AU2015336463B2 - Compositions and methods for treating insomnia - Google Patents
Compositions and methods for treating insomnia Download PDFInfo
- 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
- Authority
- AU
- Australia
- Prior art keywords
- compound
- daily dose
- dosage form
- mean
- 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, expires
Links
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)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Physiology (AREA)
- Nutrition Science (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- General Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Anesthesiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Biomedical Technology (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Inorganic Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Saccharide Compounds (AREA)
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
ID=55761025
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 (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)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU2015336463B2 (en) | 2014-10-23 | 2020-06-18 | Eisai R&D Management Co., Ltd. | Compositions and methods for treating insomnia |
| MX379318B (es) * | 2016-05-12 | 2025-03-10 | Eisai R&D Man Co Ltd | Metodos para tratar trastornos de sueño de ritmo circadiano. |
| TWI855386B (zh) | 2016-08-10 | 2024-09-11 | 瑞士商赫孚孟拉羅股份公司 | 包含Ａｋｔ蛋白質激酶抑制劑之醫藥組合物 |
| 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 |
| EP3883562A4 (en) | 2018-11-21 | 2022-08-03 | Tremeau Pharmaceuticals, Inc. | PURIFIED FORMS OF ROFECOXIB AND METHODS OF MAKING AND USING |
| 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 |
| 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 |
| AU2020346456A1 (en) * | 2019-09-13 | 2022-04-14 | Takeda Pharmaceutical Company Limited | TAK-925 for use in treating narcolepsy |
| WO2021050219A1 (en) * | 2019-09-13 | 2021-03-18 | Eisai R&D Management Co., Ltd. | Pharmaceutical composition for treating insomnia |
| EP4076463A1 (en) * | 2019-12-20 | 2022-10-26 | Eisai R&D Management Co., Ltd. | Use of lemborexant for treating insomnia |
| CA3164198A1 (en) * | 2020-01-16 | 2021-07-22 | Eisai R&D Management Co., Ltd. | Drug substance of lemborexant and medicinal composition comprising same |
| JP2023521492A (ja) | 2020-04-19 | 2023-05-24 | イドーシア ファーマシューティカルズ リミテッド | ダリドレキサントの医学的用途 |
| 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 |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20120095031A1 (en) * | 2010-09-22 | 2012-04-19 | Eisai R&D Management Co., Ltd. | Cyclopropane compound |
Family Cites Families (21)
| 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 |
| WO1996034877A1 (en) | 1995-05-05 | 1996-11-07 | 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 |
| US7763638B2 (en) | 2004-03-01 | 2010-07-27 | Actelion Pharmaceuticals Ltd. | Substituted 1,2,3,4-tetrahydroisoquinoline derivatives |
| 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 |
| 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 |
| MX2009002625A (es) | 2006-09-11 | 2009-03-24 | Glaxo Group Ltd | Compuestos azabiciclicos como inhibidores de la recaptacion de monoaminas. |
| KR20090077051A (ko) | 2006-09-29 | 2009-07-14 | 액테리온 파마슈티칼 리미티드 | 3-아자-비시클로[3.1.0]헥산 유도체 |
| 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 |
| WO2011098955A1 (en) * | 2010-02-15 | 2011-08-18 | Koninklijke Philips Electronics N.V. | Mitigation of control channel interference |
| US20120165339A1 (en) | 2010-12-22 | 2012-06-28 | Eisai R&D Management Co., Ltd. | Cyclopropane derivatives |
| AU2015336463B2 (en) | 2014-10-23 | 2020-06-18 | Eisai R&D Management Co., Ltd. | Compositions and methods for treating insomnia |
-
2015
- 2015-10-21 AU AU2015336463A patent/AU2015336463B2/en active Active
- 2015-10-21 EP EP15851934.8A patent/EP3209298B1/en active Active
- 2015-10-21 JP JP2017522213A patent/JP6659681B2/ja active Active
- 2015-10-21 CN CN201580055472.XA patent/CN107810006B/zh active Active
- 2015-10-21 KR KR1020177009858A patent/KR102444608B1/ko active Active
- 2015-10-21 US US15/519,676 patent/US10188652B2/en active Active
- 2015-10-21 SG SG10202007759RA patent/SG10202007759RA/en unknown
- 2015-10-21 CA CA2964504A patent/CA2964504C/en active Active
- 2015-10-21 WO PCT/JP2015/080304 patent/WO2016063995A1/en not_active Ceased
- 2015-10-21 RU RU2017112308A patent/RU2703297C2/ru active
- 2015-10-21 BR BR112017007063-4A patent/BR112017007063A2/pt not_active Application Discontinuation
- 2015-10-21 SG SG11201703064WA patent/SG11201703064WA/en unknown
- 2015-10-21 MX MX2017004950A patent/MX376164B/es active IP Right Grant
- 2015-10-21 ES ES15851934T patent/ES2843952T3/es active Active
-
2017
- 2017-04-18 IL IL251759A patent/IL251759B/en active IP Right Grant
-
2019
- 2019-01-23 US US16/255,116 patent/US10702529B2/en active Active
-
2020
- 2020-03-16 US US16/819,341 patent/US11026944B2/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20120095031A1 (en) * | 2010-09-22 | 2012-04-19 | Eisai R&D Management Co., Ltd. | Cyclopropane compound |
Non-Patent Citations (1)
| Title |
|---|
| BETTICA, P. et al. "Phase I studies on the safety, tolerability, pharmacokinetics and pharmacodynamics of SB-649868, a novel dual orexin receptor antagonist" Journal of Psychopharmacology (2012) Vol.26 No.8, pages 1058 to 1070 * |
Also Published As
| Publication number | Publication date |
|---|---|
| AU2015336463A1 (en) | 2017-05-04 |
| CA2964504C (en) | 2022-08-23 |
| JP2017531683A (ja) | 2017-10-26 |
| MX376164B (es) | 2025-03-07 |
| KR102444608B1 (ko) | 2022-09-20 |
| CA2964504A1 (en) | 2016-04-28 |
| US10702529B2 (en) | 2020-07-07 |
| EP3209298B1 (en) | 2020-12-02 |
| BR112017007063A2 (pt) | 2018-02-14 |
| CN107810006A (zh) | 2018-03-16 |
| RU2017112308A3 (enExample) | 2019-05-08 |
| EP3209298A4 (en) | 2018-06-20 |
| IL251759A0 (en) | 2017-06-29 |
| MX2017004950A (es) | 2018-01-16 |
| EP3209298A1 (en) | 2017-08-30 |
| ES2843952T3 (es) | 2021-07-21 |
| US11026944B2 (en) | 2021-06-08 |
| JP6659681B2 (ja) | 2020-03-04 |
| SG11201703064WA (en) | 2017-05-30 |
| RU2703297C2 (ru) | 2019-10-16 |
| US10188652B2 (en) | 2019-01-29 |
| CN107810006B (zh) | 2021-03-30 |
| KR20170068478A (ko) | 2017-06-19 |
| RU2017112308A (ru) | 2018-11-26 |
| US20190201399A1 (en) | 2019-07-04 |
| WO2016063995A1 (en) | 2016-04-28 |
| US20170252342A1 (en) | 2017-09-07 |
| US20200268754A1 (en) | 2020-08-27 |
| SG10202007759RA (en) | 2020-09-29 |
| IL251759B (en) | 2021-01-31 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FGA | Letters patent sealed or granted (standard patent) | ||
| NC | Extension of term for standard patent requested (sect. 70) |
Free format text: PRODUCT NAME: DAYVIGO LEMBOREXANT Filing date: 20210716 |
|
| NDA | Extension of term for standard patent accepted (sect.70) |
Free format text: PRODUCT NAME: DAYVIGO LEMBOREXANT Filing date: 20210716 |