CA2924190C - Methods and compositions for treating withdrawal syndromes using non-sedative dexmedetomidine transdermal compositions - Google Patents

Methods and compositions for treating withdrawal syndromes using non-sedative dexmedetomidine transdermal compositions Download PDF

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Publication number
CA2924190C
CA2924190C CA2924190A CA2924190A CA2924190C CA 2924190 C CA2924190 C CA 2924190C CA 2924190 A CA2924190 A CA 2924190A CA 2924190 A CA2924190 A CA 2924190A CA 2924190 C CA2924190 C CA 2924190C
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CA
Canada
Prior art keywords
dexmedetomidine
transdermal delivery
delivery device
subject
transdermal
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CA2924190A
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English (en)
French (fr)
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CA2924190A1 (en
Inventor
Adchara Pongpeerapat
Amit Jain
Bret Berner
Jianye Wen
Jutaro Shudo
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Teikoku Pharma USA Inc
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Teikoku Pharma USA Inc
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Publication of CA2924190A1 publication Critical patent/CA2924190A1/en
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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)
CA2924190A 2013-10-07 2014-10-03 Methods and compositions for treating withdrawal syndromes using non-sedative dexmedetomidine transdermal compositions Active CA2924190C (en)

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 (2)

Publication Number Publication Date
CA2924190A1 CA2924190A1 (en) 2015-04-16
CA2924190C true CA2924190C (en) 2019-07-09

Family

ID=52777130

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2924190A Active CA2924190C (en) 2013-10-07 2014-10-03 Methods and compositions for treating withdrawal syndromes using non-sedative dexmedetomidine transdermal compositions

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)

* Cited by examiner, † Cited by third party
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)

* 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
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

Also Published As

Publication number Publication date
ES2983565T3 (es) 2024-10-23
JP6231670B2 (ja) 2017-11-15
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
EP3054934A4 (en) 2017-04-05
KR20160055934A (ko) 2016-05-18
TW201521799A (zh) 2015-06-16

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