JP2017502996A - 絶食条件下でのタシメルテオンの投与 - Google Patents
絶食条件下でのタシメルテオンの投与 Download PDFInfo
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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
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/34—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
- A61K31/343—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
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- 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
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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
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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
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- 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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Abstract
Description
本出願は、2014年1月14日付で出願された同時係属出願である米国特許仮出願番号第61/927,465号、及び2014年10月10日付で出願された米国特許出願番号第14/511,669号の優先権を主張するものであり、これらの出願が含むすべてがここに記載されているものとして、参照することにより本明細書に組み込まれる。
絶食条件下で有効用量のタシメルテオンを経口投与することを含む、ヒト患者にタシメルテオンを投与する方法、
食物無しにタシメルテオンを投与しなければならないことを患者に指示することを含む、ヒト患者にタシメルテオンを投与する方法、
タシメルテオンで治療されているヒト患者におけるTmaxを短縮する方法であって、前記方法が絶食条件下で有効用量のタシメルテオンを経口投与することを含む方法、
タシメルテオンを絶食条件下で服用しなければならないことを、例えば、タシメルテオンのカプセル剤を含む容器と共に包装される印刷された処方情報にかかる指示を含むことにより、調剤者、患者、及び/又は保険業者に通知することを含む、タシメルテオンを市販又は販売する方法を含む。
絶食条件は投与の前、少なくとも1/2時間は食物を絶つことを含み、
絶食条件が投与の前、少なくとも1時間は食物を絶つことを含み、
絶食条件は投与の前、少なくとも1.5時間は食物を絶つことを含み、
絶食条件は投与の前、少なくとも2時間は食物を絶つことを含み、
絶食条件は投与の前、少なくとも2.5時間は食物を絶つことを含み、又は
絶食条件は投与の前、3時間は食物を絶つことを含む。
タシメルテオンの用量は20mg/日であり、
患者は概日リズム障害又は睡眠障害に対して治療され、及び/又は
患者は非24時間型障害に対して治療される。
「タシメルテオンのピーク濃度(Tmax)は、絶食経口投与のおよそ0.5時間〜3時間に生じる。高脂肪食と共に投与された場合、タシメルテオンのCmaxは絶食状態で与えられた場合よりも44%低く、メディアンTmaxはおよそ1.75時間遅延した。したがって、HETLIOZは食物無しに服用されなければならない。」
が挙げられる。
Claims (14)
- 絶食条件下で有効用量のタシメルテオンを経口投与することを含む、ヒト患者にタシメルテオンを投与する方法。
- 前記絶食条件が食物無しにタシメルテオンを投与することを含み、
前記絶食条件が投与の前、少なくとも1/2時間は食物を絶つことを含み、
前記絶食条件が投与の前、少なくとも1時間は食物を絶つことを含み、
前記絶食条件が投与の前、少なくとも1.5時間は食物を絶つことを含み、
前記絶食条件が投与の前、少なくとも2時間は食物を絶つことを含み、
前記絶食条件が投与の前、少なくとも2.5時間は食物を絶つことを含み、又は
前記絶食条件が投与の前、3時間は食物を絶つことを含む、
請求項1に記載の方法。 - 前記タシメルテオンが摂食条件下で投与されるか又は絶食条件下で投与されるかにかかわらず、前記タシメルテオンのAUCをほぼ同じとしながら、Cmaxを低下させる、請求項1に記載の方法。
- 前記タシメルテオンの有効用量が20mg/日である、請求項1に記載の方法。
- 前記有効用量が概日リズム障害又は睡眠障害を治療するのに有効である、請求項1に記載の方法。
- 前記有効用量が非24時間型障害を治療するのに有効である、請求項1に記載の方法。
- タシメルテオンを食物無しに服用することを患者に指示することを含む、ヒト患者にタシメルテオンを投与する方法。
- 食物無しにタシメルテオンを服用することが、食物無しにタシメルテオンを服用することを含み、
食物無しにタシメルテオンを服用することが、投与の前、少なくとも1/2時間は食物を絶つことを含み、
食物無しにタシメルテオンを服用することが、投与の前、少なくとも1時間は食物を絶つことを含み、
食物無しにタシメルテオンを服用することが、投与の前、少なくとも1.5時間は食物を絶つことを含み、
食物無しにタシメルテオンを服用することが、投与の前、少なくとも2時間は食物を絶つことを含み、
食物無しにタシメルテオンを服用することが、投与の前、少なくとも2.5時間は食物を絶つことを含み、又は
食物無しにタシメルテオンを服用することが、投与の前、3時間は食物を絶つことを含む、
請求項7に記載の方法。 - タシメルテオンで治療されているヒト患者におけるTmaxを短縮する方法であって、前記方法が絶食条件下で有効用量のタシメルテオンを経口投与することを含む、方法。
- 前記絶食条件が食物無しにタシメルテオンを投与することを含み、
前記絶食条件が投与の前、少なくとも1/2時間は食物を絶つことを含み、
前記絶食条件が投与の前、少なくとも1時間は食物を絶つことを含み、
前記絶食条件が投与の前、少なくとも1時間〜1/2時間は食物を絶つことを含み、
前記絶食条件が投与の前、少なくとも2時間は食物を絶つことを含み、
前記絶食条件が投与の前、少なくとも2時間〜1/2時間は食物を絶つことを含み、又は
前記絶食条件が投与の前、3時間は食物を絶つことを含む、
請求項9に記載の方法。 - 前記タシメルテオンが摂食条件下で投与されるか又は絶食条件下で投与されるかにかかわらず、前記タシメルテオンのAUCをほぼ同じとしながら、Cmaxを低下させる、請求項9に記載の方法。
- 前記タシメルテオンの有効用量が20mg/日である、請求項9に記載の方法。
- 前記有効用量が概日リズム障害又は睡眠障害を治療するのに有効である、請求項9に記載の方法。
- 前記有効用量が非24時間型障害を治療するのに有効である、請求項9に記載の方法。
Priority Applications (2)
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JP2021047935A JP2021102634A (ja) | 2014-01-14 | 2021-03-22 | 絶食条件下でのタシメルテオンの投与 |
JP2022206745A JP2023024704A (ja) | 2014-01-14 | 2022-12-23 | 絶食条件下でのタシメルテオンの投与 |
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US201461927465P | 2014-01-14 | 2014-01-14 | |
US61/927,465 | 2014-01-14 | ||
US14/511,669 | 2014-10-10 | ||
US14/511,669 US10376487B2 (en) | 2013-11-12 | 2014-10-10 | Method of treatment |
PCT/US2015/010410 WO2015108728A1 (en) | 2014-01-14 | 2015-01-07 | Administration of tasimelteon under fasted conditions |
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JP2021047935A Division JP2021102634A (ja) | 2014-01-14 | 2021-03-22 | 絶食条件下でのタシメルテオンの投与 |
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JP2017502996A true JP2017502996A (ja) | 2017-01-26 |
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JP2016546950A Pending JP2017502996A (ja) | 2014-01-14 | 2015-01-07 | 絶食条件下でのタシメルテオンの投与 |
JP2021047935A Pending JP2021102634A (ja) | 2014-01-14 | 2021-03-22 | 絶食条件下でのタシメルテオンの投与 |
JP2022206745A Pending JP2023024704A (ja) | 2014-01-14 | 2022-12-23 | 絶食条件下でのタシメルテオンの投与 |
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JP2021047935A Pending JP2021102634A (ja) | 2014-01-14 | 2021-03-22 | 絶食条件下でのタシメルテオンの投与 |
JP2022206745A Pending JP2023024704A (ja) | 2014-01-14 | 2022-12-23 | 絶食条件下でのタシメルテオンの投与 |
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US (4) | US10376487B2 (ja) |
EP (1) | EP3094322B1 (ja) |
JP (3) | JP2017502996A (ja) |
KR (3) | KR101970050B1 (ja) |
CN (2) | CN116115551A (ja) |
AU (3) | AU2015206797A1 (ja) |
CA (2) | CA3091827A1 (ja) |
CL (1) | CL2016001794A1 (ja) |
DK (1) | DK3094322T3 (ja) |
ES (1) | ES2805451T3 (ja) |
HK (1) | HK1231404A1 (ja) |
HR (1) | HRP20201069T1 (ja) |
HU (1) | HUE051244T2 (ja) |
IL (1) | IL246676B (ja) |
MX (1) | MX2016009231A (ja) |
NZ (1) | NZ722254A (ja) |
PT (1) | PT3094322T (ja) |
SI (1) | SI3094322T1 (ja) |
WO (1) | WO2015108728A1 (ja) |
ZA (1) | ZA201605103B (ja) |
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US11918557B2 (en) | 2012-01-26 | 2024-03-05 | Vanda Pharmaceuticals Inc. | Treatment of circadian rhythm disorders |
US10376487B2 (en) | 2013-11-12 | 2019-08-13 | Vanda Pharmaceuticals Inc. | Method of treatment |
US11090285B2 (en) | 2013-11-12 | 2021-08-17 | Vanda Pharmaceuticals Inc | Treatment of circadian rhythm disorders |
KR20240015729A (ko) | 2014-09-02 | 2024-02-05 | 반다 파마슈티칼즈, 인코퍼레이티드. | 스미스 마제니스 증후군을 치료하기 위한 타시멜테온 |
ES2965488T3 (es) | 2017-08-02 | 2024-04-15 | Vanda Pharmaceuticals Inc | Uso de tasimelteón para el tratamiento de trastornos afectivos en pacientes mayoritariamente negroafricanos |
CN113365618A (zh) * | 2018-09-12 | 2021-09-07 | 万带兰制药公司 | 改善睡眠或睡醒后表现 |
EP4072542A1 (en) | 2019-12-13 | 2022-10-19 | Vanda Pharmaceuticals Inc. | Liquid tasimelteon formulations and methods of use thereof |
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