JP6231670B2 - 非鎮静性デクスメデトミジン経皮組成物を用いる、離脱症候群の治療法及び組成物 - Google Patents
非鎮静性デクスメデトミジン経皮組成物を用いる、離脱症候群の治療法及び組成物 Download PDFInfo
- Publication number
- JP6231670B2 JP6231670B2 JP2016520591A JP2016520591A JP6231670B2 JP 6231670 B2 JP6231670 B2 JP 6231670B2 JP 2016520591 A JP2016520591 A JP 2016520591A JP 2016520591 A JP2016520591 A JP 2016520591A JP 6231670 B2 JP6231670 B2 JP 6231670B2
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- Japan
- Prior art keywords
- dexmedetomidine
- delivery device
- transdermal delivery
- subject
- transdermal
- 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.)
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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
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/415—1,2-Diazoles
-
- 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
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4174—Arylalkylimidazoles, e.g. oxymetazolin, naphazoline, miconazole
-
- 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
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/417—Imidazole-alkylamines, e.g. histamine, phentolamine
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- 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
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
-
- 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
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
- A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
- A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
-
- 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
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
- A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
- A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
- A61K9/7061—Polyacrylates
-
- 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
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
-
- 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
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
- A61P25/32—Alcohol-abuse
-
- 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
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
- A61P25/34—Tobacco-abuse
-
- 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
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
- A61P25/36—Opioid-abuse
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Dermatology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Addiction (AREA)
- Biomedical Technology (AREA)
- Psychiatry (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Inorganic Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201361887871P | 2013-10-07 | 2013-10-07 | |
| US61/887,871 | 2013-10-07 | ||
| PCT/US2014/059058 WO2015054063A1 (en) | 2013-10-07 | 2014-10-03 | Methods and compositions for treating withdrawal syndromes using non-sedative dexmedetomidine transdermal compositions |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2016532643A JP2016532643A (ja) | 2016-10-20 |
| JP2016532643A5 JP2016532643A5 (https=) | 2017-09-28 |
| JP6231670B2 true JP6231670B2 (ja) | 2017-11-15 |
Family
ID=52777130
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2016520591A Active JP6231670B2 (ja) | 2013-10-07 | 2014-10-03 | 非鎮静性デクスメデトミジン経皮組成物を用いる、離脱症候群の治療法及び組成物 |
Country Status (11)
| Country | Link |
|---|---|
| US (1) | US20150098983A1 (https=) |
| EP (1) | EP3054934B1 (https=) |
| JP (1) | JP6231670B2 (https=) |
| KR (2) | KR20160055934A (https=) |
| CN (1) | CN105682650B (https=) |
| CA (1) | CA2924190C (https=) |
| ES (1) | ES2983565T3 (https=) |
| FI (1) | FI3054934T3 (https=) |
| RU (1) | RU2648817C2 (https=) |
| TW (1) | TWI624278B (https=) |
| WO (1) | WO2015054063A1 (https=) |
Families Citing this family (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2924233C (en) * | 2013-10-07 | 2018-10-23 | Teikoku Pharma Usa, Inc. | Methods and compositions for treating attention deficit hyperactivity disorder, anxiety and insomnia using dexmedetomidine transdermal compositions |
| GB201600918D0 (en) * | 2016-01-18 | 2016-03-02 | Buzzz Pharmaceuticals Ltd | Transdermal patch |
| TWI764951B (zh) * | 2016-10-31 | 2022-05-21 | 美商帝國製藥美國股份有限公司 | 用於處理疼痛之右美托咪啶經皮遞送裝置 |
| KR102793584B1 (ko) | 2016-12-31 | 2025-04-09 | 바이오엑셀 테라퓨틱스 인코포레이티드 | 불안의 치료를 위한 설하 덱스메데토미딘의 용도 |
| CN111447927A (zh) * | 2017-12-08 | 2020-07-24 | 帝国制药美国公司 | 纳洛酮经皮给药装置及其使用方法 |
| PL3813802T3 (pl) | 2018-06-27 | 2025-04-22 | Bioxcel Therapeutics, Inc. | Formulacje błony zawierające deksmedetomidynę i sposoby ich wytwarzania |
| WO2020006119A1 (en) | 2018-06-27 | 2020-01-02 | Bioxcel Therapeutics, Inc. | Methods for treating agitation using dexmedetomidine hydrochloride |
| CA3077561A1 (en) * | 2018-10-15 | 2020-04-15 | Amnon VARDI | Slow release cannabinoids and products thereof |
| US20220218689A1 (en) * | 2018-10-24 | 2022-07-14 | Saniona A/S | Transdermal tropane compositions and methods for using the same |
| US20220241218A1 (en) * | 2019-04-17 | 2022-08-04 | Lts Lohmann Therapie-Systeme Ag | Transdermal therapeutic system |
| EP3999058A4 (en) * | 2019-07-19 | 2023-05-03 | Bioxcel Therapeutics, Inc. | NON-SEDATIVE DEXMEDETOMIDINE-BASED TREATMENT REGIMEN |
| US12364692B2 (en) | 2020-02-14 | 2025-07-22 | Teikoku Pharma Usa, Inc. | Topical naloxone compositions and methods for using the same |
| EP4225305A4 (en) * | 2020-10-08 | 2024-10-23 | Bioxcel Therapeutics, Inc. | TREATMENT OF BIPOLAR DISEASES AND PSYCHOSES WITH DEXMEDETOMIDINE HYDROCHLORIDE |
| WO2022147537A1 (en) * | 2021-01-04 | 2022-07-07 | Bioxcel Therapeutics, Inc. | Dexmedetomidine treatment regimens |
| CN115227638B (zh) * | 2022-07-19 | 2025-03-18 | 广州新济生物医药研究院有限公司 | 一种盐酸右美托咪定可溶性微针及其制备方法 |
| US11806334B1 (en) | 2023-01-12 | 2023-11-07 | Bioxcel Therapeutics, Inc. | Non-sedating dexmedetomidine treatment regimens |
| AU2024253436A1 (en) * | 2023-04-04 | 2025-11-13 | Board Of Regents, The University Of Texas System | Combinations including methocinnamox |
Family Cites Families (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5124157A (en) * | 1989-08-18 | 1992-06-23 | Cygnus Therapeutic Systems | Method and device for administering dexmedetomidine transdermally |
| US5217718A (en) * | 1989-08-18 | 1993-06-08 | Cygnus Therapeutic Systems | Method and device for administering dexmedetomidine transdermally |
| GB9111732D0 (en) * | 1991-05-31 | 1991-07-24 | Orion Yhtymae Oy | The use of certain salts of medetomidine and its optically active enantiomers to regulate the rate of transdermal administration of the drugs |
| CA2222133C (en) * | 1995-06-07 | 2002-12-24 | Cygnus, Inc. | Transdermal patch and method for administering 17-deacetyl norgestimate alone or in combination with an estrogen |
| GB9521680D0 (en) * | 1995-10-23 | 1996-01-03 | Orion Yhtymo Oy | New use of imidazole derivatives |
| US5891868A (en) * | 1997-11-21 | 1999-04-06 | Kaiser Foundation Health Plan, Inc. | Methods for treating postmenopausal women using ultra-low doses of estrogen |
| NZ510771A (en) * | 1998-10-02 | 2003-08-29 | 3M Innovative Properties Co | Mucosal originated drug delivery systems |
| US20030170195A1 (en) * | 2000-01-10 | 2003-09-11 | Noven Pharmaceuticals, Inc. | Compositions and methods for drug delivery |
| JP4694967B2 (ja) * | 2003-07-31 | 2011-06-08 | 久光製薬株式会社 | 貼付剤 |
| US20090258063A1 (en) * | 2006-09-11 | 2009-10-15 | Sekisui Chemical Co., Ltd. | Transdermal patch |
| JP5547065B2 (ja) * | 2008-05-15 | 2014-07-09 | 久光製薬株式会社 | パロノセトロンを含有する経皮吸収製剤 |
| AU2011204315A1 (en) * | 2010-01-08 | 2012-08-02 | Recro Pharma, Inc. | Topical transdermal dexmedetomidine compositions and methods of use thereof |
| CN103200944B (zh) * | 2010-11-17 | 2016-05-04 | 赫克萨尔股份公司 | 包含丁丙诺啡的经皮治疗系统 |
| WO2013072763A2 (en) * | 2011-11-16 | 2013-05-23 | Nometics Inc. | Non-sensitizing transdermal clonidine patch |
| AU2012352528B9 (en) * | 2011-12-11 | 2017-11-02 | Baudax Bio, Inc. | Intranasal dexmedetomidine compositions and methods of use thereof |
| US8242158B1 (en) * | 2012-01-04 | 2012-08-14 | Hospira, Inc. | Dexmedetomidine premix formulation |
| US20130211351A1 (en) * | 2012-01-31 | 2013-08-15 | Gruenenthal Gmbh | Pharmaceutical patch for transdermal administration of (1r,4r)-6'-fluoro-N,N-dimethyl-4-phenyl-4',9'-dihydro-3'H-spiro[cyclohexane-1,1'-pyrano[3,4-b]indol]-4-amine |
-
2014
- 2014-10-03 CA CA2924190A patent/CA2924190C/en active Active
- 2014-10-03 TW TW103134526A patent/TWI624278B/zh active
- 2014-10-03 KR KR1020167010340A patent/KR20160055934A/ko not_active Ceased
- 2014-10-03 CN CN201480058703.8A patent/CN105682650B/zh active Active
- 2014-10-03 FI FIEP14852359.0T patent/FI3054934T3/fi active
- 2014-10-03 WO PCT/US2014/059058 patent/WO2015054063A1/en not_active Ceased
- 2014-10-03 RU RU2016109632A patent/RU2648817C2/ru active
- 2014-10-03 KR KR1020187004780A patent/KR101881791B1/ko active Active
- 2014-10-03 ES ES14852359T patent/ES2983565T3/es active Active
- 2014-10-03 US US14/505,943 patent/US20150098983A1/en not_active Abandoned
- 2014-10-03 EP EP14852359.0A patent/EP3054934B1/en active Active
- 2014-10-03 JP JP2016520591A patent/JP6231670B2/ja active Active
Also Published As
| Publication number | Publication date |
|---|---|
| ES2983565T3 (es) | 2024-10-23 |
| CN105682650A (zh) | 2016-06-15 |
| US20150098983A1 (en) | 2015-04-09 |
| KR101881791B1 (ko) | 2018-07-25 |
| CA2924190A1 (en) | 2015-04-16 |
| RU2648817C2 (ru) | 2018-03-28 |
| WO2015054063A1 (en) | 2015-04-16 |
| EP3054934B1 (en) | 2024-05-22 |
| CN105682650B (zh) | 2020-09-25 |
| BR112016006200A2 (pt) | 2017-08-01 |
| JP2016532643A (ja) | 2016-10-20 |
| TWI624278B (zh) | 2018-05-21 |
| FI3054934T3 (fi) | 2024-07-19 |
| EP3054934A1 (en) | 2016-08-17 |
| RU2016109632A (ru) | 2017-11-15 |
| KR20180021902A (ko) | 2018-03-05 |
| CA2924190C (en) | 2019-07-09 |
| EP3054934A4 (en) | 2017-04-05 |
| KR20160055934A (ko) | 2016-05-18 |
| TW201521799A (zh) | 2015-06-16 |
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