CA2974091A1 - Intravenous baclofen formulations and treatment methods - Google Patents
Intravenous baclofen formulations and treatment methods Download PDFInfo
- Publication number
- CA2974091A1 CA2974091A1 CA2974091A CA2974091A CA2974091A1 CA 2974091 A1 CA2974091 A1 CA 2974091A1 CA 2974091 A CA2974091 A CA 2974091A CA 2974091 A CA2974091 A CA 2974091A CA 2974091 A1 CA2974091 A1 CA 2974091A1
- Authority
- CA
- Canada
- Prior art keywords
- baclofen
- oral
- solution
- administration
- subject
- 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.)
- Abandoned
Links
- KPYSYYIEGFHWSV-UHFFFAOYSA-N Baclofen Chemical compound OC(=O)CC(CN)C1=CC=C(Cl)C=C1 KPYSYYIEGFHWSV-UHFFFAOYSA-N 0.000 title claims abstract description 144
- 229960000794 baclofen Drugs 0.000 title claims abstract description 140
- 238000001990 intravenous administration Methods 0.000 title claims abstract description 77
- 238000000034 method Methods 0.000 title claims abstract description 40
- 239000000203 mixture Substances 0.000 title description 10
- 238000009472 formulation Methods 0.000 title description 9
- 239000000243 solution Substances 0.000 claims description 44
- 238000007913 intrathecal administration Methods 0.000 claims description 38
- 238000001802 infusion Methods 0.000 claims description 16
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 11
- 239000003814 drug Substances 0.000 claims description 6
- 229940079593 drug Drugs 0.000 claims description 6
- 208000014674 injury Diseases 0.000 claims description 6
- 238000001356 surgical procedure Methods 0.000 claims description 6
- 206010010904 Convulsion Diseases 0.000 claims description 5
- 206010012735 Diarrhoea Diseases 0.000 claims description 5
- 206010025476 Malabsorption Diseases 0.000 claims description 5
- 208000004155 Malabsorption Syndromes Diseases 0.000 claims description 5
- 208000006011 Stroke Diseases 0.000 claims description 5
- 208000032851 Subarachnoid Hemorrhage Diseases 0.000 claims description 5
- 208000007271 Substance Withdrawal Syndrome Diseases 0.000 claims description 5
- 206010047700 Vomiting Diseases 0.000 claims description 5
- 230000002496 gastric effect Effects 0.000 claims description 5
- 208000008384 ileus Diseases 0.000 claims description 5
- 208000003243 intestinal obstruction Diseases 0.000 claims description 5
- 230000008733 trauma Effects 0.000 claims description 5
- 230000008673 vomiting Effects 0.000 claims description 5
- 239000000812 cholinergic antagonist Substances 0.000 claims description 4
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Chemical compound OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims description 3
- BPKIGYQJPYCAOW-FFJTTWKXSA-I calcium;potassium;disodium;(2s)-2-hydroxypropanoate;dichloride;dihydroxide;hydrate Chemical compound O.[OH-].[OH-].[Na+].[Na+].[Cl-].[Cl-].[K+].[Ca+2].C[C@H](O)C([O-])=O BPKIGYQJPYCAOW-FFJTTWKXSA-I 0.000 claims description 3
- 239000003242 anti bacterial agent Substances 0.000 claims description 2
- 239000001961 anticonvulsive agent Substances 0.000 claims description 2
- 230000003115 biocidal effect Effects 0.000 claims description 2
- 239000003186 pharmaceutical solution Substances 0.000 claims description 2
- 230000001225 therapeutic effect Effects 0.000 claims description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 6
- BTCSSZJGUNDROE-UHFFFAOYSA-N gamma-aminobutyric acid Chemical compound NCCCC(O)=O BTCSSZJGUNDROE-UHFFFAOYSA-N 0.000 description 4
- 230000036470 plasma concentration Effects 0.000 description 4
- 239000011780 sodium chloride Substances 0.000 description 4
- 239000008227 sterile water for injection Substances 0.000 description 4
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 description 3
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 3
- 210000004369 blood Anatomy 0.000 description 3
- 239000008280 blood Substances 0.000 description 3
- OGNSCSPNOLGXSM-UHFFFAOYSA-N (+/-)-DABA Natural products NCCC(N)C(O)=O OGNSCSPNOLGXSM-UHFFFAOYSA-N 0.000 description 2
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 2
- 230000002411 adverse Effects 0.000 description 2
- 238000001647 drug administration Methods 0.000 description 2
- 229960003692 gamma aminobutyric acid Drugs 0.000 description 2
- 238000007427 paired t-test Methods 0.000 description 2
- 239000000843 powder Substances 0.000 description 2
- 238000011002 quantification Methods 0.000 description 2
- 208000024891 symptom Diseases 0.000 description 2
- 238000002560 therapeutic procedure Methods 0.000 description 2
- BVPWJMCABCPUQY-UHFFFAOYSA-N 4-amino-5-chloro-2-methoxy-N-[1-(phenylmethyl)-4-piperidinyl]benzamide Chemical compound COC1=CC(N)=C(Cl)C=C1C(=O)NC1CCN(CC=2C=CC=CC=2)CC1 BVPWJMCABCPUQY-UHFFFAOYSA-N 0.000 description 1
- USFZMSVCRYTOJT-UHFFFAOYSA-N Ammonium acetate Chemical compound N.CC(O)=O USFZMSVCRYTOJT-UHFFFAOYSA-N 0.000 description 1
- 239000005695 Ammonium acetate Substances 0.000 description 1
- 238000012371 Aseptic Filling Methods 0.000 description 1
- 208000004547 Hallucinations Diseases 0.000 description 1
- 208000007101 Muscle Cramp Diseases 0.000 description 1
- 208000008238 Muscle Spasticity Diseases 0.000 description 1
- 206010053159 Organ failure Diseases 0.000 description 1
- 241000233805 Phoenix Species 0.000 description 1
- 206010039020 Rhabdomyolysis Diseases 0.000 description 1
- 208000005392 Spasm Diseases 0.000 description 1
- 101150006765 TTI2 gene Proteins 0.000 description 1
- ATJFFYVFTNAWJD-UHFFFAOYSA-N Tin Chemical compound [Sn] ATJFFYVFTNAWJD-UHFFFAOYSA-N 0.000 description 1
- 206010048010 Withdrawal syndrome Diseases 0.000 description 1
- 208000027418 Wounds and injury Diseases 0.000 description 1
- 239000000556 agonist Substances 0.000 description 1
- VREFGVBLTWBCJP-UHFFFAOYSA-N alprazolam Chemical compound C12=CC(Cl)=CC=C2N2C(C)=NN=C2CN=C1C1=CC=CC=C1 VREFGVBLTWBCJP-UHFFFAOYSA-N 0.000 description 1
- 229940043376 ammonium acetate Drugs 0.000 description 1
- 235000019257 ammonium acetate Nutrition 0.000 description 1
- 230000001663 anti-spastic effect Effects 0.000 description 1
- 238000013459 approach Methods 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- UUSQFLGKGQEVCM-UHFFFAOYSA-M benzoxonium chloride Chemical compound [Cl-].CCCCCCCCCCCC[N+](CCO)(CCO)CC1=CC=CC=C1 UUSQFLGKGQEVCM-UHFFFAOYSA-M 0.000 description 1
- 229960001574 benzoxonium chloride Drugs 0.000 description 1
- 208000029028 brain injury Diseases 0.000 description 1
- 206010008129 cerebral palsy Diseases 0.000 description 1
- 210000001175 cerebrospinal fluid Anatomy 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 230000006378 damage Effects 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 238000010579 first pass effect Methods 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 230000003862 health status Effects 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 238000011459 intrathecal therapy Methods 0.000 description 1
- 229960004002 levetiracetam Drugs 0.000 description 1
- HPHUVLMMVZITSG-ZCFIWIBFSA-N levetiracetam Chemical compound CC[C@H](C(N)=O)N1CCCC1=O HPHUVLMMVZITSG-ZCFIWIBFSA-N 0.000 description 1
- 229940063721 lioresal Drugs 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 230000003278 mimic effect Effects 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 210000002161 motor neuron Anatomy 0.000 description 1
- 201000006417 multiple sclerosis Diseases 0.000 description 1
- 210000003205 muscle Anatomy 0.000 description 1
- 239000003158 myorelaxant agent Substances 0.000 description 1
- 208000015122 neurodegenerative disease Diseases 0.000 description 1
- 239000002858 neurotransmitter agent Substances 0.000 description 1
- 229910052757 nitrogen Inorganic materials 0.000 description 1
- 230000009965 odorless effect Effects 0.000 description 1
- 230000001376 precipitating effect Effects 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 108090000623 proteins and genes Proteins 0.000 description 1
- 102000004169 proteins and genes Human genes 0.000 description 1
- 238000003908 quality control method Methods 0.000 description 1
- 239000012488 sample solution Substances 0.000 description 1
- 208000018198 spasticity Diseases 0.000 description 1
- 210000000278 spinal cord Anatomy 0.000 description 1
- 208000020431 spinal cord injury Diseases 0.000 description 1
- 208000005809 status epilepticus Diseases 0.000 description 1
- 239000008223 sterile water Substances 0.000 description 1
- 208000011580 syndromic disease Diseases 0.000 description 1
- 230000001839 systemic circulation Effects 0.000 description 1
- 230000009885 systemic effect Effects 0.000 description 1
- 238000004448 titration Methods 0.000 description 1
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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- 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
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- 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
- A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Neurology (AREA)
- Engineering & Computer Science (AREA)
- Dermatology (AREA)
- Biomedical Technology (AREA)
- Psychology (AREA)
- Neurosurgery (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Orthopedic Medicine & Surgery (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201562103902P | 2015-01-15 | 2015-01-15 | |
| US62/103,902 | 2015-01-15 | ||
| PCT/US2016/013672 WO2016115504A1 (en) | 2015-01-15 | 2016-01-15 | Intravenous baclofen formulations and treatment methods |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2974091A1 true CA2974091A1 (en) | 2016-07-21 |
Family
ID=56406482
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2974091A Abandoned CA2974091A1 (en) | 2015-01-15 | 2016-01-15 | Intravenous baclofen formulations and treatment methods |
Country Status (6)
| Country | Link |
|---|---|
| US (5) | US10350183B2 (cg-RX-API-DMAC7.html) |
| EP (1) | EP3244884A4 (cg-RX-API-DMAC7.html) |
| JP (1) | JP2018502924A (cg-RX-API-DMAC7.html) |
| CA (1) | CA2974091A1 (cg-RX-API-DMAC7.html) |
| MX (1) | MX2017009313A (cg-RX-API-DMAC7.html) |
| WO (1) | WO2016115504A1 (cg-RX-API-DMAC7.html) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2018502924A (ja) | 2015-01-15 | 2018-02-01 | アレイシス、 エルエルシーＡｌｌａｙｓｉｓ， Ｌｌｃ | 静脈内バクロフェン製剤および治療方法 |
| US20170112789A1 (en) * | 2015-10-21 | 2017-04-27 | Allaysis, Llc | Intravenous baclofen and methods of treatment |
| CN115916136A (zh) * | 2020-06-22 | 2023-04-04 | 奥迪威公司 | 使用抗痉挛组合物和负压疗法来治疗痉挛的方法 |
| EP4019016A1 (en) * | 2020-12-24 | 2022-06-29 | Allaysis, LLC | Methods of administering intravenous baclofen |
Family Cites Families (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PH26730A (en) | 1988-12-30 | 1992-09-28 | Ciba Geigy Ag | Coated adhesive tablets |
| DE69103968T2 (de) | 1990-06-15 | 1995-03-23 | Synthelabo | 2-(Aminoalkyl)-5-(arylalkyl)1,3-dioxanderivate, ihre Herstellung und ihre Anwendung in der Therapeutik. |
| IT1319275B1 (it) * | 1999-10-08 | 2003-09-26 | Neuroscienze S C A R L | Uso del baclofen nel trattamento dell'astinenza da etanolo. |
| US6969383B2 (en) * | 2002-09-27 | 2005-11-29 | Medtronic, Inc. | Method for treating severe tinnitus |
| US20060089335A1 (en) * | 2003-10-14 | 2006-04-27 | Guosong Liu | Compositions and methods for enhancing cognitive function and synaptic plasticity |
| US7824697B2 (en) | 2004-07-12 | 2010-11-02 | Board Of Regents, The University Of Texas System | High concentration baclofen preparations |
| PT2083811T (pt) * | 2006-11-22 | 2017-01-23 | Clinical Res Ass Llc | Métodos de tratamento da síndrome de down, síndrome do x frágil e autismo |
| US9180108B2 (en) * | 2011-10-27 | 2015-11-10 | Medtronic, Inc. | Baclofen formulations and methods for making same |
| WO2013180796A1 (en) * | 2012-06-01 | 2013-12-05 | Lynn Health Science Institute, Inc. | Methods for treating insomnia |
| JP2018502924A (ja) | 2015-01-15 | 2018-02-01 | アレイシス、 エルエルシーＡｌｌａｙｓｉｓ， Ｌｌｃ | 静脈内バクロフェン製剤および治療方法 |
-
2016
- 2016-01-15 JP JP2017556780A patent/JP2018502924A/ja active Pending
- 2016-01-15 EP EP16737994.0A patent/EP3244884A4/en not_active Withdrawn
- 2016-01-15 WO PCT/US2016/013672 patent/WO2016115504A1/en not_active Ceased
- 2016-01-15 MX MX2017009313A patent/MX2017009313A/es unknown
- 2016-01-15 CA CA2974091A patent/CA2974091A1/en not_active Abandoned
- 2016-01-15 US US14/997,135 patent/US10350183B2/en active Active
-
2019
- 2019-07-01 US US16/459,004 patent/US20200038353A1/en not_active Abandoned
- 2019-07-01 US US16/458,994 patent/US10933042B2/en active Active
-
2021
- 2021-02-01 US US17/164,366 patent/US20210228520A1/en not_active Abandoned
-
2023
- 2023-04-19 US US18/136,777 patent/US12295929B2/en active Active
Also Published As
| Publication number | Publication date |
|---|---|
| US20190388373A1 (en) | 2019-12-26 |
| US20210228520A1 (en) | 2021-07-29 |
| JP2018502924A (ja) | 2018-02-01 |
| US20230248679A1 (en) | 2023-08-10 |
| EP3244884A4 (en) | 2018-07-25 |
| US20160213631A1 (en) | 2016-07-28 |
| MX2017009313A (es) | 2018-02-09 |
| US10350183B2 (en) | 2019-07-16 |
| WO2016115504A1 (en) | 2016-07-21 |
| US12295929B2 (en) | 2025-05-13 |
| US10933042B2 (en) | 2021-03-02 |
| EP3244884A1 (en) | 2017-11-22 |
| US20200038353A1 (en) | 2020-02-06 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US12295929B2 (en) | Intravenous baclofen formulations and treatment methods | |
| JP2013505983A5 (cg-RX-API-DMAC7.html) | ||
| RU2012117563A (ru) | Режим дозирования модулятора рецептора s1p | |
| Naritoku et al. | Intravenous loading of valproate for epilepsy | |
| JP6935393B2 (ja) | セバコイルジナルブフィンエステルの徐放のための医薬製剤 | |
| EP4547218A1 (en) | Tirzepatide compositions and use | |
| EP4192473B1 (en) | Methods of treatment using furosemide | |
| AU2018388417B2 (en) | Treatment of exercise-induced hypoglycemia in type 1 and insulin using type 2 diabetes | |
| US20170112789A1 (en) | Intravenous baclofen and methods of treatment | |
| US10183018B2 (en) | Pharmaceutical formulations for sustained release of sebacoyl dinalbuphine ester | |
| US20220071987A1 (en) | Pharmaceutical formulations for sustained release of sebacoyl dinalbuphine ester | |
| JP2018531271A6 (ja) | 静脈内バクロフェン及び治療方法 | |
| US20200030318A1 (en) | Pharmaceutical formulations for sustained release of sebacoyl dinalbuphine ester | |
| Aguirre et al. | REPORTS OF ORIGINAL INVESTIGATIONS | |
| KR20150027160A (ko) | 척추 투여용 과포화 아세타미노펜 주사 용액 |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Discontinued |
Effective date: 20220406 |
|
| FZDE | Discontinued |
Effective date: 20220406 |