JP6445637B2 - うつ病および不安を予防し治療するためのタペンタドール - Google Patents
うつ病および不安を予防し治療するためのタペンタドール Download PDFInfo
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- JP6445637B2 JP6445637B2 JP2017163838A JP2017163838A JP6445637B2 JP 6445637 B2 JP6445637 B2 JP 6445637B2 JP 2017163838 A JP2017163838 A JP 2017163838A JP 2017163838 A JP2017163838 A JP 2017163838A JP 6445637 B2 JP6445637 B2 JP 6445637B2
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- pain
- tapentadol
- depression
- anxiety
- neuropathic
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- KSOYGIQTLKFLTM-UHFFFAOYSA-N n-(benzenesulfonyl)-2-chloropyridine-4-carboxamide Chemical compound C1=NC(Cl)=CC(C(=O)NS(=O)(=O)C=2C=CC=CC=2)=C1 KSOYGIQTLKFLTM-UHFFFAOYSA-N 0.000 description 1
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- 239000011780 sodium chloride Substances 0.000 description 1
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- OGIDPMRJRNCKJF-UHFFFAOYSA-N titanium oxide Inorganic materials [Ti]=O OGIDPMRJRNCKJF-UHFFFAOYSA-N 0.000 description 1
- 230000000699 topical effect Effects 0.000 description 1
- 229960004380 tramadol Drugs 0.000 description 1
- TVYLLZQTGLZFBW-GOEBONIOSA-N tramadol Natural products COC1=CC=CC([C@@]2(O)[C@@H](CCCC2)CN(C)C)=C1 TVYLLZQTGLZFBW-GOEBONIOSA-N 0.000 description 1
- 230000007704 transition Effects 0.000 description 1
- 230000008736 traumatic injury Effects 0.000 description 1
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 description 1
- 150000004670 unsaturated fatty acids Chemical class 0.000 description 1
- 235000021122 unsaturated fatty acids Nutrition 0.000 description 1
- 230000002485 urinary effect Effects 0.000 description 1
- 230000002792 vascular Effects 0.000 description 1
- 210000001835 viscera Anatomy 0.000 description 1
- 208000009935 visceral pain Diseases 0.000 description 1
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- 239000011787 zinc oxide Substances 0.000 description 1
- 235000014692 zinc oxide Nutrition 0.000 description 1
- XOOUIPVCVHRTMJ-UHFFFAOYSA-L zinc stearate Chemical compound [Zn+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O XOOUIPVCVHRTMJ-UHFFFAOYSA-L 0.000 description 1
- 229940057977 zinc stearate Drugs 0.000 description 1
- NWONKYPBYAMBJT-UHFFFAOYSA-L zinc sulfate Chemical compound [Zn+2].[O-]S([O-])(=O)=O NWONKYPBYAMBJT-UHFFFAOYSA-L 0.000 description 1
- 229910000368 zinc sulfate Inorganic materials 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
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
-
- 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
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- 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
- A61P25/04—Centrally acting analgesics, e.g. opioids
-
- 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
- A61P25/06—Antimigraine agents
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- 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
- A61P25/20—Hypnotics; Sedatives
-
- 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
- A61P25/22—Anxiolytics
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- 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
- A61P25/24—Antidepressants
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
Landscapes
- Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Pain & Pain Management (AREA)
- Epidemiology (AREA)
- Emergency Medicine (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Rheumatology (AREA)
- Anesthesiology (AREA)
- Psychiatry (AREA)
- Dermatology (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Description
(i)うつ病をおよび/または不安を患っている対象における、疼痛の、好ましくは神経因性疼痛の、より好ましくは腰髄神経根障害による神経因性疼痛の治療、および/または(ii)うつ病のおよび/または不安の治療または予防、
において使用するためのタペンタドールに向けられており、ただし、タペンタドールが抗てんかん薬と組み合わせて投与されないことを条件とする。
a)うつ病および/または不安を患っている対象における、疼痛の、好ましくは神経因性疼痛の、より好ましくは腰髄神経根障害による神経因性疼痛の治療;
b)うつ病および/または不安を患っている対象におけるうつ病および/または不安の治療;
c)疼痛を、好ましくは神経因性疼痛を、より好ましくは腰髄神経根障害による神経因性疼痛を患っている対象におけるうつ病および/または不安の治療;
d)うつ病および/または不安の予防;
e)疼痛の、好ましくは神経因性疼痛の、より好ましくは腰髄神経根障害による神経因性疼痛の治療、およびうつ病および/または不安の同時治療;および/または
f)疼痛の、好ましくは神経因性疼痛の、より好ましくは腰髄神経根障害による神経因性疼痛の治療、およびうつ病および/または不安の同時の予防、
において使用するためのタペンタドールに関する。
(i)うつ病をおよび/または不安を患っている対象における、疼痛の、好ましくは神経因性疼痛の、より好ましくは腰髄神経根障害による神経因性疼痛の治療、および/または(ii)うつ病のおよび/または不安の治療または予防、
のための方法に関し、ただし、タペンタドールが抗てんかん薬と組み合わせて投与されないことを条件とする。
好ましい塩は塩酸塩である。
(i)うつ病および/または不安を患っている対象における疼痛の治療、および/または(ii)うつ病および/または不安の治療または予防、
に使用するためのものであり、ただし、タペンタドールが抗てんかん薬と組み合わせて投与されないことを条件とする。
(i)うつ病および/または不安を患っている対象における神経因性疼痛の、より好ましくは腰髄神経根障害による神経因性疼痛の治療、および/または
(ii)神経因性疼痛を、より好ましくは腰髄神経根障害による神経因性疼痛を患っている対象におけるうつ病および/または不安の治療および予防、
に使用するためのものであり、好ましくは、タペンタドールが抗てんかん薬と組み合わせて投与されないことを条件とする。
10、20および30日の期間にわたるタペンタドールの投与による不安スコアの平均値の減少を、好ましい実施形態E31〜E35として以下に要約する。各%値は、初期平均不安スコアに対する、所定の期間後に残っている平均不安スコアを示す。
適当なコーティング組成物は、特に、ポリマー酸およびポリマー酸とシェラック、セチルアルコールおよび/または酢酸セルロースのような物質との混合物である。
うつ病および/または不安を患っている対象における疼痛の治療における、ならびにうつ病および/または不安の治療におけるタペンタドール塩酸塩PRおよびタペンタドール塩酸塩IRの有効性が、神経因性の腰痛と混合した重度の慢性侵害受容性疼痛を有する対象での臨床試験において実証された。腰髄神経根障害による神経因性疼痛を患っているサブグループについても調べた。
・典型的な皮膚節の疼痛(膝を通って足への放散痛、座骨/大腿神経の分布内での伸長によって引き起こされる疼痛)
・神経根障害の兆候:
・例えば、腰神経根(L4、L5、S1)の圧縮からの感覚障害、運動症状。
・および/または大腿四頭筋もしくは下腿三頭筋反射の欠損または減少。
・および/または同じ皮膚節領域に存在する定量的感覚試験(QST)欠損および疼痛分布。
Short Form 36(登録商標) Health Survey (SF−36(登録商標))スコア: painDETECT陰性であるかまたは不明/陽性であった患者に関して、ベースラインから12週目までに、SF−36の身体機能、体の痛み、全体的健康感、日常役割機能(精神)および身体的コンポーネント・サマリースコアが改善し(全てP<0.05);不明/陽性であった患者に関しては、日常役割機能(身体)、活力、社会生活機能、心の健康、報告された健康転換、および精神的コンポーネント・サマリースコアも改善した(全てP<0.05)。
(i)Nは指定された診断群の対象の数であり、
(ii)nは利用可能なデータを有する対象の数であり、
(iii)「平均」は、対象の平均スコアであり、すなわち、全スコアの合計を対象の数で割る、
(iv)SDは標準偏差であり、
(v)「メジアン」は、対象のメジアンスコア、すなわち、スコアセットにおける中央のスコアであり、
(vi)「範囲」は、対象のスコアの範囲、すなわち、スコアセットの最低スコアと最高スコアによって定義される範囲である。
(1)
(i)うつ病および/または不安を患っている対象における疼痛の治療、および/または(ii)うつ病および/または不安の治療または予防、
における使用のためのタペンタドールであって、ただし、タペンタドールが抗てんかん薬と組み合わせて投与されないことを条件とする、タペンタドール。
(2)
タペンタドールがAMPA受容体アンタゴニストと組み合わせて投与されないことを条件とする、前記(1)記載の使用のためのタペンタドール。
(3)
タペンタドールが唯一の薬理学的に活性な成分として投与される、前記(1)または(2)に記載の使用のためのタペンタドール。
(4)
タペンタドールが経口で投与される、前記(1)〜(3)のいずれか1つに記載の使用のためのタペンタドール。
(5)
タペンタドールが
−毎日1日1回または1日2回、および/または
−25〜600mgの範囲内の1日用量で、
投与される、前記(1)〜(4)のいずれか1つに記載の使用のためのタペンタドール。
(6)
疼痛が中等度または重度である、前記(1)〜(5)のいずれか1つに記載の使用のためのタペンタドール。
(7)
疼痛が慢性である、前記(1)〜(6)のいずれか1つに記載の使用のためのタペンタドール。
(8)
慢性疼痛が、癌性疼痛、化学療法によって誘発された疼痛、上背部痛、腰痛、リウマチ疾患に関連する疼痛を含む炎症性疼痛、関節性痛、強直性脊椎炎、筋膜の疼痛、筋骨格障害に関連する疼痛、筋肉痛、骨痛、関節痛、線維筋痛症に関連する慢性疼痛、過労/捻挫からの疼痛、持続性の術後疼痛、持続性の外傷後疼痛、腎疝痛、過敏性大腸症候群に関連する疼痛、消化器痛、骨盤痛、腹痛、虚血性疼痛、アンギナ疼痛、跛行に関連する疼痛、心筋梗塞に伴う疼痛、血管痛、中枢神経系外傷に関連する疼痛、顔面痛、片頭痛に関連する疼痛、頭痛に関連する疼痛、口顔の疼痛、損傷したもしくは炎症した体細胞組織に由来する持続性疼痛、およびこれらの組み合わせからなる群から選択される、前記(7)記載の使用のためのタペンタドール。
(9)
疼痛が、神経因性疼痛、侵害受容性疼痛、心因性疼痛、幻想痛およびそれらの混合から選択される、前記(1)〜(7)のいずれか1つに記載の使用のためのタペンタドール。
(10)
疼痛が神経因性である、前記(9)記載の使用のためのタペンタドール。
(11)
神経因性疼痛が、糖尿病性神経痛、単神経根神経障害、三叉神経痛、ヘルペス後神経痛、持続性術後もしくは外傷後疼痛、痛覚過敏、異痛症、線維筋痛症、CRPS、多発性硬化症に関連する疼痛、AIDSに関連するニューロパシー、視床痛、脊髄障害により引き起こされる対麻痺の疼痛、有痛性感覚消失、腰痛、反射性交感神経性ジストロフィー/カウザルギー、癌性疼痛、化学療法によって誘発された疼痛、開胸術後疼痛、エントラップメントニューロパチーおよび末梢神経障害からなる群から選択される、前記(9)または(10)に記載の使用のためのタペンタドール。
(12)
うつ病および/または不安が、疼痛を患っている対象における疼痛によって誘発される、前記(1)〜(11)のいずれか1つに記載の使用のためのタペンタドール。
(13)
うつ病および/または不安が心因性疼痛を誘発する、前記(1)〜(12)のいずれか1つに記載の使用のためのタペンタドール。
(14)
うつ病および/または不安が、抑うつ障害、全般性不安障害、パニック発作、不眠症、自殺念慮、社会的抑制、エネルギーの喪失、絶望、無快感症、気分障害、被刺激性、障害、胃腸障害、皮膚反応、背部痛、胸痛、頭痛、筋肉痛および非特異的な疼痛および痛みからなる群から選択される1種またはそれ以上の症状を誘発する、前記(1)〜(13)のいずれか1つに記載の使用のためのタペンタドール。
(15)
a)うつ病および/または不安を患っている対象における疼痛の治療;
b)うつ病および/または不安を患っている対象におけるうつ病および/または不安の治療;
c)疼痛を患っている対象におけるうつ病および/または不安の治療;
d)うつ病および/または不安の予防;
e)疼痛の治療、およびうつ病および/または不安の同時の治療;および/または
f)疼痛の治療、およびうつ病および/または不安の同時の予防、
において使用するためのものである、前記(1)〜(14)のいずれか1つに記載の使用のためのタペンタドール。
Claims (8)
- i)疼痛を患っている対象におけるうつ病および/または不安の治療または予防;または
ii)疼痛の治療、およびうつ病および/または不安の同時治療または予防
のためのタペンタドール含有医薬組成物であって、この組成物はタペンタドールを抗てんかん薬と組み合わせて含まず、そして上記疼痛は神経因性であるが、神経因性腰痛でないことを条件とする、上記タペンタドール含有医薬組成物。 - 前記組成物がタペンタドールをAMPA受容体アンタゴニストと組み合わせて含まないことを条件とする、請求項1記載のタペンタドール含有医薬組成物。
- 前記組成物がタペンタドールを唯一の薬理学的に活性な成分として含有する、請求項1または2に記載のタペンタドール含有医薬組成物。
- 前記組成物が経口で投与される、請求項1〜3のいずれか1つに記載のタペンタドール含有医薬組成物。
- 前記組成物が
−毎日1日1回または1日2回、および/または
−25〜600mgの範囲内の1日用量で、
投与される、請求項1〜4いずれか1つに記載のタペンタドール含有医薬組成物。 - 前記疼痛が中等度または重度である、請求項1〜5のいずれか1つに記載のタペンタドール含有医薬組成物。
- 前記疼痛が慢性である、請求項1〜6のいずれか1つに記載のタペンタドール含有医薬組成物。
- 神経因性疼痛が、糖尿病性神経痛、単神経根神経障害、三叉神経痛、ヘルペス後神経痛、持続性術後もしくは外傷後疼痛、痛覚過敏、異痛症、線維筋痛症、CRPS、多発性硬化症に関連する疼痛、AIDSに関連するニューロパシー、視床痛、脊髄障害により引き起こされる対麻痺の疼痛、有痛性感覚消失、反射性交感神経性ジストロフィー/カウザルギー、癌性疼痛、化学療法によって誘発された疼痛、開胸術後疼痛、エントラップメントニューロパチーおよび末梢神経障害からなる群から選択される、請求項1〜7のいずれか1つに記載のタペンタドール含有医薬組成物。
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JP2016183088A Pending JP2017031182A (ja) | 2011-04-29 | 2016-09-20 | うつ病および不安を予防し治療するためのタペンタドール |
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JP2016183088A Pending JP2017031182A (ja) | 2011-04-29 | 2016-09-20 | うつ病および不安を予防し治療するためのタペンタドール |
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EP (3) | EP3272343B1 (ja) |
JP (3) | JP6014655B2 (ja) |
CY (2) | CY1119586T1 (ja) |
DK (2) | DK2701693T3 (ja) |
ES (2) | ES2788548T3 (ja) |
HR (2) | HRP20171570T1 (ja) |
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LT (2) | LT2701693T (ja) |
NO (1) | NO2701693T3 (ja) |
PL (2) | PL2701693T3 (ja) |
PT (2) | PT3272343T (ja) |
RS (2) | RS60152B1 (ja) |
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