CO2020008231A2 - Formulaciones inyectables de toxina botulínica y métodos de uso de las mismas que tienen una alta tasa de respuesta y una larga duración del efecto - Google Patents

Formulaciones inyectables de toxina botulínica y métodos de uso de las mismas que tienen una alta tasa de respuesta y una larga duración del efecto

Info

Publication number
CO2020008231A2
CO2020008231A2 CONC2020/0008231A CO2020008231A CO2020008231A2 CO 2020008231 A2 CO2020008231 A2 CO 2020008231A2 CO 2020008231 A CO2020008231 A CO 2020008231A CO 2020008231 A2 CO2020008231 A2 CO 2020008231A2
Authority
CO
Colombia
Prior art keywords
effect
botulinum toxin
methods
response rate
long duration
Prior art date
Application number
CONC2020/0008231A
Other languages
English (en)
Inventor
Roman Rubio
Original Assignee
Revance Therapeutics 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 Revance Therapeutics Inc filed Critical Revance Therapeutics Inc
Publication of CO2020008231A2 publication Critical patent/CO2020008231A2/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/48Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/4886Metalloendopeptidases (3.4.24), e.g. collagenase
    • A61K38/4893Botulinum neurotoxin (3.4.24.69)
    • 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61K47/51Medicinal 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 non-active ingredient being a modifying agent
    • A61K47/62Medicinal 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 non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
    • A61K47/64Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
    • A61K47/645Polycationic or polyanionic oligopeptides, polypeptides or polyamino acids, e.g. polylysine, polyarginine, polyglutamic acid or peptide TAT
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/60Sugars; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/64Proteins; Peptides; Derivatives or degradation products thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/64Proteins; Peptides; Derivatives or degradation products thereof
    • A61K8/66Enzymes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/96Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/99Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from microorganisms other than algae or fungi, e.g. protozoa or bacteria
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61QSPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00Preparations for care of the skin
    • A61Q19/08Anti-ageing preparations
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2800/00Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
    • A61K2800/40Chemical, physico-chemical or functional or structural properties of particular ingredients
    • A61K2800/56Compounds, absorbed onto or entrapped into a solid carrier, e.g. encapsulated perfumes, inclusion compounds, sustained release forms
    • 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
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12YENZYMES
    • C12Y304/00Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/24Metalloendopeptidases (3.4.24)
    • C12Y304/24069Bontoxilysin (3.4.24.69), i.e. botulinum neurotoxin

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Birds (AREA)
  • Dermatology (AREA)
  • Molecular Biology (AREA)
  • Gerontology & Geriatric Medicine (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biotechnology (AREA)
  • Inorganic Chemistry (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Biochemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Materials For Medical Uses (AREA)

Abstract

RESUMEN Esta invención proporciona composiciones inyectables que comprenden toxina botulínica que pueden administrarse a un sujeto para diversos fines terapéuticos, estéticos y/o cosméticos. Las composiciones inyectables incluidas en la invención exhiben una o más ventajas sobre las formulaciones convencionales de toxina botulínica, que incluyen una antigenicidad reducida, una tendencia reducida a experimentar difusión localizada no deseada después de la inyección, una mayor duración de la eficacia clínica o una potencia mejorada, tasas de respondedores más altas, inicio más rápido de la eficacia clínica y/o estabilidad mejorada. De acuerdo con la invención, el tratamiento único de las composiciones por inyección proporciona respuestas clínicas significativas y al menos una duración de efecto de 26 semanas en un sujeto sometido a tratamiento, tal como se proporciona mediante los métodos de tratamiento descritos, así como tasas de respuesta y/o una duración del efecto más larga después de tratamientos subsecuentes.
CONC2020/0008231A 2017-12-04 2020-07-02 Formulaciones inyectables de toxina botulínica y métodos de uso de las mismas que tienen una alta tasa de respuesta y una larga duración del efecto CO2020008231A2 (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201762594529P 2017-12-04 2017-12-04
US201862774850P 2018-12-03 2018-12-03
PCT/US2018/063942 WO2019113133A1 (en) 2017-12-04 2018-12-04 Injectable botulinum toxin formulations and methods of use thereof having high response rate and long effect duration

Publications (1)

Publication Number Publication Date
CO2020008231A2 true CO2020008231A2 (es) 2020-08-10

Family

ID=66750627

Family Applications (1)

Application Number Title Priority Date Filing Date
CONC2020/0008231A CO2020008231A2 (es) 2017-12-04 2020-07-02 Formulaciones inyectables de toxina botulínica y métodos de uso de las mismas que tienen una alta tasa de respuesta y una larga duración del efecto

Country Status (15)

Country Link
US (2) US20200384090A1 (es)
EP (1) EP3720475A4 (es)
JP (1) JP2021505570A (es)
KR (1) KR20200105829A (es)
CN (1) CN111655279A (es)
AU (2) AU2018378465B2 (es)
BR (1) BR112020011098A2 (es)
CA (1) CA3084175A1 (es)
CO (1) CO2020008231A2 (es)
IL (1) IL275032A (es)
MX (1) MX2020005785A (es)
PH (1) PH12020550821A1 (es)
RU (1) RU2020121540A (es)
SG (1) SG11202005239YA (es)
WO (1) WO2019113133A1 (es)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2445521A4 (en) 2009-06-25 2015-08-26 Revance Therapeutics Inc ALBUMINE-FREE BOTULINUM TOXIN FORMULATIONS
MX2019013716A (es) 2017-05-18 2020-10-12 Revance Therapeutics Inc Métodos de tratamiento para la distonía cervical.
EP3675900A4 (en) 2017-08-28 2021-05-05 Revance Therapeutics, Inc. Transmucosal botulinum toxin compositions, kits, and methods for treating bladder disorders
IL298399A (en) 2020-06-05 2023-01-01 Merz Pharma Gmbh & Co Kgaa Treatment of facial wrinkles with the botulinum toxin in high dose and low volume
KR20230086752A (ko) * 2020-10-13 2023-06-15 레반스 테라퓨틱스, 아이엔씨. 경부 근긴장이상증의 치료 방법
US20250268996A1 (en) * 2021-02-21 2025-08-28 Revance Therapeutics, Inc. Methods of and compositions for treatment of upper limb spasticity
CN113432267A (zh) * 2021-06-29 2021-09-24 哈尔滨蛐宝科技有限公司 一种基于wifi的空气消毒智能控制方法和装置
KR20240047418A (ko) * 2021-08-12 2024-04-12 이온 바이오파마, 인크. 일회용 신경독 제형 및 패키징
WO2025064729A1 (en) * 2023-09-19 2025-03-27 Revance Therapeutics, Inc. Treatment with botulinum toxin in patients in need of a rapid onset cosmetic effect and smoother skin appearance

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SG160357A1 (en) * 2005-03-03 2010-04-29 Revance Therapeutics Inc Compositions and methods for topical application and transdermal delivery of botulinum toxins
NZ568216A (en) * 2005-11-17 2012-09-28 Revance Therapeutics Inc Compositions and methods of topical application and transdermal delivery of botulinum toxins with reduced non-toxin proteins
AU2009332947C1 (en) * 2008-12-31 2019-01-03 Revance Therapeutics, Inc. Injectable botulinum toxin formulations
EP2445521A4 (en) * 2009-06-25 2015-08-26 Revance Therapeutics Inc ALBUMINE-FREE BOTULINUM TOXIN FORMULATIONS
US20140242110A1 (en) * 2013-02-28 2014-08-28 Dt Scimed, Llc Dose, localization, and formulation of botulinum toxins in skin and muscle
US9480731B2 (en) * 2013-12-12 2016-11-01 Medy-Tox, Inc. Long lasting effect of new botulinum toxin formulations
JP6821866B2 (ja) * 2014-12-08 2021-01-27 ジェイワイエスケイ・スキン・ソリューションズ・プライベイト・リミテッドJYSK Skin Solutions Pte. Ltd. 担体分子組成物および関連方法
AU2016343748A1 (en) * 2015-10-29 2018-05-17 Revance Therapeutics, Inc. Injectable botulinum toxin formulations and methods of use thereof having long duration of therapeutic or cosmetic effect

Also Published As

Publication number Publication date
IL275032A (en) 2020-07-30
SG11202005239YA (en) 2020-07-29
MX2020005785A (es) 2020-10-28
RU2020121540A3 (es) 2022-04-27
RU2020121540A (ru) 2022-01-10
CA3084175A1 (en) 2019-06-13
WO2019113133A1 (en) 2019-06-13
PH12020550821A1 (en) 2021-05-10
CN111655279A (zh) 2020-09-11
AU2018378465B2 (en) 2025-05-29
JP2021505570A (ja) 2021-02-18
EP3720475A1 (en) 2020-10-14
US20250064905A1 (en) 2025-02-27
BR112020011098A2 (pt) 2020-11-17
EP3720475A4 (en) 2021-09-08
AU2018378465A1 (en) 2020-07-09
AU2025203363A1 (en) 2025-05-29
KR20200105829A (ko) 2020-09-09
US20200384090A1 (en) 2020-12-10

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