JP6188934B2 - デクスメデトミジン経皮組成物を含む疼痛管理用方法及び組成物 - Google Patents

デクスメデトミジン経皮組成物を含む疼痛管理用方法及び組成物 Download PDF

Info

Publication number
JP6188934B2
JP6188934B2 JP2016520593A JP2016520593A JP6188934B2 JP 6188934 B2 JP6188934 B2 JP 6188934B2 JP 2016520593 A JP2016520593 A JP 2016520593A JP 2016520593 A JP2016520593 A JP 2016520593A JP 6188934 B2 JP6188934 B2 JP 6188934B2
Authority
JP
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.)
Active
Application number
JP2016520593A
Other languages
English (en)
Japanese (ja)
Other versions
JP2016532645A (ja
JP2016532645A5 (https=
Inventor
ポンピーラパット，アドチャラ
ジェイン，アミット
バーナー，ブレット
ウェン，チャンイェー
シュドウ，ジュタロウ
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.)
Teikoku Pharma USA Inc
Original Assignee
Teikoku Pharma USA Inc
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 Teikoku Pharma USA Inc filed Critical Teikoku Pharma USA Inc
Publication of JP2016532645A publication Critical patent/JP2016532645A/ja
Publication of JP2016532645A5 publication Critical patent/JP2016532645A5/ja
Application granted granted Critical
Publication of JP6188934B2 publication Critical patent/JP6188934B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • 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
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • 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
    • 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
    • A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
    • 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
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A61P29/02—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] without antiinflammatory effect

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Dermatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Pain & Pain Management (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Rheumatology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
JP2016520593A 2013-10-07 2014-10-03 デクスメデトミジン経皮組成物を含む疼痛管理用方法及び組成物 Active JP6188934B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201361887870P 2013-10-07 2013-10-07
US61/887,870 2013-10-07
PCT/US2014/059057 WO2015054062A2 (en) 2013-10-07 2014-10-03 Methods and compositions for managing pain comprising dexmedetomidine transdermal compositions

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2017146472A Division JP6522062B2 (ja) 2013-10-07 2017-07-28 デクスメデトミジン経皮組成物を含む疼痛管理用方法及び組成物

Publications (3)

Publication Number Publication Date
JP2016532645A JP2016532645A (ja) 2016-10-20
JP2016532645A5 JP2016532645A5 (https=) 2017-07-06
JP6188934B2 true JP6188934B2 (ja) 2017-08-30

Family

ID=52777129

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2016520593A Active JP6188934B2 (ja) 2013-10-07 2014-10-03 デクスメデトミジン経皮組成物を含む疼痛管理用方法及び組成物
JP2017146472A Active JP6522062B2 (ja) 2013-10-07 2017-07-28 デクスメデトミジン経皮組成物を含む疼痛管理用方法及び組成物

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2017146472A Active JP6522062B2 (ja) 2013-10-07 2017-07-28 デクスメデトミジン経皮組成物を含む疼痛管理用方法及び組成物

Country Status (10)

Country Link
US (2) US20150098982A1 (https=)
EP (1) EP3054931B1 (https=)
JP (2) JP6188934B2 (https=)
KR (2) KR20180095733A (https=)
CN (2) CN110604728A (https=)
CA (1) CA2924188C (https=)
ES (1) ES2855103T3 (https=)
RU (1) RU2654702C2 (https=)
TW (1) TWI629061B (https=)
WO (1) WO2015054062A2 (https=)

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101827980B1 (ko) 2013-10-07 2018-02-13 테이코쿠 팔마 유에스에이, 인코포레이티드 덱스메데토미딘 경피 전달 장치 및 이의 사용 방법
BR112016006848A2 (pt) 2013-10-07 2017-08-01 Teikoku Pharma Usa Inc métodos e composições para distribuição transdérmica de uma quantidade não sedativa de dexmedetomidina
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
EP3054931B1 (en) * 2013-10-07 2020-12-23 Teikoku Pharma USA, Inc. Transdermal delivery device for managing pain comprising dexmedetomidine transdermal compositions
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
PL3813802T3 (pl) 2018-06-27 2025-04-22 Bioxcel Therapeutics, Inc. Formulacje błony zawierające deksmedetomidynę i sposoby ich wytwarzania
US12472158B2 (en) 2019-02-27 2025-11-18 Vanderbilt University Methods of treating trigeminal nerve pain
WO2020222192A1 (en) 2019-05-01 2020-11-05 Clexio Biosciences Ltd. Methods of treating pruritus
EP3962478A1 (en) 2019-05-01 2022-03-09 Clexio Biosciences Ltd. Methods of treating pruritus
EP3999058A4 (en) 2019-07-19 2023-05-03 Bioxcel Therapeutics, Inc. NON-SEDATIVE DEXMEDETOMIDINE-BASED TREATMENT REGIMEN
WO2024037545A1 (zh) * 2022-08-17 2024-02-22 宜昌人福药业有限责任公司 右美托咪定经皮组合物、透皮贴剂及其制备方法和应用
US11806334B1 (en) 2023-01-12 2023-11-07 Bioxcel Therapeutics, Inc. Non-sedating dexmedetomidine treatment regimens

Family Cites Families (22)

* Cited by examiner, † Cited by third party
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
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
GB2290964A (en) * 1994-07-08 1996-01-17 Arto Olavi Urtti Transdermal drug delivery system
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
NZ510771A (en) * 1998-10-02 2003-08-29 3M Innovative Properties Co Mucosal originated drug delivery systems
US7635488B2 (en) * 2001-03-13 2009-12-22 Dbv Technologies Patches and uses thereof
KR100511492B1 (ko) * 2002-10-11 2005-08-31 주식회사 태평양 에페리손, 톨페리손 또는 그것들의 염을 포함하는경피흡수제제
JP4694967B2 (ja) * 2003-07-31 2011-06-08 久光製薬株式会社 貼付剤
MXPA06002716A (es) * 2003-09-12 2006-06-06 Allergan Inc Metodos y composiciones para el tratamiento de dolor y otras condiciones mediadas por adrenergicos de alfa-2.
KR101042490B1 (ko) * 2004-07-15 2011-06-16 니뽄 다바코 산교 가부시키가이샤 축합 벤즈아미드 화합물 및 바닐로이드 수용체 1형(ｖｒ1)활성 저해제
US20070134310A1 (en) * 2005-09-23 2007-06-14 Nedberge Diane E Transdermal risperidone delivery system
EP2308480B1 (en) * 2005-09-23 2014-08-13 ALZA Corporation High Enhancer-Loading Polyacrylate Formulation for Transdermal Applications
US20090258063A1 (en) * 2006-09-11 2009-10-15 Sekisui Chemical Co., Ltd. Transdermal patch
US8889173B2 (en) * 2008-04-18 2014-11-18 Warsaw Orthopedic, Inc. Alpha adrenergic receptor agonists for treatment of pain and/or inflammation
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
EP2330903A4 (en) * 2008-07-28 2011-10-12 Endogenx Inc METHOD FOR TREATING PAIN USING AN ALPHA-2 ADRENEER AGONIST AND AN ENDOTHELINE ANTAGONIST
US9308203B2 (en) * 2008-10-01 2016-04-12 Taiwan Biotech Co., Ltd. Pressure sensitive adhesive matrix device or system for the treatment or prevention of onychomycosis or tinea pedis
AU2011204315A1 (en) * 2010-01-08 2012-08-02 Recro Pharma, Inc. Topical transdermal dexmedetomidine compositions and methods of use thereof
US8563031B2 (en) * 2010-05-27 2013-10-22 Absize, Inc. Piroxicam-containing matrix patches and methods for the topical treatment of acute and chronic pain and inflammation therewith
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
US20130096170A1 (en) * 2011-10-14 2013-04-18 Hospira, Inc. Methods of treating pediatric patients using dexmedetomidine
EP3054931B1 (en) * 2013-10-07 2020-12-23 Teikoku Pharma USA, Inc. Transdermal delivery device for managing pain comprising dexmedetomidine transdermal compositions

Also Published As

Publication number Publication date
CA2924188C (en) 2018-12-18
EP3054931A2 (en) 2016-08-17
US20240245652A1 (en) 2024-07-25
JP2018008984A (ja) 2018-01-18
EP3054931A4 (en) 2017-04-05
ES2855103T3 (es) 2021-09-23
RU2654702C2 (ru) 2018-05-22
TW201524506A (zh) 2015-07-01
RU2016109631A (ru) 2017-11-15
KR20180095733A (ko) 2018-08-27
BR112016007327A2 (pt) 2017-08-01
CN105764495A (zh) 2016-07-13
EP3054931B1 (en) 2020-12-23
TWI629061B (zh) 2018-07-11
JP6522062B2 (ja) 2019-05-29
KR101891186B1 (ko) 2018-08-24
JP2016532645A (ja) 2016-10-20
KR20160062159A (ko) 2016-06-01
CN110604728A (zh) 2019-12-24
WO2015054062A2 (en) 2015-04-16
CA2924188A1 (en) 2015-04-16
US20150098982A1 (en) 2015-04-09

Similar Documents

Publication Publication Date Title
JP6188934B2 (ja) デクスメデトミジン経皮組成物を含む疼痛管理用方法及び組成物
JP6494818B2 (ja) デクスメデトミジン経皮組成物を用いる、注意欠陥多動性障害、不安症及び不眠症の治療法及び組成物
US10772871B2 (en) Dexmedetomidine transdermal delivery devices and methods for using the same
JP6188933B2 (ja) 非鎮静量のデクスメデトミジンの経皮送達用方法及び組成物
JP6208859B6 (ja) デクスメデトミジン経皮送達デバイス及びその使用法
HK40018815A (en) Methods and compositions for managing pain comprising dexmedetomidine transdermal compositions
HK40018790A (en) Dexmedetomidine transdermal delivery devices and methods for using the same
BR112016007327B1 (pt) Uso de dispositivo de distribuição transdérmica para controlar dor

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20160601

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20160601

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20170224

A524 Written submission of copy of amendment under article 19 pct

Free format text: JAPANESE INTERMEDIATE CODE: A524

Effective date: 20170524

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20170703

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20170801

R150 Certificate of patent or registration of utility model

Ref document number: 6188934

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250