DK3138564T3 - Nalmefen til reduktion af alkoholindtag i specifikke mål-populationer - Google Patents
Nalmefen til reduktion af alkoholindtag i specifikke mål-populationer Download PDFInfo
- Publication number
- DK3138564T3 DK3138564T3 DK16187426.8T DK16187426T DK3138564T3 DK 3138564 T3 DK3138564 T3 DK 3138564T3 DK 16187426 T DK16187426 T DK 16187426T DK 3138564 T3 DK3138564 T3 DK 3138564T3
- Authority
- DK
- Denmark
- Prior art keywords
- nalmefene
- patient
- alcohol
- patients
- longer
- Prior art date
Links
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 title claims abstract description 161
- WJBLNOPPDWQMCH-MBPVOVBZSA-N Nalmefene Chemical compound N1([C@@H]2CC3=CC=C(C=4O[C@@H]5[C@](C3=4)([C@]2(CCC5=C)O)CC1)O)CC1CC1 WJBLNOPPDWQMCH-MBPVOVBZSA-N 0.000 claims abstract description 186
- 229960005297 nalmefene Drugs 0.000 claims abstract description 185
- 230000035622 drinking Effects 0.000 claims abstract description 47
- 208000007848 Alcoholism Diseases 0.000 claims abstract description 44
- 201000007930 alcohol dependence Diseases 0.000 claims abstract description 43
- 238000011282 treatment Methods 0.000 claims description 33
- 230000002829 reductive effect Effects 0.000 claims description 12
- 238000009223 counseling Methods 0.000 claims description 11
- 239000002775 capsule Substances 0.000 claims description 10
- 230000001154 acute effect Effects 0.000 claims description 8
- 208000024891 symptom Diseases 0.000 claims description 8
- 241000995051 Brenda Species 0.000 claims description 7
- 150000003839 salts Chemical class 0.000 claims description 7
- 206010062237 Renal impairment Diseases 0.000 claims description 6
- 238000001784 detoxification Methods 0.000 claims description 6
- NSNHWTBQMQIDCF-UHFFFAOYSA-N dihydrate;hydrochloride Chemical compound O.O.Cl NSNHWTBQMQIDCF-UHFFFAOYSA-N 0.000 claims description 6
- 208000019423 liver disease Diseases 0.000 claims description 6
- 206010010904 Convulsion Diseases 0.000 claims description 5
- 206010012225 Delirium tremens Diseases 0.000 claims description 5
- QCQCHGYLTSGIGX-GHXANHINSA-N 4-[[(3ar,5ar,5br,7ar,9s,11ar,11br,13as)-5a,5b,8,8,11a-pentamethyl-3a-[(5-methylpyridine-3-carbonyl)amino]-2-oxo-1-propan-2-yl-4,5,6,7,7a,9,10,11,11b,12,13,13a-dodecahydro-3h-cyclopenta[a]chrysen-9-yl]oxy]-2,2-dimethyl-4-oxobutanoic acid Chemical compound N([C@@]12CC[C@@]3(C)[C@]4(C)CC[C@H]5C(C)(C)[C@@H](OC(=O)CC(C)(C)C(O)=O)CC[C@]5(C)[C@H]4CC[C@@H]3C1=C(C(C2)=O)C(C)C)C(=O)C1=CN=CC(C)=C1 QCQCHGYLTSGIGX-GHXANHINSA-N 0.000 claims description 4
- 206010053164 Alcohol withdrawal syndrome Diseases 0.000 claims description 4
- 208000004547 Hallucinations Diseases 0.000 claims description 4
- 208000026251 Opioid-Related disease Diseases 0.000 claims description 4
- 239000002253 acid Substances 0.000 claims description 4
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- 230000001419 dependent effect Effects 0.000 claims 1
- 201000005040 opiate dependence Diseases 0.000 claims 1
- 239000006186 oral dosage form Substances 0.000 claims 1
- 230000009467 reduction Effects 0.000 abstract description 32
- 235000019441 ethanol Nutrition 0.000 description 166
- 238000000034 method Methods 0.000 description 60
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- 239000003937 drug carrier Substances 0.000 description 3
- 239000000014 opioid analgesic Substances 0.000 description 3
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 description 2
- 229940127450 Opioid Agonists Drugs 0.000 description 2
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- 210000004185 liver Anatomy 0.000 description 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 2
- 238000012544 monitoring process Methods 0.000 description 2
- 229960003086 naltrexone Drugs 0.000 description 2
- DQCKKXVULJGBQN-XFWGSAIBSA-N naltrexone Chemical compound N1([C@@H]2CC3=CC=C(C=4O[C@@H]5[C@](C3=4)([C@]2(CCC5=O)O)CC1)O)CC1CC1 DQCKKXVULJGBQN-XFWGSAIBSA-N 0.000 description 2
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- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 1
- 239000004233 Indanthrene blue RS Substances 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- HLMSIZPQBSYUNL-IPOQPSJVSA-N Noroxymorphone Chemical compound O=C([C@@H]1O2)CC[C@@]3(O)[C@H]4CC5=CC=C(O)C2=C5[C@@]13CCN4 HLMSIZPQBSYUNL-IPOQPSJVSA-N 0.000 description 1
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- 101100244562 Pseudomonas aeruginosa (strain ATCC 15692 / DSM 22644 / CIP 104116 / JCM 14847 / LMG 12228 / 1C / PRS 101 / PAO1) oprD gene Proteins 0.000 description 1
- 208000028017 Psychotic disease Diseases 0.000 description 1
- 239000004231 Riboflavin-5-Sodium Phosphate Substances 0.000 description 1
- 238000007239 Wittig reaction Methods 0.000 description 1
- 239000004234 Yellow 2G Substances 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 230000000996 additive effect Effects 0.000 description 1
- 239000000556 agonist Substances 0.000 description 1
- 208000025746 alcohol use disease Diseases 0.000 description 1
- 235000019232 alkannin Nutrition 0.000 description 1
- 239000004191 allura red AC Substances 0.000 description 1
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- 239000004178 amaranth Substances 0.000 description 1
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- 239000004148 curcumin Substances 0.000 description 1
- 108700023159 delta Opioid Receptors Proteins 0.000 description 1
- 102000048124 delta Opioid Receptors Human genes 0.000 description 1
- 230000003001 depressive effect Effects 0.000 description 1
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- 238000001914 filtration Methods 0.000 description 1
- 229920000159 gelatin Polymers 0.000 description 1
- 235000019322 gelatine Nutrition 0.000 description 1
- 150000004677 hydrates Chemical class 0.000 description 1
- 239000012729 immediate-release (IR) formulation Substances 0.000 description 1
- 235000019239 indanthrene blue RS Nutrition 0.000 description 1
- 239000004179 indigotine Substances 0.000 description 1
- 235000012738 indigotine Nutrition 0.000 description 1
- 102000048260 kappa Opioid Receptors Human genes 0.000 description 1
- 230000000670 limiting effect Effects 0.000 description 1
- 235000019359 magnesium stearate Nutrition 0.000 description 1
- 230000003340 mental effect Effects 0.000 description 1
- 102000051367 mu Opioid Receptors Human genes 0.000 description 1
- 235000019236 orange GGN Nutrition 0.000 description 1
- 239000004177 patent blue V Substances 0.000 description 1
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- 108020001588 κ-opioid receptors Proteins 0.000 description 1
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Classifications
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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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic 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
- A61K31/47—Quinolines; Isoquinolines
- A61K31/485—Morphinan derivatives, e.g. morphine, codeine
-
- 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
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
- A61P25/32—Alcohol-abuse
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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- Health & Medical Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- Epidemiology (AREA)
- Emergency Medicine (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Physiology (AREA)
- Nutrition Science (AREA)
- Neurology (AREA)
- Addiction (AREA)
- Neurosurgery (AREA)
- Biomedical Technology (AREA)
- Psychiatry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
- Medicinal Preparation (AREA)
- Steroid Compounds (AREA)
Claims (13)
1. Nalmefen til anvendelse i behandlingen af alkoholafhængighed hos en patient med alkoholafhængighed, hvor anvendelsen nedsætter alkoholindtag; hvor patienten med alkoholafhængighed: har et DRL (drikke-risikoniveau) svarende til indtag >60 g/dag af ren alkohol for mænd og >40 g/dag for kvinder; hvor patienten opretholder et DRL svarende til indtag >60 g/dag af ren alkohol for mænd og >40 g/dag for kvinder efter en observationsperiode følgende indledende vurdering; og hvor observationsperioden følgende indledende vurdering er 1-2 uger såsom omkring 2 uger.
2. Nalmefen til anvendelse ifølge krav 1, hvor patienten ikke kræver øjeblikkelig afgiftning og/eller hvor patienten ikke har fysiske symptomer på abstinens.
3. Nalmefen til anvendelse ifølge et hvilket som helst af kravene 1-2, hvor patienten er underlagt igangværende motiverende støtte.
4. Nalmefen til anvendelse ifølge et hvilket som helst af kravene 1-3, hvor patienten er underlagt rådgivning fokuseret på forbedret overholdelse af behandling og nedsat alkoholindtag.
5. Nalmefen til anvendelse ifølge krav 4, hvor rådgivningen udføres ifølge BRENDA-modellen.
6. Nalmefen til anvendelse ifølge et hvilket som helst af kravene 1-5, hvor patienten er en patient for hvem øjeblikkelig afholdenhed ikke er et mål for behandling.
7. Nalmefen til anvendelse ifølge et hvilket som helst af kravene 1-6, hvor nalmefen skal anvendes i en behandlingsperiode på 6-12 måneder, såsom 6 måneder.
8. Nalmefen til anvendelse ifølge et hvilket som helst af kravene 1-7, hvor patienten er et voksent menneske eller et ungt menneske.
9. Nalmefen til anvendelse ifølge et hvilket som helst af kravene 1-8, hvor nalmefen skal anvendes efter behov.
10. Nalmefen til anvendelse ifølge et hvilket som helst af kravene 1-9, hvor patienten ikke falder ind under en eller flere af de følgende kategorier: patienter, der tager smertestillende opioidmidler, opioidafhængige patienter uden succesfuld afvænning, patienter med akutte symptomer på opioidafvænning, patienter, der mistænkes for nylig brug af opioider, patienter med moderat eller alvorlig leversvækkelse, patienter med moderat eller alvorlig nyresvækkelse, patienter med aktuel eller nylig opioidafhængighed, patienter med en nylig historik af akut alkohol-afvænningssyndrom (inklusiv hallucinationer, anfald og delirium tremens).
11. Nalmefen til anvendelse ifølge et hvilket som helst af kravene 1-10, hvor nalmefen anvendes i formen af et farmaceutisk acceptabelt syreadditionssalt.
2. Nalmefen til anvendelse ifølge krav 11, hvor nalmefen anvendes i formen af hydrochlorid-saltet.
13. Nalmefen til anvendelse ifølge krav 12, hvor nalmefen anvendes i formen af hydrochlorid-dihydratet.
14. Nalmefen til anvendelse ifølge et hvilket som helst af kravene 1-13, hvor nalmefen anvendes i en oral dosisform, såsom tabletter eller kapsler.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261664804P | 2012-06-27 | 2012-06-27 | |
| US201261721539P | 2012-11-02 | 2012-11-02 | |
| US201261736740P | 2012-12-13 | 2012-12-13 | |
| US201361788810P | 2013-03-15 | 2013-03-15 | |
| EP13732471.1A EP2866808B1 (en) | 2012-06-27 | 2013-06-27 | Nalmefene for reduction of alcohol consumption in specific target populations |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK3138564T3 true DK3138564T3 (da) | 2018-03-26 |
Family
ID=48703496
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK17206034.5T DK3345604T3 (da) | 2012-06-27 | 2013-06-27 | Nalmefen til reduktion af alkoholindtag i specifikke mål-populationer |
| DK16187426.8T DK3138564T3 (da) | 2012-06-27 | 2013-06-27 | Nalmefen til reduktion af alkoholindtag i specifikke mål-populationer |
| DK13732471.1T DK2866808T3 (da) | 2012-06-27 | 2013-06-27 | Nalmefen til reduktion af alkoholforbruget i specifikke målgrupper |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK17206034.5T DK3345604T3 (da) | 2012-06-27 | 2013-06-27 | Nalmefen til reduktion af alkoholindtag i specifikke mål-populationer |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK13732471.1T DK2866808T3 (da) | 2012-06-27 | 2013-06-27 | Nalmefen til reduktion af alkoholforbruget i specifikke målgrupper |
Country Status (35)
| Country | Link |
|---|---|
| US (4) | US20140005216A1 (da) |
| EP (5) | EP3138564B1 (da) |
| JP (3) | JP6258933B2 (da) |
| KR (1) | KR20150023396A (da) |
| CN (1) | CN104411313A (da) |
| AU (1) | AU2013283281B2 (da) |
| BR (1) | BR112014032555A2 (da) |
| CA (1) | CA2874703C (da) |
| CL (1) | CL2014003484A1 (da) |
| CO (1) | CO7160087A2 (da) |
| CY (3) | CY1118579T1 (da) |
| DK (3) | DK3345604T3 (da) |
| EA (1) | EA029908B1 (da) |
| ES (4) | ES2950492T3 (da) |
| FI (1) | FI3345604T3 (da) |
| HK (1) | HK1255683A1 (da) |
| HR (4) | HRP20161717T1 (da) |
| HU (4) | HUE070621T2 (da) |
| IL (1) | IL236035B (da) |
| LT (3) | LT3138564T (da) |
| ME (2) | ME02587B (da) |
| MX (1) | MX371373B (da) |
| MY (1) | MY166914A (da) |
| NZ (1) | NZ702191A (da) |
| PH (1) | PH12014502798A1 (da) |
| PL (4) | PL3345604T3 (da) |
| PT (3) | PT3138564T (da) |
| RS (2) | RS57046B1 (da) |
| RU (1) | RU2665373C2 (da) |
| SG (1) | SG11201408704WA (da) |
| SI (3) | SI2866808T1 (da) |
| SM (3) | SMT201800164T1 (da) |
| UA (1) | UA114199C2 (da) |
| WO (1) | WO2014001427A1 (da) |
| ZA (1) | ZA201409525B (da) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20140005216A1 (en) | 2012-06-27 | 2014-01-02 | H. Lundbeck A/S | Nalmefene for reduction of alcohol consumption in specific target populations |
| WO2014170353A1 (en) * | 2013-04-17 | 2014-10-23 | H. Lundbeck A/S | Nalmefene for treatment of patients with sleep disorder |
| JP6797691B2 (ja) | 2014-04-22 | 2020-12-09 | 大塚製薬株式会社 | ブレクスピプラゾールとナルメフェンの組み合わせ剤及び物質関連障害を治療するためのその用途 |
| US20170071590A1 (en) * | 2015-09-10 | 2017-03-16 | Suture Armor Llc | Suture anchor |
| KR102699603B1 (ko) | 2018-04-20 | 2024-08-29 | 삼성전자주식회사 | 반도체 메모리 소자 |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3814768A (en) | 1971-11-26 | 1974-06-04 | Lewenstein E | 6-methylene-6-desoxy dihydro morphine and codeine derivatives and pharmaceutically acceptable salts |
| US4535157A (en) | 1983-11-01 | 1985-08-13 | Key Pharmaceuticals, Inc. | Process for making 6-desoxy-6-methylenenaloxone and 6-desoxy-6-methylenenaltrexone |
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| UA102128C2 (en) | 2008-12-05 | 2013-06-10 | Х. Луннбек А/С | Nalmefene hydrochloride dihydrate |
| PL2435439T3 (pl) | 2009-05-25 | 2016-05-31 | H Lundbeck As | Wytwarzanie chlorowodorku nalmefenu z naltreksonu |
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