02-15 2018-01-31 코닌클리케 필립스 엔.브이. 제어 채널 간섭의 완화
SI2626350T1 (sl) * 2010-09-22 2015-09-30 Eisai R&D Management Co., Ltd. Spojina ciklopropana
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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
WO2016063995A1 (en) 2016-04-28
ES2843952T3 (es) 2021-07-21
KR20170068478A (ko) 2017-06-19
US20190201399A1 (en) 2019-07-04
MX376164B (es) 2025-03-07
KR102444608B1 (ko) 2022-09-20
EP3209298A1 (en) 2017-08-30
EP3209298A4 (en) 2018-06-20
CA2964504A1 (en) 2016-04-28
US20200268754A1 (en) 2020-08-27
JP6659681B2 (ja) 2020-03-04
SG10202007759RA (en) 2020-09-29
CN107810006B (zh) 2021-03-30
US11026944B2 (en) 2021-06-08
IL251759A0 (en) 2017-06-29
US10188652B2 (en) 2019-01-29
BR112017007063A2 (pt) 2018-02-14
MX2017004950A (es) 2018-01-16
AU2015336463B2 (en) 2020-06-18
JP2017531683A (ja) 2017-10-26
RU2017112308A3 (enExample) 2019-05-08
SG11201703064WA (en) 2017-05-30
RU2703297C2 (ru) 2019-10-16
AU2015336463A1 (en) 2017-05-04
EP3209298B1 (en) 2020-12-02
US20170252342A1 (en) 2017-09-07
US10702529B2 (en) 2020-07-07
CN107810006A (zh) 2018-03-16
RU2017112308A (ru) 2018-11-26
IL251759B (en) 2021-01-31

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