AU2015336463B2 - Compositions and methods for treating insomnia - Google Patents

Compositions and methods for treating insomnia Download PDF

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Publication number
AU2015336463B2
AU2015336463B2 AU2015336463A AU2015336463A AU2015336463B2 AU 2015336463 B2 AU2015336463 B2 AU 2015336463B2 AU 2015336463 A AU2015336463 A AU 2015336463A AU 2015336463 A AU2015336463 A AU 2015336463A AU 2015336463 B2 AU2015336463 B2 AU 2015336463B2
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AU
Australia
Prior art keywords
compound
daily dose
dosage form
mean
effective amount
Prior art date
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Active, expires
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AU2015336463A
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English (en)
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AU2015336463A1 (en
Inventor
Yurie Akimoto
Margaret MOLINE
Gina Pastino
Nobuya Suzuki
Nobuo Yoshida
Yasuhiro Zaima
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
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Eisai R&D Management Co Ltd
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Publication of AU2015336463A1 publication Critical patent/AU2015336463A1/en
Application granted granted Critical
Publication of AU2015336463B2 publication Critical patent/AU2015336463B2/en
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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)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Neurosurgery (AREA)
  • Anesthesiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Neurology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biomedical Technology (AREA)
  • Inorganic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Saccharide Compounds (AREA)
AU2015336463A 2014-10-23 2015-10-21 Compositions and methods for treating insomnia Active 2036-07-16 AU2015336463B2 (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
AU2015336463A1 AU2015336463A1 (en) 2017-05-04
AU2015336463B2 true AU2015336463B2 (en) 2020-06-18

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
AU2015336463A Active 2036-07-16 AU2015336463B2 (en) 2014-10-23 2015-10-21 Compositions and methods for treating insomnia

Country Status (14)

Country Link
US (3) US10188652B2 (cg-RX-API-DMAC7.html)
EP (1) EP3209298B1 (cg-RX-API-DMAC7.html)
JP (1) JP6659681B2 (cg-RX-API-DMAC7.html)
KR (1) KR102444608B1 (cg-RX-API-DMAC7.html)
CN (1) CN107810006B (cg-RX-API-DMAC7.html)
AU (1) AU2015336463B2 (cg-RX-API-DMAC7.html)
BR (1) BR112017007063A2 (cg-RX-API-DMAC7.html)
CA (1) CA2964504C (cg-RX-API-DMAC7.html)
ES (1) ES2843952T3 (cg-RX-API-DMAC7.html)
IL (1) IL251759B (cg-RX-API-DMAC7.html)
MX (1) MX376164B (cg-RX-API-DMAC7.html)
RU (1) RU2703297C2 (cg-RX-API-DMAC7.html)
SG (2) SG10202007759RA (cg-RX-API-DMAC7.html)
WO (1) WO2016063995A1 (cg-RX-API-DMAC7.html)

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RU2703297C2 (ru) 2014-10-23 2019-10-16 Эйсай Ар Энд Ди Менеджмент Ко., Лтд. Композиции и способы для лечения бессонницы
SG11201809527UA (en) * 2016-05-12 2018-11-29 Eisai R&D Man Co Ltd Methods of treating circadian rhythm sleep disorders
EP4613333A3 (en) 2016-08-10 2025-10-29 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
MX2021005967A (es) 2018-11-21 2021-10-13 Tremeau Pharmaceuticals Inc Formas purificadas de rofecoxib, métodos de fabricación y uso.
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
MX2021016090A (es) * 2019-06-26 2022-02-03 Eisai R&D Man Co Ltd Lemborexant para el tratamiento de problemas del sueño.
KR20220062012A (ko) * 2019-09-13 2022-05-13 다케다 야쿠힌 고교 가부시키가이샤 기면증 치료에 사용하기 위한 tak-925
WO2021050219A1 (en) * 2019-09-13 2021-03-18 Eisai R&D Management Co., Ltd. Pharmaceutical composition for treating insomnia
US20230051268A1 (en) * 2019-12-20 2023-02-16 Eisai R&D Management Co., Ltd. Use of lemborexant for treating insomnia
MX2022008260A (es) 2020-01-16 2022-08-04 Eisai R&D Man Co Ltd Sustancia farmacologica de lemborexant y composicion medicinal que la comprende.
PH12022552763A1 (en) 2020-04-19 2024-03-25 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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Also Published As

Publication number Publication date
US10702529B2 (en) 2020-07-07
US10188652B2 (en) 2019-01-29
US20170252342A1 (en) 2017-09-07
IL251759A0 (en) 2017-06-29
RU2017112308A (ru) 2018-11-26
CN107810006A (zh) 2018-03-16
CA2964504C (en) 2022-08-23
MX2017004950A (es) 2018-01-16
KR20170068478A (ko) 2017-06-19
JP6659681B2 (ja) 2020-03-04
RU2017112308A3 (cg-RX-API-DMAC7.html) 2019-05-08
EP3209298B1 (en) 2020-12-02
EP3209298A1 (en) 2017-08-30
WO2016063995A1 (en) 2016-04-28
SG10202007759RA (en) 2020-09-29
US11026944B2 (en) 2021-06-08
US20190201399A1 (en) 2019-07-04
EP3209298A4 (en) 2018-06-20
IL251759B (en) 2021-01-31
US20200268754A1 (en) 2020-08-27
AU2015336463A1 (en) 2017-05-04
CN107810006B (zh) 2021-03-30
RU2703297C2 (ru) 2019-10-16
KR102444608B1 (ko) 2022-09-20
CA2964504A1 (en) 2016-04-28
SG11201703064WA (en) 2017-05-30
BR112017007063A2 (pt) 2018-02-14
ES2843952T3 (es) 2021-07-21
JP2017531683A (ja) 2017-10-26
MX376164B (es) 2025-03-07

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Filing date: 20210716

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Filing date: 20210716