CA2973140C - Intravenous Ganaxolone Formulations and Their Use in the Treatment of Status Epilepticus and Other Epileptic Disorders - Google Patents

Intravenous Ganaxolone Formulations and Their Use in the Treatment of Status Epilepticus and Other Epileptic Disorders

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Publication number
CA2973140C
CA2973140C CA2973140A CA2973140A CA2973140C CA 2973140 C CA2973140 C CA 2973140C CA 2973140 A CA2973140 A CA 2973140A CA 2973140 A CA2973140 A CA 2973140A CA 2973140 C CA2973140 C CA 2973140C
Authority
CA
Canada
Prior art keywords
ganaxolone
formulation
cyclodextrin
sulfobutyl ether
status epilepticus
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
CA2973140A
Other languages
English (en)
French (fr)
Other versions
CA2973140A1 (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 CA2973140A1 publication Critical patent/CA2973140A1/en
Application granted granted Critical
Publication of CA2973140C publication Critical patent/CA2973140C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (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)
  • Pain & Pain Management (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Biomedical Technology (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)
CA2973140A 2015-02-06 2016-02-08 Intravenous Ganaxolone Formulations and Their Use in the Treatment of Status Epilepticus and Other Epileptic Disorders Active CA2973140C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201562112943P 2015-02-06 2015-02-06
US62/112,943 2015-02-06
PCT/US2016/016977 WO2016127170A1 (en) 2015-02-06 2016-02-08 Intravenous ganaxolone formulations and their use in treating status epilepticus and other seizure disorders

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA3254865A Division CA3254865A1 (en) 2015-02-06 2016-02-08 Intravenous ganaxolone formulations and their use in treating status epilepticus and other seizure disorders

Publications (2)

Publication Number Publication Date
CA2973140A1 CA2973140A1 (en) 2016-08-11
CA2973140C true CA2973140C (en) 2025-09-16

Family

ID=56564813

Family Applications (2)

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
CA3254865A Pending CA3254865A1 (en) 2015-02-06 2016-02-08 Intravenous ganaxolone formulations and their use in treating status epilepticus and other seizure disorders

Family Applications After (1)

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

Country Status (8)

Country Link
US (4) US20160228454A1 (enExample)
EP (2) EP4059522A1 (enExample)
JP (4) JP2018504420A (enExample)
CN (3) CN115487313A (enExample)
AU (1) AU2016214996B2 (enExample)
CA (2) CA2973140C (enExample)
IL (2) IL252848B2 (enExample)
WO (1) WO2016127170A1 (enExample)

Families Citing this family (38)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RS59734B1 (sr) 2012-01-23 2020-02-28 Sage Therapeutics Inc Formulacije neuroaktivnog steroida koje uključuju kompleks alopregnanolona i sulfobutil etar beta-ciklodekstrina
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
EP4059522A1 (en) * 2015-02-06 2022-09-21 Marinus Pharmaceuticals, Inc. Intravenous ganaxolone formulations and their use in treating status epilepticus and other seizure disorders
MA45276A (fr) * 2015-06-18 2018-04-25 Sage Therapeutics Inc Solutions de stéroïdes neuroactifs et leurs méthodes d'utilisation
EA036155B1 (ru) 2015-10-16 2020-10-06 Маринус Фармасьютикалс, Инк. Инъекционные составы нейростероида, содержащие наночастицы
WO2017112701A1 (en) 2015-12-22 2017-06-29 Zogenix International Limited Metabolism resistant fenfluramine analogs and methods of using the same
HRP20250898T1 (hr) 2015-12-22 2025-09-26 Zogenix International Limited Pripravci fenfluramina i postupci njihove pripreme
AU2017229656B2 (en) 2016-03-08 2022-09-29 Sage Therapeutics, Inc. Neuroactive steroids, compositions, and uses thereof
MX2019001669A (es) 2016-08-11 2019-09-27 Ovid Therapeutics Inc Metodos y composiciones para el tratamiento de trastornos epilepticos.
JP2019526544A (ja) 2016-08-24 2019-09-19 ゾゲニクス インターナショナル リミテッド 5−ht2bアゴニストの形成を阻害するための製剤およびその使用方法
US10391105B2 (en) 2016-09-09 2019-08-27 Marinus Pharmaceuticals Inc. Methods of treating certain depressive disorders and delirium tremens
BR112019007448A2 (pt) * 2016-10-14 2019-07-16 Marinus Pharmaceuticals Inc método de administrar um neuroesteróide para provocar surto- supressão eletroencefalográfica (eeg)
AU2017363598A1 (en) * 2016-11-22 2019-05-23 Ovid Therapeutics Inc. Methods of treating developmental disorders and/or seizure disorders with flupirtine
US10682317B2 (en) 2017-09-26 2020-06-16 Zogenix International Limited Ketogenic diet compatible fenfluramine formulation
US20190160078A1 (en) * 2017-11-10 2019-05-30 Marinus Pharmaceuticals, Inc. Ganaxolone for use in treating genetic epileptic disorders
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
WO2019216919A1 (en) 2018-05-11 2019-11-14 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
WO2020097045A1 (en) * 2018-11-05 2020-05-14 Ovid Therapeutics Inc. Use of gaboxadol, ganaxolone and allopregnanolone to treat movement disorders
SG11202104378SA (en) 2018-11-19 2021-05-28 Zogenix International Ltd Methods of treating rett syndrome using fenfluramine
US11266662B2 (en) 2018-12-07 2022-03-08 Marinus Pharmaceuticals, Inc. Ganaxolone for use in prophylaxis and treatment of postpartum depression
CA3122705A1 (en) * 2018-12-14 2020-06-18 Eisai R&D Management Co., Ltd. Aqueous based pharmaceutical formulations of 1,2-dihydropyridine compounds
WO2020157257A1 (en) * 2019-02-01 2020-08-06 H. Lundbeck A/S Injectable carbamazepine composition essentially free of 10-br-carbamazepine
JP7455852B2 (ja) * 2019-02-15 2024-03-26 ソール インターナショナル ディベロップメント エルティーディー. 注射可能なフェノール製剤およびその使用の方法
WO2020176276A1 (en) * 2019-02-25 2020-09-03 Zogenix International Limited A formulation for improving seizure control
US20200338090A1 (en) * 2019-04-29 2020-10-29 Marsh and Wang Medical Systems, LLC Seizure control compositions and methods of using same
US20210260074A1 (en) * 2019-04-29 2021-08-26 Marsh and Wang Medical Systems, LLC Seizure control compositions and methods of using same
MX2021013695A (es) * 2019-05-10 2022-01-26 Brii Biosciences Inc Composición farmacéutica que contiene brexanolona, ganaxolona y zuranolona y usos de esta.
EP4009982A4 (en) * 2019-08-05 2023-08-09 Marinus Pharmaceuticals, Inc. GANAXOLONE FOR USE IN TREATMENT OF STATUS EPILEPTICUS
MX2022006014A (es) 2019-12-06 2022-06-22 Marinus Pharmaceuticals Inc Ganaxolona para uso en el tratamiento del complejo de esclerosis tuberosa.
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)
WO2022109440A1 (en) * 2020-11-23 2022-05-27 Marinus Pharmaceuticals, Inc. Ganaxolone for use in treatment of super refractory status epilepticus
WO2022125408A1 (en) * 2020-12-07 2022-06-16 Marinus Pharmaceuticals, Inc Use of ganaxolone in treating an epilepsy disorder
WO2023060020A1 (en) * 2021-10-04 2023-04-13 Marinus Pharmaceuticals, Inc. Ganaxolone for use in treatment of established status epilepticus
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

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR0166088B1 (ko) 1990-01-23 1999-01-15 . 수용해도가 증가된 시클로덱스트린 유도체 및 이의 용도
US5376645A (en) 1990-01-23 1994-12-27 University Of Kansas Derivatives of cyclodextrins exhibiting enhanced aqueous solubility and the use thereof
EP1959966B1 (en) * 2005-11-28 2020-06-03 Marinus Pharmaceuticals, Inc. Ganaxolone formulations and methods for the making and use thereof
DK2525798T3 (da) * 2010-01-21 2017-11-20 Drawbridge Pharmaceuticals Pty Ltd Anæstetisk formulering
EP2887944B1 (en) * 2012-08-21 2021-10-06 Sage Therapeutics, Inc. Allopregnanolone for treating refractory status epilepticus
EP2925327B1 (en) * 2012-11-30 2024-01-10 The Regents of The University of California Allopregnanolone for treating, reducing or mitigating symptoms of post-partum depression
JOP20200195A1 (ar) * 2014-09-08 2017-06-16 Sage Therapeutics Inc سترويدات وتركيبات نشطة عصبياً، واستخداماتها
EP4059522A1 (en) * 2015-02-06 2022-09-21 Marinus Pharmaceuticals, Inc. Intravenous ganaxolone formulations and their use in treating status epilepticus and other seizure disorders
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
JP7566961B2 (ja) 2024-10-15
JP2024178469A (ja) 2024-12-24
CN107427458A (zh) 2017-12-01
JP2021155457A (ja) 2021-10-07
CN115381772A (zh) 2022-11-25
JP2023078301A (ja) 2023-06-06
EP4059522A1 (en) 2022-09-21
EP3253418A1 (en) 2017-12-13
AU2016214996A1 (en) 2017-06-29
US20250325562A1 (en) 2025-10-23
IL302203A (en) 2023-06-01
IL252848A0 (en) 2017-08-31
WO2016127170A1 (en) 2016-08-11
CA2973140A1 (en) 2016-08-11
CN115487313A (zh) 2022-12-20
JP2018504420A (ja) 2018-02-15
IL252848B1 (en) 2024-03-01
JP7273897B2 (ja) 2023-05-15
US20160228454A1 (en) 2016-08-11
CA3254865A1 (en) 2025-05-28
IL252848B2 (en) 2024-07-01
US20240016817A1 (en) 2024-01-18
US20230293549A1 (en) 2023-09-21
AU2016214996B2 (en) 2021-03-04

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