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)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Anesthesiology (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurology (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) 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
ES2843952T3 (es) 2014-10-23 2021-07-21 Eisai R&D Man Co Ltd Composiciones para tratar el insomnio
US11096941B2 (en) * 2016-05-12 2021-08-24 Eisai R&D Management Co.. Ltd. Methods of treating circadian rhythm sleep disorders
BR112019002007B1 (pt) 2016-08-10 2024-01-16 F. Hoffmann-La Roche Ag Composição farmacêutica e uso de uma composição farmacêutica
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
JP7291220B2 (ja) 2018-11-21 2023-06-14 トレモ― ファーマシューティカルズ,インコーポレーテッド ロフェコキシブの精製形態、製造方法および使用
BR112021026291A2 (pt) * 2019-06-26 2022-03-03 Eisai R&D Man Co Ltd Lemborexant para tratar problemas de sono
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
CA3154321A1 (en) * 2019-09-13 2021-03-18 Takeda Pharmaceutical Company Limited Tak-925 for use in treating narcolepsy
JP7573015B2 (ja) * 2019-09-13 2024-10-24 エーザイ・アール・アンド・ディー・マネジメント株式会社 不眠症治療用医薬組成物
MX2022007304A (es) * 2019-12-20 2022-08-22 Eisai R&D Man Co Ltd Uso de lemborexant para tratamiento del insomnio.
MX2022008260A (es) * 2020-01-16 2022-08-04 Eisai R&D Man Co Ltd Sustancia farmacologica de lemborexant y composicion medicinal que la comprende.
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

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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
US6309854B1 (en) 1996-12-17 2001-10-30 Smithkline Beecham Corporation Polynucleotides encoding ligands of the neuropeptide receptor HFGAN72
US6001963A (en) 1996-12-17 1999-12-14 Smithkline Beecham Corporation Ligands of the neuropeptide receptor HFGAN72
US6020157A (en) 1997-04-30 2000-02-01 Smithkline Beecham Corporation Polynucleotides encoding HFGAN72X receptor
US5935814A (en) 1997-04-30 1999-08-10 Smithkline Beecham Corporation Polynucleotides encoding HFGAN72Y receptor
US6166193A (en) 1997-07-25 2000-12-26 Board Of Regents, University Of Texas System Polynucleotides encoding MY1 receptor
CA2557163C (en) 2004-03-01 2011-08-16 Idorsia Pharmaceuticals Ltd Substituted 1,2,3,4-tetrahydroisoquinoline derivatives
MX2007003377A (es) 2004-09-23 2007-05-10 Pfizer Prod Inc Agonistas del receptor de trombopoyetina.
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
AU2007226203A1 (en) 2006-03-15 2007-09-20 Actelion Pharmaceuticals Ltd Tetrahydroisoquinoline derivatives to enhance memory function
WO2007129188A1 (en) 2006-05-10 2007-11-15 Pfizer Japan Inc. Cyclopropanecarboxamide compound
WO2008031772A1 (en) 2006-09-11 2008-03-20 Glaxo Group Limited Azabicyclic compounds as inhibitors of monoamines reuptake
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
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PE20091010A1 (es) 2007-10-10 2009-08-08 Actelion Pharmaceuticals Ltd Derivados de tetrahidroquinolina
JP5735010B2 (ja) * 2010-02-15 2015-06-17 コーニンクレッカ フィリップス エヌ ヴェ 制御チャネル干渉の軽減
AU2011304285B2 (en) * 2010-09-22 2015-01-29 Eisai R&D Management Co., Ltd. Cyclopropane compound
US20120165339A1 (en) 2010-12-22 2012-06-28 Eisai R&D Management Co., Ltd. Cyclopropane derivatives
ES2843952T3 (es) 2014-10-23 2021-07-21 Eisai R&D Man Co Ltd Composiciones para tratar el insomnio

Also Published As

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

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