AU2018278332B2 - Methods and compositions for treating excessive sleepiness - Google Patents

Methods and compositions for treating excessive sleepiness Download PDF

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Publication number
AU2018278332B2
AU2018278332B2 AU2018278332A AU2018278332A AU2018278332B2 AU 2018278332 B2 AU2018278332 B2 AU 2018278332B2 AU 2018278332 A AU2018278332 A AU 2018278332A AU 2018278332 A AU2018278332 A AU 2018278332A AU 2018278332 B2 AU2018278332 B2 AU 2018278332B2
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apc
dose
daily dose
once
dosing regimen
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AU2018278332A1 (en
Inventor
Lawrence Patrick CARTER
Yuan Lu
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Jazz Pharmaceuticals Ireland Ltd
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Jazz Pharmaceuticals Ireland Ltd
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Publication of AU2018278332A1 publication Critical patent/AU2018278332A1/en
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    • 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
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/27—Esters, e.g. nitroglycerine, selenocyanates of carbamic or thiocarbamic acids, meprobamate, carbachol, neostigmine
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • 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
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material 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)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Emergency Medicine (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
AU2018278332A 2017-06-02 2018-06-01 Methods and compositions for treating excessive sleepiness Active AU2018278332B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201762514176P 2017-06-02 2017-06-02
US62/514,176 2017-06-02
PCT/US2018/035532 WO2018222954A1 (en) 2017-06-02 2018-06-01 Methods and compositions for treating excessive sleepiness

Publications (2)

Publication Number Publication Date
AU2018278332A1 AU2018278332A1 (en) 2020-01-30
AU2018278332B2 true AU2018278332B2 (en) 2022-05-19

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ID=64455104

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2018278332A Active AU2018278332B2 (en) 2017-06-02 2018-06-01 Methods and compositions for treating excessive sleepiness

Country Status (12)

Country Link
US (7) US10959976B2 (enExample)
EP (1) EP3630072A4 (enExample)
JP (1) JP2020528075A (enExample)
KR (3) KR20200016889A (enExample)
CN (1) CN111201014A (enExample)
AU (1) AU2018278332B2 (enExample)
BR (1) BR112019025286A2 (enExample)
CA (1) CA3065522A1 (enExample)
MX (1) MX390786B (enExample)
MY (1) MY203401A (enExample)
PH (1) PH12019502723A1 (enExample)
WO (1) WO2018222954A1 (enExample)

Families Citing this family (27)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11602513B1 (en) 2016-07-22 2023-03-14 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US12186296B1 (en) 2016-07-22 2025-01-07 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11986451B1 (en) 2016-07-22 2024-05-21 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11602512B1 (en) 2016-07-22 2023-03-14 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US12478604B1 (en) 2016-07-22 2025-11-25 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11504347B1 (en) 2016-07-22 2022-11-22 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
UY37341A (es) 2016-07-22 2017-11-30 Flamel Ireland Ltd Formulaciones de gamma-hidroxibutirato de liberación modificada con farmacocinética mejorada
US10195151B2 (en) 2016-09-06 2019-02-05 Jazz Pharmaceuticals International Iii Limited Formulations of (R)-2-amino-3-phenylpropyl carbamate
EP3630072A4 (en) 2017-06-02 2021-03-10 Jazz Pharmaceuticals Ireland Limited METHODS AND COMPOSITIONS FOR TREATMENT OF EXCESSIVE Drowsiness
JP7553453B2 (ja) 2019-03-01 2024-09-18 フラメル アイルランド リミテッド 食事摂取状態における改善された薬物動態を有するガンマ－ヒドロキシ酪酸塩組成物
WO2021001457A1 (en) * 2019-07-04 2021-01-07 Sandoz Ag Crystalline (r)-2-amino-3-phenylpropylcarbamate acid addition salts
US10940133B1 (en) 2020-03-19 2021-03-09 Jazz Pharmaceuticals Ireland Limited Methods of providing solriamfetol therapy to subjects with impaired renal function
US20240358668A1 (en) * 2021-09-03 2024-10-31 Axsome Therapeutics, Inc. Methods and compisitions for ameliorating biomarkers associated with cardiovascualr risk using (r)-2-amino-3-phenylpropyl carbamate
US11583510B1 (en) 2022-02-07 2023-02-21 Flamel Ireland Limited Methods of administering gamma hydroxybutyrate formulations after a high-fat meal
US11779557B1 (en) 2022-02-07 2023-10-10 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
AU2023375326A1 (en) * 2022-11-07 2025-05-22 Axsome Therapeutics Compositions and methods for treating insomnia
EP4626417A1 (en) * 2022-11-30 2025-10-08 Axsome Therapeutics Methods and compositions for improving driving performance
US11771666B1 (en) 2022-12-30 2023-10-03 Axsome Malta Ltd. Methods of administering solriamfetol to lactating women
US12005036B1 (en) 2022-12-30 2024-06-11 Axsome Malta Ltd. Methods of administering solriamfetol to lactating women
CN120641090A (zh) * 2022-12-30 2025-09-12 阿克苏姆马耳他有限公司 向哺乳期女性施用索安非托的方法
US12102609B2 (en) 2022-12-30 2024-10-01 Axsome Malta Ltd. Methods of administering solriamfetol to lactating women
US12036194B1 (en) 2022-12-30 2024-07-16 Axsome Malta Ltd. Methods of administering solriamfetol to lactating women
US12064411B1 (en) * 2022-12-30 2024-08-20 Axsome Malta Ltd. Methods of administering solriamfetol to lactating women
US12090126B2 (en) 2022-12-30 2024-09-17 Axsome Malta Ltd. Methods of administering solriamfetol to lactating women
AU2024278948A1 (en) * 2023-05-30 2025-12-11 Axsome Therapeutics, Inc. Solriamfetol for treating cognitive impairment in a subject with impaired cognition associated with obstructive sleep apnea and excessive daytime sleepiness
WO2025042959A1 (en) * 2023-08-21 2025-02-27 Axsome Therapeutics, Inc. Use of solriamfetol for the treatment of orphan diseases
WO2025064549A1 (en) * 2023-09-18 2025-03-27 Axsome Therapeutics, Inc. Solriamfetol for improving cognitive health in apnea patients

Family Cites Families (42)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2939660A1 (de) 1979-09-29 1981-04-16 Basf Ag, 6700 Ludwigshafen Neue carbamate, ihre herstellung und diese enthaltende pharmazeutische zubereitungen
CZ285829B6 (cs) 1993-06-10 1999-11-17 Eli Lilly And Company Použití derivátu tetrahydrobenz [c,d]indolu pro výrobu farmaceutického prostředku vhodného pro ošetřování sexuální dysfunkce
DE9311004U1 (de) 1993-07-23 1993-10-14 Mauser-Werke GmbH, 50321 Brühl Palettencontainer
KR100197892B1 (ko) 1994-09-09 1999-06-15 남창우 신규한 페닐알킬아미노 카바메이트 화합물과 그의 제조방법
US5756817C1 (en) 1995-02-11 2001-04-17 Sk Corp O-carbamoyl-phenylananinol compounds their pharmaceutically useful salts and process for preparing the same
KR0173862B1 (ko) 1995-02-11 1999-04-01 조규향 O-카바모일-(d)-페닐알라닌올 화합물과 그의 약제학적으로 유용한 염 및 이들의 제조방법
KR0173863B1 (ko) 1995-04-10 1999-04-01 조규향 페닐에 치환체가 있는 o-카바모일-페닐알라닌올 화합물과 그의 약제학적으로 유용한 염 및 이들의 제조방법
ES2170878T3 (es) 1996-10-10 2002-08-16 Sk Corp Compuestos de o-carbamoil-fenilalaninol y sus sales farmaceuticamente utiles.
WO1998017636A1 (en) 1996-10-22 1998-04-30 Ortho Pharmaceutical Corporation Phenylalaninol derivatives for the treatment of central nervous system disorders
CA2355293C (en) 1998-12-23 2005-08-16 Orphan Medical, Inc. Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
US6680322B2 (en) 1999-12-02 2004-01-20 Osi Pharmaceuticals, Inc. Compounds specific to adenosine A1 receptors and uses thereof
US6680324B2 (en) 2000-12-01 2004-01-20 Osi Pharmaceuticals, Inc. Compounds specific to adenosine A1 receptors and uses thereof
WO2002067921A1 (en) 2001-02-27 2002-09-06 Ortho-Mcneil Pharmaceutical, Inc. Carbamate compounds for use in preventing or treating bipolar disorder
WO2002067926A1 (en) 2001-02-27 2002-09-06 Ortho-Mcneil Pharmaceutical, Inc. Carbamate compounds for use in preventing or treating movement disorders
DK1399144T3 (da) 2001-02-27 2006-07-24 Ortho Mcneil Pharm Inc Carbamatforbindelser til anvendelse ved forebyggelse eller behandling af angstforstyrrelser
US6680299B2 (en) 2001-07-27 2004-01-20 Enanta Pharmaceuticals, Inc. 4'-substituted leucomycins
EP1534238A1 (en) 2002-07-29 2005-06-01 ALZA Corporation Formulations and dosage forms for controlled delivery of topiramate
US20050080268A1 (en) 2003-10-08 2005-04-14 Yong-Moon Choi Process of preparing O-carbamoyl compounds in the presence of active amine group
US20050203130A1 (en) 2003-12-02 2005-09-15 Erik Buntinx Use of D4 and 5-HT2A antagonists, inverse agonists or partial agonists
CN101132787A (zh) 2004-10-28 2008-02-27 Sk株式会社 抑郁的辅助疗法
CN101217949B (zh) 2005-06-08 2012-10-17 爱思开生物制药株式会社 治疗睡眠-清醒病症
DE602006012670D1 (de) 2005-06-22 2010-04-15 Sk Holdings Co Ltd Behandlung der sexuellen dysfunktion
JP5094720B2 (ja) 2005-07-26 2012-12-12 ジヤンセン・フアーマシユーチカ・ナームローゼ・フエンノートシヤツプ サブスタンス関連障害を処置する方法
CA2673487A1 (en) 2006-10-13 2008-04-24 Janssen Pharmaceutica Nv Phenylalkylamino carbamate compositions
US8778398B2 (en) 2008-11-04 2014-07-15 Jazz Pharmaceuticals, Inc. Immediate release formulations and dosage forms of gamma-hydroxybutyrate
US8771735B2 (en) 2008-11-04 2014-07-08 Jazz Pharmaceuticals, Inc. Immediate release dosage forms of sodium oxybate
CA2765463C (en) 2009-06-22 2018-10-09 Moise A. Khayrallah Methods for treating or preventing fatigue
US8232315B2 (en) 2009-06-26 2012-07-31 Sk Biopharmaceuticals Co., Ltd. Methods for treating drug addiction and improving addiction-related behavior
ES2743153T3 (es) 2009-11-06 2020-02-18 Sk Biopharmaceuticals Co Ltd Métodos para tratar el síndrome de fibromialgia
RU2556585C2 (ru) 2009-11-06 2015-07-10 Ск Биофармасъютиклс Ко., Лтд. Способы лечения синдрома дефицита внимания и гиперактивности
WO2011139271A1 (en) 2010-05-04 2011-11-10 Jazz Pharmaceuticals, Inc. Immediate release formulations and dosage forms of gamma-hydroxybutyrate
EP2392325A1 (en) 2010-06-04 2011-12-07 Universitätsklinikum Münster Compounds for the prevention and/or treatment of osteoarthrosis
US9610274B2 (en) 2010-06-30 2017-04-04 Sk Biopharmaceuticals Co., Ltd. Methods for treating bipolar disorder
US8623913B2 (en) 2010-06-30 2014-01-07 Sk Biopharmaceuticals Co., Ltd. Methods for treating restless legs syndrome
US9050302B2 (en) 2013-03-01 2015-06-09 Jazz Pharmaceuticals Ireland Limited Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
DK2968208T3 (da) 2013-03-13 2022-08-22 Jazz Pharmaceuticals Ireland Ltd Behandling af kataplexi
WO2015006685A1 (en) 2013-07-12 2015-01-15 Jazz Pharmaceuticals International Iii Limited Promotion of smoking cessation
TW201919605A (zh) 2013-07-18 2019-06-01 南韓商愛思開生物製藥股份有限公司 肥胖之治療
TWI698415B (zh) 2014-02-28 2020-07-11 南韓商愛思開生物製藥股份有限公司 胺基羰基胺基甲酸酯化合物
US10195151B2 (en) 2016-09-06 2019-02-05 Jazz Pharmaceuticals International Iii Limited Formulations of (R)-2-amino-3-phenylpropyl carbamate
EP3630072A4 (en) 2017-06-02 2021-03-10 Jazz Pharmaceuticals Ireland Limited METHODS AND COMPOSITIONS FOR TREATMENT OF EXCESSIVE Drowsiness
US10940133B1 (en) 2020-03-19 2021-03-09 Jazz Pharmaceuticals Ireland Limited Methods of providing solriamfetol therapy to subjects with impaired renal function

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
BOGAN R.K. et al., "Effect of oral JZP-110 (ADX-N05) treatment on wakefulness and sleepiness in adults with narcolepsy", Sleep Med., (2015-09), vol. 16, no. 9, pages 1102 - 1108 *
CHAD RUOFF ET AL, "Effect of Oral JZP-110 (ADX-N05) on Wakefulness and Sleepiness in Adults with Narcolepsy: A Phase 2b Study", SLEEP, US, (2016-07-01), vol. 39, no. 7, doi:10.5665/sleep.5968, ISSN 0161-8105, pages 1379 - 1387 *
STROLLO P J ET AL, Sleep (2017), vol. 40, no. Suppl. 1, doi:10.1093/SLEEPJ/ZSX050.643,, page A238 *
THORPY M J ET AL, "A randomized, placebo-controlled, phase 3 study of the safety and efficacy of solriamfetol (JZP-110) for the treatment of excessive sleepiness in patients with narcolepsy", SLEEP MEDICINE (2017), vol. 40, page e327 *

Also Published As

Publication number Publication date
BR112019025286A2 (pt) 2020-06-23
US10912754B2 (en) 2021-02-09
JP2020528075A (ja) 2020-09-17
EP3630072A1 (en) 2020-04-08
PH12019502723A1 (en) 2020-07-13
US10959976B2 (en) 2021-03-30
CN111201014A (zh) 2020-05-26
US20250114322A1 (en) 2025-04-10
MY203401A (en) 2024-06-26
US20210205257A1 (en) 2021-07-08
WO2018222954A1 (en) 2018-12-06
US20240189270A1 (en) 2024-06-13
CA3065522A1 (en) 2018-12-06
EP3630072A4 (en) 2021-03-10
US20200281886A1 (en) 2020-09-10
US11648232B2 (en) 2023-05-16
KR20200016889A (ko) 2020-02-17
AU2018278332A1 (en) 2020-01-30
MX2019014409A (es) 2022-03-17
US20200163927A1 (en) 2020-05-28
KR20230145525A (ko) 2023-10-17
KR20240162165A (ko) 2024-11-14
US11865098B1 (en) 2024-01-09
MX390786B (es) 2025-03-21
US20240033243A1 (en) 2024-02-01
NZ760594A (en) 2025-05-02
KR102726728B1 (ko) 2024-11-05
US20240180866A1 (en) 2024-06-06

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