JP2018150375A - 多発性硬化症を処置するための併用療法 - Google Patents
多発性硬化症を処置するための併用療法 Download PDFInfo
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- dimethyl fumarate
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- 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
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- 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
- A61K31/4704—2-Quinolinones, e.g. carbostyril
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- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
- A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
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- A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
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Abstract
Description
本発明は、フマル酸ジメチルである第1医薬活性成分またはその薬学的に許容される投与形と、テリフルノミド、フィンゴリモドおよびラキニモド(laquinimod)から選択される第2医薬活性成分またはその薬学的に許容される投与形の固定された組み合わせを含む、経口用医薬組成物、ならびに、多発性硬化症の処置における当該組成物の使用に関する。本発明によるフマル酸ジメチルとテリフルノミドまたはフィンゴリモドまたはラキニモドの組み合わせの使用は、フマル酸ジメチル、および/または、テリフルノミド、フィンゴリモドおよびラキニモドから選択される薬物の用量を、以前に有効性のために必要と考えられていたレベルよりも減らすことを可能にすると同時に、個々の薬物で見られるものと同等の有害作用でより良い有効性を達成する。選択された用量に依存して、併用療法は、個々の薬物それぞれを単独で最適有効投与量で与えたときと比べて、付随する副作用が少なく、劣らない有効性も達成できる。本発明による併用は、投与頻度を減らすことも可能にし得る。
多発性硬化症(MS)は、中枢神経系(CNS)のミエリン化軸索を攻撃する慢性炎症性疾患である。MSは、T細胞が誘発する自己免疫性炎症反応と、それに伴うB細胞活性化、単球およびマクロファージの関与、サイトカインの分泌および血液脳関門の崩壊が原因であると考えられている。ミエリンが失われたとき、神経は、もはや有効にシグナルを伝達できず、感覚消失、運動機能不全、視力障害、膀胱および腸の障害、性機能不全、疲労および認知障害さえ含む多くの臨床症状を起こし得る。
上記試験において、7mgの投与は14mgの投与より有効性が幾らか低いようだが、両方の投与が、2012年にRRMS処置のためにFDAによって承認された。
本発明は、その最も広い局面において、多発性硬化症を処置するための経口薬の新規組み合わせ、すなわち、テリフルノミド、フィンゴリモドまたはラキニモドとフマル酸ジメチルとの組み合わせを目的とする。
本発明は、処置を必要とするヒト患者においてMSを処置する方法であって、当該患者に、フマル酸ジメチルとテリフルノミド(またはそのプロドラッグであるレフルノミド)、フィンゴリモドまたはラキニモドの組み合わせの1回経口投与形(例えば錠剤またはカプセル剤)の併用治療剤を投与することを含む方法に関する。組み合わせ製剤は、単剤のみより有効であり、および/または、単剤のみより副作用が少なく、良好な耐容性を有し、および/または少ない頻度で投与し得る。
臨床試験は、0〜5のベースライン総合障害度評価尺度(EDDS)を有し、無作為化前12月間に少なくとも1回の再発があって先のMRIスキャニングで多発性硬化症と一致する病変を示すか、または、無作為化前6月以内に行ったMRIスキャンでGdE病変を示す、マクドナルド診断基準で診断された寛解再発型多発性硬化症患者を含む。無作為化前50日以内に再発した患者または先の再発から安定化していない患者は除外する。1年以内にT細胞またはT受容体ワクチン接種、全身リンパ系放射線照射または治療用モノクローナル抗体処置で処置された患者、無作為化前1年以内にミトキサントロンまたはシクロホスファミドで処置された患者も除外した。同様に、無作為化前6月以内にシクロスポリン、アザチオプリン、メトトレキサートまたは血漿交感で処置された患者も除外する。同様に、胃腸の疾患、例えば十二指腸潰瘍、胃炎、または膵臓の疾患の既往歴を有する患者も除外する。リンパ球減少症の患者、白血球細胞数が低い患者、またはベースラインで<60ml/分のクレアチニンクリアランス計算値を有する患者も除外する。
1.1: 単一調剤腸溶性コーティング錠の500mgの持続性放出DMFおよび6mgの即時放出テリフルノミドからなる組み合わせ錠剤;
1.2 :テリフルノミド6mg+プラセボDMF腸溶性コーティング錠;
1.3: 500mg用量のDMF+テリフルノミドプラセボ腸溶性コーティング錠;
1.4: プラセボDMF+プラセボテリフルノミド腸溶性コーティング錠。
2.1: 単一調剤腸溶性コーティング錠の500mg持続性放出DMFおよび即時放出0.3mgフィンゴリモドからなる組み合わせ錠剤;
2.2: フィンゴリモド0.3mg+プラセボDMF腸溶性コーティング錠;
2.3: 500mg用量のDMF+フィンゴリモドプラセボ腸溶性コーティング錠;
2.4: プラセボDMF+プラセボフィンゴリモド腸溶性コーティング錠。
3.1: 単一調剤腸溶性コーティング錠の500mgの持続性放出DMFおよび0.25mgの即時放出ラキニモドからなる組み合わせ錠剤;
3.2: ラキニモド0.25mg+プラセボDMF腸溶性コーティング錠;
3.3: 500mg用量のDMF+ラキニモドプラセボ腸溶性コーティング錠;
3.4: プラセボDMF+プラセボラキニモド腸溶性コーティング錠。
フィルムコートを有する浸食性マトリックスコアを含む腸溶性コーティング錠を、本発明に従ってフマル酸ジメチルとテリフルノミド(実施例4)、フマル酸ジメチルとフィンゴリモド(実施例5)、および、フマル酸ジメチルとラキニモド(実施例6)の組み合わせを製剤するために使用する。
** 理論上適用されたコーティング組成物、実際に適用されたコーティングは、約2重量%である。
Claims (1)
- 活性成分としてフマル酸ジメチルと、テリフルノミド、フィンゴリモドおよびラキニモドから選択される1種の薬物ならびに1種以上の薬学的に許容される添加物からなる、多発性硬化症の経口処置に適した医薬組成物。
Applications Claiming Priority (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP12179232.9 | 2012-08-03 | ||
EP12179232.9A EP2692343A1 (en) | 2012-08-03 | 2012-08-03 | Combination therapy for treatment of multiple sclerosis |
US201261712008P | 2012-10-10 | 2012-10-10 | |
EP12187939.9 | 2012-10-10 | ||
US61/712,008 | 2012-10-10 | ||
EP12187939.9A EP2692344A1 (en) | 2012-08-03 | 2012-10-10 | Combination therapy for treatment of Multiple sclerosis |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
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JP2015524803A Division JP2015523407A (ja) | 2012-08-03 | 2013-08-02 | 多発性硬化症を処置するための併用療法 |
Related Child Applications (1)
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JP2019206122A Division JP6884841B2 (ja) | 2012-08-03 | 2019-11-14 | 多発性硬化症を処置するための併用療法 |
Publications (1)
Publication Number | Publication Date |
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JP2018150375A true JP2018150375A (ja) | 2018-09-27 |
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Application Number | Title | Priority Date | Filing Date |
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JP2015524803A Pending JP2015523407A (ja) | 2012-08-03 | 2013-08-02 | 多発性硬化症を処置するための併用療法 |
JP2018107836A Pending JP2018150375A (ja) | 2012-08-03 | 2018-06-05 | 多発性硬化症を処置するための併用療法 |
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JP2015524803A Pending JP2015523407A (ja) | 2012-08-03 | 2013-08-02 | 多発性硬化症を処置するための併用療法 |
Country Status (20)
Country | Link |
---|---|
US (2) | US20150164849A1 (ja) |
EP (4) | EP2692343A1 (ja) |
JP (2) | JP2015523407A (ja) |
KR (3) | KR20210147083A (ja) |
CN (3) | CN113288891A (ja) |
AU (3) | AU2013298517A1 (ja) |
CA (2) | CA3107367A1 (ja) |
DK (1) | DK2879672T3 (ja) |
EA (1) | EA201590166A8 (ja) |
ES (1) | ES2674947T3 (ja) |
HK (1) | HK1211210A1 (ja) |
HR (1) | HRP20180939T1 (ja) |
HU (1) | HUE038382T2 (ja) |
LT (1) | LT2879672T (ja) |
PL (1) | PL2879672T3 (ja) |
PT (1) | PT2879672T (ja) |
RS (1) | RS57567B1 (ja) |
SI (1) | SI2879672T1 (ja) |
TR (1) | TR201808859T4 (ja) |
WO (1) | WO2014020156A1 (ja) |
Families Citing this family (17)
Publication number | Priority date | Publication date | Assignee | Title |
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DK2334378T3 (da) | 2008-08-19 | 2014-07-07 | Xenoport Inc | Prodrugs af methylhydrogenfumarat, farmaceutiske sammensætninger deraf og fremgangsmåder til anvendelse |
US9504679B2 (en) | 2011-12-19 | 2016-11-29 | Bjoern Colin Kahrs | Pharmaceutical compositions comprising glitazones and Nrf2 activators |
US20130158077A1 (en) | 2011-12-19 | 2013-06-20 | Ares Trading S.A. | Pharmaceutical compositions |
AU2013305684B2 (en) * | 2012-08-22 | 2016-11-24 | Xenoport, Inc. | Oral dosage forms of methyl hydrogen fumarate and prodrugs thereof |
US10945984B2 (en) | 2012-08-22 | 2021-03-16 | Arbor Pharmaceuticals, Llc | Methods of administering monomethyl fumarate and prodrugs thereof having reduced side effects |
WO2014160633A1 (en) | 2013-03-24 | 2014-10-02 | Xenoport, Inc. | Pharmaceutical compositions of dimethyl fumarate |
US9302977B2 (en) | 2013-06-07 | 2016-04-05 | Xenoport, Inc. | Method of making monomethyl fumarate |
WO2014205392A1 (en) | 2013-06-21 | 2014-12-24 | Xenoport, Inc. | Cocrystals of dimethyl fumarate |
TW201516020A (zh) | 2013-09-06 | 2015-05-01 | Xenoport Inc | (n,n-二乙基胺甲醯基)甲基(2e)丁-2-烯-1,4-二酸甲酯之晶形、合成方法及用途 |
US9999672B2 (en) | 2014-03-24 | 2018-06-19 | Xenoport, Inc. | Pharmaceutical compositions of fumaric acid esters |
MA40982A (fr) * | 2014-11-19 | 2017-09-26 | Biogen Ma Inc | Formulation de bille pharmaceutique comprenant du fumarate de diméthyle |
MA41139A (fr) | 2014-12-11 | 2017-10-17 | Actelion Pharmaceuticals Ltd | Combinaison pharmaceutique comportant un agoniste sélectif du récepteur sip1 |
JOP20190207A1 (ar) | 2017-03-14 | 2019-09-10 | Actelion Pharmaceuticals Ltd | تركيبة صيدلانية تشتمل على بونيسيمود |
US11446055B1 (en) | 2018-10-18 | 2022-09-20 | Lumoptik, Inc. | Light assisted needle placement system and method |
TR201820976A2 (tr) * | 2018-12-28 | 2020-07-21 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | Fi̇ngoli̇mod ve bi̇r spazmoli̇ti̇k i̇çeren farmasöti̇k kombi̇nasyonlar |
MX2022003010A (es) * | 2019-09-11 | 2022-06-02 | Novartis Ag | Tratamiento de la emr mediante cambio de terapia. |
EP4117785A4 (en) * | 2020-03-13 | 2024-04-17 | Marc J. Simard | METHODS OF TREATMENT OF MULTIPLE SCLEROSIS |
Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
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JP2009510137A (ja) * | 2005-10-07 | 2009-03-12 | アディテック・ファルマ・アクチボラゲット | フマル酸エステルを含む制御放出医薬組成物 |
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Publication number | Priority date | Publication date | Assignee | Title |
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US20080227847A1 (en) | 2005-07-07 | 2008-09-18 | Aditech Pharma Ab | Novel Salts of Fumaric Acid Monoalkylesters and Their Pharmaceutical Use |
PT2564839T (pt) | 2009-01-09 | 2016-07-14 | Forward Pharma As | Formulação farmacêutica compreendendo um ou mais ésteres de ácido fumárico numa matriz de erosão |
DK2533634T3 (en) | 2010-02-12 | 2016-01-25 | Biogen Ma Inc | NEURO PROTECTIVE demyelinating diseases |
US20130259856A1 (en) * | 2012-03-27 | 2013-10-03 | Teva Pharmaceutical Industries, Ltd. | Treatment of multiple sclerosis with combination of laquinimod and dimethyl fumarate |
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2012
- 2012-08-03 EP EP12179232.9A patent/EP2692343A1/en not_active Withdrawn
- 2012-10-10 EP EP12187939.9A patent/EP2692344A1/en not_active Withdrawn
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2013
- 2013-08-02 KR KR1020217038002A patent/KR20210147083A/ko not_active Application Discontinuation
- 2013-08-02 EP EP13745073.0A patent/EP2879672B1/en active Active
- 2013-08-02 SI SI201331068T patent/SI2879672T1/sl unknown
- 2013-08-02 EA EA201590166A patent/EA201590166A8/ru unknown
- 2013-08-02 US US14/419,031 patent/US20150164849A1/en not_active Abandoned
- 2013-08-02 CN CN202110575106.4A patent/CN113288891A/zh active Pending
- 2013-08-02 TR TR2018/08859T patent/TR201808859T4/tr unknown
- 2013-08-02 CN CN201710423062.7A patent/CN107669668A/zh active Pending
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