IL252848B2 - Intravenous Genaxolone Formulations and Their Use in the Treatment of Epileptic Seizures and Other Seizure Disorders - Google Patents

Intravenous Genaxolone Formulations and Their Use in the Treatment of Epileptic Seizures and Other Seizure Disorders

Info

Publication number
IL252848B2
IL252848B2 IL252848A IL25284817A IL252848B2 IL 252848 B2 IL252848 B2 IL 252848B2 IL 252848 A IL252848 A IL 252848A IL 25284817 A IL25284817 A IL 25284817A IL 252848 B2 IL252848 B2 IL 252848B2
Authority
IL
Israel
Prior art keywords
ganaxolone
cyclodextrin
formulation
captisol
sulfobutyl ether
Prior art date
Application number
IL252848A
Other languages
English (en)
Hebrew (he)
Other versions
IL252848A0 (en
IL252848B1 (en
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 IL252848A0 publication Critical patent/IL252848A0/en
Publication of IL252848B1 publication Critical patent/IL252848B1/en
Publication of IL252848B2 publication Critical patent/IL252848B2/en

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)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (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)
IL252848A 2015-02-06 2016-02-08 Intravenous Genaxolone Formulations and Their Use in the Treatment of Epileptic Seizures and Other Seizure Disorders IL252848B2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201562112943P 2015-02-06 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

Publications (3)

Publication Number Publication Date
IL252848A0 IL252848A0 (en) 2017-08-31
IL252848B1 IL252848B1 (en) 2024-03-01
IL252848B2 true IL252848B2 (en) 2024-07-01

Family

ID=56564813

Family Applications (2)

Application Number Title Priority Date Filing Date
IL252848A IL252848B2 (en) 2015-02-06 2016-02-08 Intravenous Genaxolone Formulations and Their Use in the Treatment of Epileptic Seizures and Other Seizure Disorders
IL302203A IL302203A (en) 2015-02-06 2016-02-08 Intravenous Genaxolone formulations and their use in the treatment of epileptic seizures and other convulsive disorders

Family Applications After (1)

Application Number Title Priority Date Filing Date
IL302203A IL302203A (en) 2015-02-06 2016-02-08 Intravenous Genaxolone formulations and their use in the treatment of epileptic seizures and other convulsive disorders

Country Status (8)

Country Link
US (4) US20160228454A1 (https=)
EP (2) EP4059522A1 (https=)
JP (4) JP2018504420A (https=)
CN (3) CN115381772A (https=)
AU (1) AU2016214996B2 (https=)
CA (2) CA2973140C (https=)
IL (2) IL252848B2 (https=)
WO (1) WO2016127170A1 (https=)

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EP2806877B2 (en) 2012-01-23 2025-01-29 Sage Therapeutics, Inc. Neuroactive steroid formulations comprising a complex of allopregnanolone and sulfobutyl ether beta-cyclodextrin
CA2882708A1 (en) 2012-08-21 2014-02-27 Sage Therapeutics, Inc. Methods of treating epilepsy or 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
CA2973140C (en) * 2015-02-06 2025-09-16 Marinus Pharmaceuticals, Inc. Intravenous Ganaxolone Formulations and Their Use in the Treatment of Status Epilepticus and Other Epileptic Disorders
AR105044A1 (es) * 2015-06-18 2017-08-30 Sage Therapeutics Inc Soluciones de esteroides neuroactivos y sus métodos de uso, recipiente
AU2016338672A1 (en) 2015-10-16 2018-04-12 Marinus Pharmaceuticals, Inc. Injectable neurosteroid formulations containing nanoparticles
WO2017112701A1 (en) 2015-12-22 2017-06-29 Zogenix International Limited Metabolism resistant fenfluramine analogs and methods of using the same
ES3024232T3 (en) 2015-12-22 2025-06-04 Zogenix International Ltd Fenfluramine compositions and methods of preparing the same
KR20240157128A (ko) 2016-03-08 2024-10-31 세이지 테라퓨틱스, 인크. 신경활성 스테로이드, 조성물, 및 그의 용도
EP3481387A4 (en) 2016-08-11 2020-04-08 Ovid Therapeutics Inc METHOD AND COMPOSITIONS FOR TREATING EPILEPTIC DISEASES
SG11201900975XA (en) 2016-08-24 2019-03-28 Zogenix International Ltd 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
CA3039981A1 (en) * 2016-10-14 2018-04-19 Marinus Pharmaceuticals, Inc Method of administering a neurosteroid to effect electroencephalographic (eeg) burst suppression
CN110225754A (zh) * 2016-11-22 2019-09-10 奥维德医疗公司 用氟吡汀治疗发育障碍和/或癫痫发作紊乱的方法
US10682317B2 (en) 2017-09-26 2020-06-16 Zogenix International Limited Ketogenic diet compatible fenfluramine formulation
MY204493A (en) * 2017-11-10 2024-08-30 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
EP3806835A1 (en) 2018-06-14 2021-04-21 Zogenix International Limited Compositions and methods for treating respiratory depression with fenfluramine
JP2022511673A (ja) * 2018-11-05 2022-02-01 オービッド・セラピューティクス・インコーポレイテッド 運動障害を処置するためのガボキサドール、ガナキソロンおよびアロプレグナノロンの使用
EA202191079A1 (ru) 2018-11-19 2021-09-20 Зодженикс Интернэшнл Лимитед Способы лечения синдрома ретта с применением фенфлурамина
US11266662B2 (en) 2018-12-07 2022-03-08 Marinus Pharmaceuticals, Inc. Ganaxolone for use in prophylaxis and treatment of postpartum 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
US11529357B2 (en) * 2019-02-01 2022-12-20 H. Lundbeck A/S Injectable carbamazepine composition essentially free of 10-bromo-carbamazepine
EP3923916A4 (en) * 2019-02-15 2022-12-21 Saol International Development Ltd. INJECTABLE PHENOL FORMULATIONS AND METHODS OF USE
EP3930841A4 (en) * 2019-02-25 2022-11-30 Zogenix International Limited FORMULATION TO IMPROVE 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.
JP7754799B2 (ja) * 2019-08-05 2025-10-15 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 てんかん重積状態の治療に使用するためのガナキソロン
WO2021113834A1 (en) 2019-12-06 2021-06-10 Marinus Pharmaceuticals, Inc. Ganaxolone for use in treating tuberous sclerosis complex
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
EP4255438A4 (en) * 2020-12-07 2024-10-16 Marinus Pharmaceuticals, Inc. USE OF GANAXOLONE IN THE TREATMENT OF AN EPILEPTIC 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

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WO2011088503A1 (en) * 2010-01-21 2011-07-28 Goodchild Investments Pty Ltd Anaesthetic formulation
US8022054B2 (en) * 2005-11-28 2011-09-20 Marinus Pharmaceuticals Liquid ganaxolone formulations and methods for the making and use thereof
WO2014085668A1 (en) * 2012-11-30 2014-06-05 The Regents Of The University Of California Anticonvulsant activity of steroids

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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
CA2882708A1 (en) * 2012-08-21 2014-02-27 Sage Therapeutics, Inc. Methods of treating epilepsy or status epilepticus
JOP20200195A1 (ar) * 2014-09-08 2017-06-16 Sage Therapeutics Inc سترويدات وتركيبات نشطة عصبياً، واستخداماتها
CA2973140C (en) * 2015-02-06 2025-09-16 Marinus Pharmaceuticals, Inc. Intravenous Ganaxolone Formulations and Their Use in the Treatment of Status Epilepticus and Other Epileptic Disorders
US10391105B2 (en) * 2016-09-09 2019-08-27 Marinus Pharmaceuticals Inc. Methods of treating certain depressive disorders and delirium tremens

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8022054B2 (en) * 2005-11-28 2011-09-20 Marinus Pharmaceuticals Liquid ganaxolone formulations and methods for the making and use thereof
WO2011088503A1 (en) * 2010-01-21 2011-07-28 Goodchild Investments Pty Ltd Anaesthetic formulation
WO2014085668A1 (en) * 2012-11-30 2014-06-05 The Regents Of The University Of California Anticonvulsant activity of steroids

Also Published As

Publication number Publication date
JP2018504420A (ja) 2018-02-15
CN115487313A (zh) 2022-12-20
CA2973140C (en) 2025-09-16
JP7273897B2 (ja) 2023-05-15
JP7566961B2 (ja) 2024-10-15
EP4059522A1 (en) 2022-09-21
AU2016214996A1 (en) 2017-06-29
IL252848A0 (en) 2017-08-31
US20250325562A1 (en) 2025-10-23
US20230293549A1 (en) 2023-09-21
CN107427458A (zh) 2017-12-01
JP2021155457A (ja) 2021-10-07
EP3253418A1 (en) 2017-12-13
CN115381772A (zh) 2022-11-25
CA2973140A1 (en) 2016-08-11
JP2023078301A (ja) 2023-06-06
AU2016214996B2 (en) 2021-03-04
IL252848B1 (en) 2024-03-01
IL302203A (en) 2023-06-01
WO2016127170A1 (en) 2016-08-11
US20240016817A1 (en) 2024-01-18
JP2024178469A (ja) 2024-12-24
CA3254865A1 (en) 2025-05-28
US20160228454A1 (en) 2016-08-11

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