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

Methods and compositions for treating excessive sleepiness Download PDF

Info

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
Authority
AU
Australia
Prior art keywords
apc
dose
daily dose
once
dosing regimen
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
AU2018278332A
Other languages
English (en)
Other versions
AU2018278332A1 (en
Inventor
Lawrence Patrick CARTER
Yuan Lu
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Jazz Pharmaceuticals Ireland Ltd
Original Assignee
Jazz Pharmaceuticals Ireland Ltd
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=64455104&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AU2018278332(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Jazz Pharmaceuticals Ireland Ltd filed Critical Jazz Pharmaceuticals Ireland Ltd
Publication of AU2018278332A1 publication Critical patent/AU2018278332A1/en
Application granted granted Critical
Publication of AU2018278332B2 publication Critical patent/AU2018278332B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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
    • A61K31/21—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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Emergency Medicine (AREA)
  • Neurology (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

Family

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) EP3630072B1 (enExample)
JP (1) JP2020528075A (enExample)
KR (3) KR20200016889A (enExample)
CN (3) 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
US11602512B1 (en) 2016-07-22 2023-03-14 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
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
US12186296B1 (en) 2016-07-22 2025-01-07 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
US10195151B2 (en) 2016-09-06 2019-02-05 Jazz Pharmaceuticals International Iii Limited Formulations of (R)-2-amino-3-phenylpropyl carbamate
KR20200016889A (ko) 2017-06-02 2020-02-17 재즈 파마슈티칼즈 아일랜드 리미티드 과다 졸림증을 치료하기 위한 방법 및 조성물
BR112021013766A2 (pt) 2019-03-01 2021-09-21 Flamel Ireland Limited Composições de gama-hidroxibutirato com farmacocinética melhorada no estado alimentado
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
WO2024102718A1 (en) * 2022-11-07 2024-05-16 Axsome Therapeutics Compositions and methods for treating insomnia
US20260199282A1 (en) * 2022-11-30 2026-07-16 Axsome Therapeutics, Inc. Methods and compositions for improving driving performance
US12090126B2 (en) 2022-12-30 2024-09-17 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
US12005036B1 (en) 2022-12-30 2024-06-11 Axsome Malta Ltd. Methods of administering solriamfetol to lactating women
US12102609B2 (en) 2022-12-30 2024-10-01 Axsome Malta Ltd. Methods of administering solriamfetol to lactating women
EP4642446A2 (en) * 2022-12-30 2025-11-05 Axsome Malta Ltd. Methods of administering solriamfetol to lactating women
US11771666B1 (en) 2022-12-30 2023-10-03 Axsome Malta Ltd. Methods of administering solriamfetol to lactating women
EP4719375A1 (en) * 2023-05-30 2026-04-08 Axsome Therapeutics, Inc. Solriamfetol for treating cognitive impairment in a subject with impaired cognition associated with obstructive sleep apnea and excessive daytime sleepiness
EP4766353A1 (en) * 2023-08-21 2026-07-01 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
NZ314570A (en) 1993-06-10 2000-11-24 Lilly Co Eli Treatment of emesis using tetrahydrobenz[cd]indole-6-carboxamides
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
CA2240060C (en) 1996-10-10 2007-07-17 Sk Corporation O-carbamoyl-phenylalaninol compounds, their pharmaceutically useful salts and process for preparing the same
AU4674797A (en) 1996-10-22 1998-05-15 Ortho Pharmaceutical Corporation Phenylalaninol derivatives for the treatment of central nervous system disorders
WO2000038672A2 (en) 1998-12-23 2000-07-06 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
HUP0303243A3 (en) 2001-02-27 2012-07-30 Ortho Mcneil Pharm Inc Carbamate compounds for use in preventing and treating bipolar disorder
MXPA03007720A (es) 2001-02-27 2004-11-12 Johnson & Johnson Compuestos de carbamato para su uso en la prevencion o el tratamiento de transtornos de ansiedad.
RS50676B (sr) 2001-02-27 2010-06-30 Ortho-Mcneil Pharmaceutical Inc. Karbamatna jedinjenja za upotrebu u sprečavanju ili lečenju poremećaja kretanja
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
RU2007119648A (ru) 2004-10-28 2008-12-10 СК Холдингз Ко. Способ лечения депрессии
PL1890684T3 (pl) 2005-06-08 2014-05-30 Sk Biopharmaceuticals Co Ltd Leczenie zaburzeń snu i czuwania
US8552060B2 (en) 2005-06-22 2013-10-08 Sk Biopharmaceuticals Co., Ltd. Methods for treatment of sexual dysfunction
EP1928451B1 (en) 2005-07-26 2011-12-28 SK Biopharmaceuticals Co., LTD Methods for treating substance-related disorders
AU2007313017A1 (en) 2006-10-13 2008-04-24 Janssen Pharmaceutica, N.V. 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
AU2010270971B2 (en) 2009-06-22 2015-08-20 Sk Biopharmaceuticals Co., Ltd. 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
EP2496227B1 (en) 2009-11-06 2019-05-22 SK Biopharmaceuticals Co., Ltd. Methods for treating fibromyalgia syndrome
ES2447295T3 (es) 2009-11-06 2014-03-11 Sk Biopharmaceuticals Co., Ltd. Métodos para el tratamiento del trastorno de déficit de atención/hiperactividad
EP2566462B1 (en) 2010-05-04 2020-07-08 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
US8623913B2 (en) 2010-06-30 2014-01-07 Sk Biopharmaceuticals Co., Ltd. Methods for treating restless legs syndrome
US9610274B2 (en) 2010-06-30 2017-04-04 Sk Biopharmaceuticals Co., Ltd. Methods for treating bipolar disorder
US9050302B2 (en) 2013-03-01 2015-06-09 Jazz Pharmaceuticals Ireland Limited Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
RU2019114940A (ru) 2013-03-13 2019-06-28 ЭРИЭЛ БАЙОФАРМА, ЭлЭлСи Лечение катаплексии
CN105848650A (zh) 2013-07-12 2016-08-10 爵士制药国际Iii有限公司 促进吸烟停止
DK3021838T3 (da) 2013-07-18 2020-08-24 Jazz Pharmaceuticals Ireland Ltd Behandling af fedme
TWI655179B (zh) 2014-02-28 2019-04-01 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
KR20200016889A (ko) 2017-06-02 2020-02-17 재즈 파마슈티칼즈 아일랜드 리미티드 과다 졸림증을 치료하기 위한 방법 및 조성물
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
CA3065522A1 (en) 2018-12-06
KR20230145525A (ko) 2023-10-17
MX390786B (es) 2025-03-21
CN122182538A (zh) 2026-06-12
US20240033243A1 (en) 2024-02-01
US11648232B2 (en) 2023-05-16
CN111201014A (zh) 2020-05-26
PH12019502723A1 (en) 2020-07-13
US20200163927A1 (en) 2020-05-28
WO2018222954A1 (en) 2018-12-06
AU2018278332A1 (en) 2020-01-30
EP3630072A1 (en) 2020-04-08
US10959976B2 (en) 2021-03-30
US20250114322A1 (en) 2025-04-10
KR102726728B1 (ko) 2024-11-05
BR112019025286A2 (pt) 2020-06-23
EP3630072A4 (en) 2021-03-10
NZ760594A (en) 2025-05-02
MX2019014409A (es) 2022-03-17
US10912754B2 (en) 2021-02-09
KR20200016889A (ko) 2020-02-17
CN122398775A (zh) 2026-07-17
JP2020528075A (ja) 2020-09-17
KR20240162165A (ko) 2024-11-14
US20210205257A1 (en) 2021-07-08
US20240189270A1 (en) 2024-06-13
US20200281886A1 (en) 2020-09-10
EP3630072B1 (en) 2026-07-15
US20240180866A1 (en) 2024-06-06
US11865098B1 (en) 2024-01-09
MY203401A (en) 2024-06-26

Similar Documents

Publication Publication Date Title
US11865098B1 (en) Methods and compositions for treating excessive sleepiness
AU2008241012B2 (en) Tapentadol for treating pain from arthritis
US20250032442A1 (en) Methods and compositions for treating cognitive impairment
US20250387382A1 (en) Methods of treating essential tremor
WO2025188619A1 (en) Methods of treating parkinson's disease with t-type calcium channel modulators
ES2357355T3 (es) Axomadol para el tratamiento del dolor en caso de artrosis.
CA2945705A1 (en) Methods for treating hypersomnia
AU2024278948A1 (en) Solriamfetol for treating cognitive impairment in a subject with impaired cognition associated with obstructive sleep apnea and excessive daytime sleepiness
EP4615426A1 (en) Compositions and methods for treating insomnia
US20220211647A1 (en) Compositions and methods for potentiating derivatives of 4-aminophenols

Legal Events

Date Code Title Description
FGA Letters patent sealed or granted (standard patent)