EP3500261A4 - Liquid naloxone spray - Google Patents

Liquid naloxone spray Download PDF

Info

Publication number
EP3500261A4
EP3500261A4 EP17841883.6A EP17841883A EP3500261A4 EP 3500261 A4 EP3500261 A4 EP 3500261A4 EP 17841883 A EP17841883 A EP 17841883A EP 3500261 A4 EP3500261 A4 EP 3500261A4
Authority
EP
European Patent Office
Prior art keywords
naloxone spray
liquid
liquid naloxone
spray
naloxone
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
EP17841883.6A
Other languages
German (de)
French (fr)
Other versions
EP3500261A1 (en
Inventor
Kiran AMANCHA
Shivani CHILAMPALLI
Thrimoorthy Potta
Ningxin YAN
Venkat R. Goskonda
Eshwaran Narayanan
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.)
Hikma Pharmaceuticals USA Inc
Original Assignee
Hikma Pharmaceuticals USA 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
Priority claimed from US15/238,909 external-priority patent/US10722510B2/en
Priority claimed from US15/601,331 external-priority patent/US10617686B2/en
Application filed by Hikma Pharmaceuticals USA Inc filed Critical Hikma Pharmaceuticals USA Inc
Publication of EP3500261A1 publication Critical patent/EP3500261A1/en
Publication of EP3500261A4 publication Critical patent/EP3500261A4/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
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/485Morphinan derivatives, e.g. morphine, codeine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • 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
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • 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
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K9/0043Nose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
EP17841883.6A 2016-08-17 2017-08-10 Liquid naloxone spray Pending EP3500261A4 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US15/238,909 US10722510B2 (en) 2014-07-08 2016-08-17 Liquid naloxone spray
US15/601,331 US10617686B2 (en) 2014-07-08 2017-05-22 Liquid naloxone spray
PCT/US2017/046198 WO2018034920A1 (en) 2016-08-17 2017-08-10 Liquid naloxone spray

Publications (2)

Publication Number Publication Date
EP3500261A1 EP3500261A1 (en) 2019-06-26
EP3500261A4 true EP3500261A4 (en) 2020-05-06

Family

ID=61197156

Family Applications (1)

Application Number Title Priority Date Filing Date
EP17841883.6A Pending EP3500261A4 (en) 2016-08-17 2017-08-10 Liquid naloxone spray

Country Status (7)

Country Link
EP (1) EP3500261A4 (en)
JP (2) JP7114570B2 (en)
CN (1) CN109922805A (en)
AU (1) AU2017312811B2 (en)
CA (1) CA3033897C (en)
MA (1) MA45995A (en)
WO (1) WO2018034920A1 (en)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10598672B2 (en) 2014-02-18 2020-03-24 Cyrano Therapeutics, Inc. Methods and compositions for diagnosing and treating loss and/or distortion of taste or smell
EP3500261A4 (en) 2016-08-17 2020-05-06 Hikma Pharmaceuticals USA Inc. Liquid naloxone spray
US20180193332A1 (en) * 2017-10-09 2018-07-12 Adapt Pharma Operations Limited Low-temperature stable opioid antagonist solutions
US11129795B2 (en) 2019-02-21 2021-09-28 Pharmaceutical Productions, Inc. Naloxone formulations for sublingual and/or buccal administration
CN112138250B (en) * 2019-06-28 2023-04-14 四川普锐特药业有限公司 Medicament fluid dispenser and dexmedetomidine nasal spray device for maintaining uniform administration
WO2021158957A1 (en) * 2020-02-05 2021-08-12 Summit Biosciences Inc. Drug products for intranasal administration and uses thereof
WO2023133463A1 (en) * 2022-01-06 2023-07-13 Cyrano Therapeutics, Inc. Improved nasal administration of parkinson's therapeutics

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1575795A (en) * 2003-06-25 2005-02-09 中国人民解放军军事医学科学院毒物药物研究所 Naloxone hydrochloride nasal spray
US20160199294A1 (en) * 2014-07-08 2016-07-14 Insys Development Company, Inc. Sublingual naloxone spray

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US585A (en) 1838-01-27 Apparatus for extinguishing sparks in the chimneys oe steam-boilers
US14730A (en) 1856-04-22 Improvement in corn-harvesters
US8627816B2 (en) * 2011-02-28 2014-01-14 Intelliject, Inc. Medicament delivery device for administration of opioid antagonists including formulations for naloxone
DK2706982T4 (en) 2011-05-13 2021-05-10 Euro Celtique Sa INTRANASAL PHARMACEUTICAL DOSAGE FORMS INCLUDING NALOXON
CA2834327C (en) * 2011-09-19 2017-05-30 Orexo Ab New abuse-resistant pharmaceutical composition for the treatment of opioid dependence
US8940052B2 (en) 2012-07-26 2015-01-27 DePuy Synthes Products, LLC Expandable implant
CA2881144A1 (en) * 2012-11-09 2014-05-09 Purdue Pharma Pharmaceutical compositions comprising hydromorphone and naloxone
EP3043777B1 (en) 2013-09-10 2020-04-22 Fresh Cut Development, LLC Sublingual buprenorphine spray
CN103637987B (en) 2013-12-09 2015-12-02 韩彬 The composition of liquid medicine of oxycodone
CA2875384A1 (en) 2013-12-20 2015-06-20 AntiOP, Inc. Intranasal naloxone compositions and methods of making and using same
US9480644B2 (en) 2014-03-14 2016-11-01 Opiant Pharmaceuticals, Inc. Nasal drug products and methods of their use
CN110755372A (en) 2014-03-14 2020-02-07 欧皮安特制药有限公司 Pharmaceutical product suitable for nasal delivery, pharmaceutical composition for intranasal administration and use thereof
WO2016007245A1 (en) 2014-07-08 2016-01-14 Insys Pharma, Inc. Sublingual naloxone spray
EP3500261A4 (en) 2016-08-17 2020-05-06 Hikma Pharmaceuticals USA Inc. Liquid naloxone spray

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1575795A (en) * 2003-06-25 2005-02-09 中国人民解放军军事医学科学院毒物药物研究所 Naloxone hydrochloride nasal spray
US20160199294A1 (en) * 2014-07-08 2016-07-14 Insys Development Company, Inc. Sublingual naloxone spray

Also Published As

Publication number Publication date
JP2019528278A (en) 2019-10-10
AU2017312811B2 (en) 2023-03-16
WO2018034920A1 (en) 2018-02-22
MA45995A (en) 2019-06-26
CN109922805A (en) 2019-06-21
EP3500261A1 (en) 2019-06-26
CA3033897C (en) 2024-03-26
AU2017312811A1 (en) 2019-03-07
JP7455157B2 (en) 2024-03-25
JP2022119843A (en) 2022-08-17
JP7114570B2 (en) 2022-08-08
CA3033897A1 (en) 2018-02-22
AU2017312811A8 (en) 2019-03-14

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