CA2924188C - Methods and compositions for managing pain comprising dexmedetomidine transdermal compositions - Google Patents

Methods and compositions for managing pain comprising dexmedetomidine transdermal compositions Download PDF

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Publication number
CA2924188C
CA2924188C CA2924188A CA2924188A CA2924188C CA 2924188 C CA2924188 C CA 2924188C CA 2924188 A CA2924188 A CA 2924188A CA 2924188 A CA2924188 A CA 2924188A CA 2924188 C CA2924188 C CA 2924188C
Authority
CA
Canada
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
CA2924188A
Other languages
English (en)
French (fr)
Other versions
CA2924188A1 (en
Inventor
Adchara Pongpeerapat
Amit Jain
Bret Berner
Jianye Wen
Jutaro Shudo
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 CA2924188A1 publication Critical patent/CA2924188A1/en
Application granted granted Critical
Publication of CA2924188C publication Critical patent/CA2924188C/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
    • A61K31/41Heterocyclic 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
    • A61K31/41641,3-Diazoles
    • A61K31/4174Arylalkylimidazoles, e.g. oxymetazolin, naphazoline, miconazole
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/70Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/70Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703Transdermal 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
    • A61K9/7038Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
    • A61K9/7046Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
    • A61K9/7053Transdermal 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/70Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703Transdermal 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
    • A61K9/7038Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
    • A61K9/7046Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
    • A61K9/7053Transdermal 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
    • A61K9/7061Polyacrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/02Drugs for disorders of the nervous system for peripheral neuropathies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/04Centrally acting analgesics, e.g. opioids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A61P29/02Non-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)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Dermatology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Neurology (AREA)
  • Pain & Pain Management (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Rheumatology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
CA2924188A 2013-10-07 2014-10-03 Methods and compositions for managing pain comprising dexmedetomidine transdermal compositions Active CA2924188C (en)

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

Publications (2)

Publication Number Publication Date
CA2924188A1 CA2924188A1 (en) 2015-04-16
CA2924188C true CA2924188C (en) 2018-12-18

Family

ID=52777129

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2924188A Active CA2924188C (en) 2013-10-07 2014-10-03 Methods and compositions for managing pain comprising dexmedetomidine transdermal compositions

Country Status (10)

Country Link
US (2) US20150098982A1 (https=)
EP (1) EP3054931B1 (https=)
JP (2) JP6188934B2 (https=)
KR (2) KR20180095733A (https=)
CN (2) CN105764495A (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
KR101948779B1 (ko) 2013-10-07 2019-05-21 테이코쿠 팔마 유에스에이, 인코포레이티드 덱스메데토미딘 경피 전달 장치 및 이의 사용 방법
US20150098982A1 (en) * 2013-10-07 2015-04-09 Teikoku Pharma Usa, Inc. Methods and Compositions for Managing Pain Comprising Dexmedetomidine Transdermal Compositions
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
CA2924236C (en) 2013-10-07 2020-01-07 Teikoku Pharma Usa, Inc. Methods and compositions for transdermal delivery of a non-sedative amount of dexmedetomidine
BR112019006955A2 (pt) * 2016-10-31 2019-07-02 Teikoku Pharma Usa Inc métodos de controle da dor usando dispositivos de distribuição transdérmica de dexmedetomidina
IL267689B2 (en) 2016-12-31 2025-05-01 Bioxcel Therapeutics Inc Use of sublingual dexmedetomidine for the treatment of agitation
BR112020026672A2 (pt) 2018-06-27 2021-03-30 Bioxcel Therapeutics, Inc. Formulações de filme contendo dexmedetomidina e métodos para produzi-las
US12472158B2 (en) 2019-02-27 2025-11-18 Vanderbilt University Methods of treating trigeminal nerve pain
EP3962478A1 (en) 2019-05-01 2022-03-09 Clexio Biosciences Ltd. Methods of treating pruritus
US20220211672A1 (en) 2019-05-01 2022-07-07 Clexio Biosciences Ltd. Methods of treating pruritus
BR112022000992A2 (pt) 2019-07-19 2022-06-14 Arx Llc Regimes de tratamento de dexmedetomidina não sedantes
CN117582424A (zh) * 2022-08-17 2024-02-23 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)

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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
CN1188189C (zh) * 1995-06-07 2005-02-09 奥瑟-麦内尔制药公司 基质层含有17-脱乙酰基诺孕酯的经皮贴片及基质的用途
MXPA01003310A (es) * 1998-10-02 2003-05-15 3M Innovative Properties Co Sistema de suministro de farmaco originados en mucosa y aplicaciones animales.
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
TWI341735B (en) * 2003-07-31 2011-05-11 Hisamitsu Pharmaceutical Co Adhesive preparations
WO2005034998A2 (en) * 2003-09-12 2005-04-21 Allergan, Inc. Methods and compositions for the treatment of pain and other alpha 2 adrenergic-mediated conditions
MX2007000480A (es) * 2004-07-15 2007-03-29 Japan Tobacco Inc Compuesto de benzamida fusionado e inhibidor de actividad de receptor de vainilloide 1.
US8383149B2 (en) * 2005-09-23 2013-02-26 Alza Corporation High enhancer-loading polyacrylate formulation for transdermal applications
US20070134310A1 (en) * 2005-09-23 2007-06-14 Nedberge Diane E Transdermal risperidone delivery system
EP2062575B1 (en) * 2006-09-11 2012-02-15 Sekisui Chemical Co., Ltd. Adhesive preparation comprising desglymidodrine
US8889173B2 (en) * 2008-04-18 2014-11-18 Warsaw Orthopedic, Inc. Alpha adrenergic receptor agonists for treatment of pain and/or inflammation
EP2286814B1 (en) * 2008-05-15 2013-10-16 Hisamitsu Pharmaceutical Co., Inc. Transdermal preparation containing palonosetron
WO2010014076A1 (en) * 2008-07-28 2010-02-04 EndogenX, Inc. Methods to treat pain using an alpha-2 adrenergic agonist and an endothelin antagonist
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US20130072532A1 (en) * 2010-01-08 2013-03-21 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
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US20130096170A1 (en) * 2011-10-14 2013-04-18 Hospira, Inc. Methods of treating pediatric patients using dexmedetomidine
US20150098982A1 (en) * 2013-10-07 2015-04-09 Teikoku Pharma Usa, Inc. Methods and Compositions for Managing Pain Comprising Dexmedetomidine Transdermal Compositions

Also Published As

Publication number Publication date
US20240245652A1 (en) 2024-07-25
JP2018008984A (ja) 2018-01-18
JP6522062B2 (ja) 2019-05-29
TWI629061B (zh) 2018-07-11
JP2016532645A (ja) 2016-10-20
EP3054931A2 (en) 2016-08-17
CN110604728A (zh) 2019-12-24
US20150098982A1 (en) 2015-04-09
WO2015054062A2 (en) 2015-04-16
TW201524506A (zh) 2015-07-01
JP6188934B2 (ja) 2017-08-30
BR112016007327A2 (pt) 2017-08-01
ES2855103T3 (es) 2021-09-23
KR101891186B1 (ko) 2018-08-24
CN105764495A (zh) 2016-07-13
EP3054931B1 (en) 2020-12-23
RU2654702C2 (ru) 2018-05-22
KR20180095733A (ko) 2018-08-27
EP3054931A4 (en) 2017-04-05
RU2016109631A (ru) 2017-11-15
KR20160062159A (ko) 2016-06-01
CA2924188A1 (en) 2015-04-16

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