CA3254865A1 - Intravenous ganaxolone formulations and their use in treating status epilepticus and other seizure disorders - Google Patents

Intravenous ganaxolone formulations and their use in treating status epilepticus and other seizure disorders

Info

Publication number
CA3254865A1
CA3254865A1 CA3254865A CA3254865A CA3254865A1 CA 3254865 A1 CA3254865 A1 CA 3254865A1 CA 3254865 A CA3254865 A CA 3254865A CA 3254865 A CA3254865 A CA 3254865A CA 3254865 A1 CA3254865 A1 CA 3254865A1
Authority
CA
Canada
Prior art keywords
ganaxolone
cyclodextrin
status epilepticus
formulation
sulfobutyl ether
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.)
Pending
Application number
CA3254865A
Other languages
English (en)
Inventor
Mingbao Zhang
Raymond C. Glowaky
Original Assignee
Marinus Pharmaceuticals 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 Marinus Pharmaceuticals Inc filed Critical Marinus Pharmaceuticals Inc
Publication of CA3254865A1 publication Critical patent/CA3254865A1/en
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/045Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/05Phenols
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • 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
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/28Steroids, e.g. cholesterol, bile acids or glycyrrhetinic acid
    • 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
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40Cyclodextrins; Derivatives 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
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/69Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
    • A61K47/6949Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
    • A61K47/6951Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes using cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/08Antiepileptics; Anticonvulsants

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
CA3254865A 2015-02-06 2016-02-08 Intravenous ganaxolone formulations and their use in treating status epilepticus and other seizure disorders Pending CA3254865A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201562112943P 2015-02-06 2015-02-06
US62/112,943 2015-02-06

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
CA2973140A Division CA2973140C (en) 2015-02-06 2016-02-08 Intravenous Ganaxolone Formulations and Their Use in the Treatment of Status Epilepticus and Other Epileptic Disorders

Publications (1)

Publication Number Publication Date
CA3254865A1 true CA3254865A1 (en) 2025-05-28

Family

ID=56564813

Family Applications (2)

Application Number Title Priority Date Filing Date
CA3254865A Pending CA3254865A1 (en) 2015-02-06 2016-02-08 Intravenous ganaxolone formulations and their use in treating status epilepticus and other seizure disorders
CA2973140A Active CA2973140C (en) 2015-02-06 2016-02-08 Intravenous Ganaxolone Formulations and Their Use in the Treatment of Status Epilepticus and Other Epileptic Disorders

Family Applications After (1)

Application Number Title Priority Date Filing Date
CA2973140A Active CA2973140C (en) 2015-02-06 2016-02-08 Intravenous Ganaxolone Formulations and Their Use in the Treatment of Status Epilepticus and Other Epileptic Disorders

Country Status (8)

Country Link
US (4) US20160228454A1 (cg-RX-API-DMAC7.html)
EP (2) EP4059522A1 (cg-RX-API-DMAC7.html)
JP (4) JP2018504420A (cg-RX-API-DMAC7.html)
CN (3) CN115381772A (cg-RX-API-DMAC7.html)
AU (1) AU2016214996B2 (cg-RX-API-DMAC7.html)
CA (2) CA3254865A1 (cg-RX-API-DMAC7.html)
IL (2) IL302203A (cg-RX-API-DMAC7.html)
WO (1) WO2016127170A1 (cg-RX-API-DMAC7.html)

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EP2887944B1 (en) 2012-08-21 2021-10-06 Sage Therapeutics, Inc. Allopregnanolone for treating refractory status epilepticus
US9549909B2 (en) 2013-05-03 2017-01-24 The Katholieke Universiteit Leuven Method for the treatment of dravet syndrome
JOP20200195A1 (ar) 2014-09-08 2017-06-16 Sage Therapeutics Inc سترويدات وتركيبات نشطة عصبياً، واستخداماتها
JP2018504420A (ja) * 2015-02-06 2018-02-15 マリナス ファーマシューティカルズ インコーポレイテッド 静注用ガナキソロン製剤ならびにてんかん重積状態および他の発作性障害の治療におけるその使用
MA45276A (fr) * 2015-06-18 2018-04-25 Sage Therapeutics Inc Solutions de stéroïdes neuroactifs et leurs méthodes d'utilisation
CA3001722A1 (en) 2015-10-16 2017-04-20 Marinus Pharmaceuticals, Inc. Injectable neurosteroid formulations containing nanoparticles
US20170174614A1 (en) 2015-12-22 2017-06-22 Zogenix International Limited Metabolism resistant fenfluramine analogs and methods of using the same
FI3800177T3 (fi) 2015-12-22 2025-04-29 Zogenix International Ltd Fenfluramiinikoostumukset ja menetelmät niiden valmistamiseksi
CA3158448A1 (en) 2016-03-08 2017-09-14 Sage Therapeutics, Inc. Neuroactive steroids, compositions, and uses thereof
EP3481387A4 (en) 2016-08-11 2020-04-08 Ovid Therapeutics Inc METHODS AND COMPOSITIONS FOR THE TREATMENT OF EPLEPTIC DISORDERS
EP4201427A1 (en) 2016-08-24 2023-06-28 Zogenix International Limited Formulation for inhibiting formation of 5-ht 2b agonists and methods of using same
US10391105B2 (en) 2016-09-09 2019-08-27 Marinus Pharmaceuticals Inc. Methods of treating certain depressive disorders and delirium tremens
WO2018071803A1 (en) * 2016-10-14 2018-04-19 Marinus Pharmaceuticals, Inc Method of administering a neurosteroid to effect electroencephalographic (eeg) burst suppression
CA3043626A1 (en) * 2016-11-22 2018-05-31 Ovid Therapeutics Inc. Methods of treating attention deficit/hyperactivity disorder with gaboxadol
US10682317B2 (en) 2017-09-26 2020-06-16 Zogenix International Limited Ketogenic diet compatible fenfluramine formulation
EA202091144A1 (ru) * 2017-11-10 2020-09-16 Маринус Фармасьютикалз, Инк. Ганаксолон для использования в лечении наследственных эпилептических заболеваний
CN108535398B (zh) * 2018-04-04 2020-03-27 福州海王福药制药有限公司 一种采用反相高效液相色谱法分离盐酸噻加宾手性对映体的方法
US11571397B2 (en) 2018-05-11 2023-02-07 Zogenix International Limited Compositions and methods for treating seizure-induced sudden death
US10517841B1 (en) 2018-06-14 2019-12-31 Zogenix International Limited Compositions and methods for treating respiratory depression with fenfluramine
EP3860595A4 (en) * 2018-11-05 2021-11-10 Ovid Therapeutics Inc. USE OF GABOXADOL, GANAXOLONE, AND ALLOPREGNANOLONE TO TREAT MOTION DISORDERS
CA3117868A1 (en) 2018-11-19 2020-05-28 Zogenix International Limited Methods of treating rett syndrome using fenfluramine
WO2020118142A1 (en) 2018-12-07 2020-06-11 Marinus Pharmaceuticals, Inc. Ganaxolone for use in prophylaxis and treatment of pospartum depression
MA54460A (fr) 2018-12-14 2021-10-20 Eisai R&D Man Co Ltd Formulations pharmaceutiques à base d'eau de composés de 1,2-dihydropyridine
WO2020157257A1 (en) * 2019-02-01 2020-08-06 H. Lundbeck A/S Injectable carbamazepine composition essentially free of 10-br-carbamazepine
US10959962B2 (en) * 2019-02-15 2021-03-30 Saol International Development Ltd. Injectable phenol formulations and methods of their use
JP2022521446A (ja) * 2019-02-25 2022-04-07 ゾゲニクス インターナショナル リミテッド 発作制御を改善するための製剤
US20210260074A1 (en) * 2019-04-29 2021-08-26 Marsh and Wang Medical Systems, LLC Seizure control compositions and methods of using same
US20200338090A1 (en) * 2019-04-29 2020-10-29 Marsh and Wang Medical Systems, LLC Seizure control compositions and methods of using same
KR20220006565A (ko) 2019-05-10 2022-01-17 브리 바이오사이언시스, 인크. 브렉사놀론, 가낙솔론, 또는 주라놀론을 함유하는 약제 조성물, 및 이것의 용도
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CN119950517A (zh) 2019-12-06 2025-05-09 马瑞纳斯制药公司 用于治疗结节性硬化症的加奈索酮
US11612574B2 (en) 2020-07-17 2023-03-28 Zogenix International Limited Method of treating patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
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EP4255438A4 (en) * 2020-12-07 2024-10-16 Marinus Pharmaceuticals, Inc. USE OF GANAXOLONE IN THE TREATMENT OF AN EPILEPTIC DISORDER
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CN114272216B (zh) * 2021-10-11 2023-07-04 浙江歌文达生物医药科技有限公司 一种2-氧代-1-吡咯烷衍生物的冻干制剂及其制备
CN116769070B (zh) * 2023-06-07 2025-07-01 浙江工业大学 一种功能化磁性纳米颗粒及作为手性萃取剂在液-液萃取拆分手性化合物中的应用

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JOP20200195A1 (ar) * 2014-09-08 2017-06-16 Sage Therapeutics Inc سترويدات وتركيبات نشطة عصبياً، واستخداماتها
JP2018504420A (ja) * 2015-02-06 2018-02-15 マリナス ファーマシューティカルズ インコーポレイテッド 静注用ガナキソロン製剤ならびにてんかん重積状態および他の発作性障害の治療におけるその使用
US10391105B2 (en) * 2016-09-09 2019-08-27 Marinus Pharmaceuticals Inc. Methods of treating certain depressive disorders and delirium tremens

Also Published As

Publication number Publication date
CN115381772A (zh) 2022-11-25
CA2973140A1 (en) 2016-08-11
IL252848B2 (en) 2024-07-01
US20160228454A1 (en) 2016-08-11
CA2973140C (en) 2025-09-16
IL252848B1 (en) 2024-03-01
JP2021155457A (ja) 2021-10-07
JP2024178469A (ja) 2024-12-24
US20240016817A1 (en) 2024-01-18
IL252848A0 (en) 2017-08-31
CN107427458A (zh) 2017-12-01
WO2016127170A1 (en) 2016-08-11
AU2016214996A1 (en) 2017-06-29
JP7273897B2 (ja) 2023-05-15
US20250325562A1 (en) 2025-10-23
JP7566961B2 (ja) 2024-10-15
CN115487313A (zh) 2022-12-20
US20230293549A1 (en) 2023-09-21
EP3253418A1 (en) 2017-12-13
AU2016214996B2 (en) 2021-03-04
JP2023078301A (ja) 2023-06-06
EP4059522A1 (en) 2022-09-21
IL302203A (en) 2023-06-01
JP2018504420A (ja) 2018-02-15

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