JP2017515858A - Adhdの治療のためのダソトラリンに関する方法および組成物 - Google Patents
Adhdの治療のためのダソトラリンに関する方法および組成物 Download PDFInfo
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- JP2017515858A JP2017515858A JP2016567685A JP2016567685A JP2017515858A JP 2017515858 A JP2017515858 A JP 2017515858A JP 2016567685 A JP2016567685 A JP 2016567685A JP 2016567685 A JP2016567685 A JP 2016567685A JP 2017515858 A JP2017515858 A JP 2017515858A
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- dasotraline
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- adhd
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
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- 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
- A61K31/136—Amines having aromatic rings, e.g. ketamine, nortriptyline having the amino group directly attached to the aromatic ring, e.g. benzeneamine
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- A61K9/00—Medicinal preparations characterised by special physical form
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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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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Abstract
Description
本出願は、2014年5月13日に提出された米国仮出願番号第61/992,588号の優先権を主張する。米国仮出願番号第61/992,588号の全ての内容は、参照により本明細書に組み込まれる。
注意欠陥・多動性障害(ADHD)とは、子供および若者に影響を与えるよく知られた症状であり、また一部の者にとっては大人になっても継続する可能性がある。ある専門家によれば、ADHDは、学童期の子供の8%〜10%が発症すると考えられているが、国立精神衛生研究所(NIMH)によれば、3%〜5%の子供がADHDに罹患していると概算されている。多くの証拠から、約50%の子供はADHDを克服できないと示唆されている。正確な数値が如何なるものであっても、ADHDは、子供および大人の双方にとって深刻なメンタルヘルスの問題である。
便宜上、本明細書において「ダソトラリン(dasotraline)」として参照されるトランス 4-(3,4-ジクロロフェニル)-1,2,3,4-テトラヒドロ-1-ナフタレンアミンの(1R,4S)エナンチオマーは、非常に特殊な用量および用法にて、認識可能な乱用傾向を示さずに、ADHDの治療効果を提供することが判った。
ダソトラリン[(1R,4S)-4-(3,4-ジクロロフェニル)-1,2,3,4-テトラヒドロナフタレン-1-アミン]は、DNRI薬理効果を有する新規化合物である。ダソトラリンは、ヒトのDAトランスポーター(DAT;ドーパミンの取込みIC50 3 nM)およびNEトランスポーター(NET;ノルエピネフリンの取込みIC50 4 nM)の強力な阻害剤として作用し、かつヒトのセロトニントランスポーター(SERT;セロトニンの取込みIC50 15 nM)の弱い阻害剤としても作用する。
Claims (9)
- 経口投薬形態のダソトラリンを用いるADHDの治療方法であって、前記治療における改善が、1日1回投与して、かつ3週間測定した場合に、10 ng/mL〜18 ng/mLのダソトラリンの24時間-平均血清濃度を提供する経口投薬形態で投与することを特徴とする、治療方法。
- 前記経口投薬形態が、12 ng/mL〜16 ng/mLのダソトラリンの24時間-平均血清濃度を提供する、請求項1記載の方法。
- ADHDの治療が必要な対象に、錠剤またはカプセルの形態にて、最初の用量を、1日経口投与することにより治療を開始することを特徴とする、ADHDの治療方法であって、前記錠剤またはカプセルは、6〜8 mg のダソトラリンを含んでおり、前記治療が、6〜8 mgのダソトラリンを含む錠剤またはカプセルを、1日1回経口投与することにより継続される、方法。
- 前記経口投薬形態が、6、7または8 mgのダソトラリンを含有している、請求項3記載の方法
- 前記経口投薬形態が、8 mgのダソトラリンを含有している、請求項3記載の方法。
- 前記経口投薬形態が、6 mgのダソトラリンを含有している、請求項3記載の方法。
- 前記経口投薬形態が、8 mgのダソトラリンをその塩酸塩形態で含有している、請求項6記載の方法。
- 前記投薬形態が、9 mgのダソトラリン塩酸塩、および複数の医薬的に許容できる賦形剤を含んでいる、請求項3記載の方法。
- 前記投薬形態が、6.75 mgのダソトラリン塩酸塩、および複数の医薬的に許容できる賦形剤を含んでいる、請求項3記載の方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US201461992588P | 2014-05-13 | 2014-05-13 | |
US61/992,588 | 2014-05-13 | ||
PCT/US2015/030342 WO2015175514A1 (en) | 2014-05-13 | 2015-05-12 | Methods and compositions of dasotraline for treatment of adhd |
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JP2017515858A true JP2017515858A (ja) | 2017-06-15 |
JP2017515858A5 JP2017515858A5 (ja) | 2018-06-21 |
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CN (1) | CN106660936A (ja) |
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IL (1) | IL248846A0 (ja) |
MX (1) | MX2016014780A (ja) |
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JP2021512057A (ja) * | 2018-01-19 | 2021-05-13 | サノビオン ファーマシューティカルズ インクSunovion Pharmaceuticals Inc. | 経口製剤 |
US20210386689A1 (en) * | 2018-10-31 | 2021-12-16 | Sunovion Pharmaceuticals Inc. | Methods of treating central nervous system disorders |
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JP2013512921A (ja) * | 2009-12-04 | 2013-04-18 | スノビオン プハルマセウトイカルス インコーポレイテッド | トランスノルセルトラリンの製剤、塩、及び多形体、並びにその使用 |
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US4556676A (en) * | 1979-11-01 | 1985-12-03 | Pfizer Inc. | Antidepressant derivatives of trans-4-phenyl-1,2,3,4-tetrahydro-1-naphthalenamine |
US4981870A (en) * | 1989-03-07 | 1991-01-01 | Pfizer Inc. | Use of 4-phenyl-1,2,3,4-tetrahydro-1-naphthalenamine derivatives in the treatment of psychosis, inflammation and as immunosuppressants |
DK1542961T3 (da) * | 2002-09-16 | 2013-11-04 | Sepracor Inc | Trans-4-(3,4-dichlorphenyl)-1,2,3,4-tetrahydro-1-napthalenamin til anvendelse til behandling af cns-forstyrrelser |
CN100584818C (zh) * | 2002-09-16 | 2010-01-27 | 塞普拉科公司 | 用反式4-(3,4-二氯苯基)-1,2,3,4-四氢-1-萘胺及其甲酰胺治疗cns病症 |
CA2836066A1 (en) * | 2011-05-13 | 2012-11-22 | Dainippon Sumitomo Pharma Co., Ltd. | Treatment and management of cns disorders |
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- 2015-05-12 JP JP2016567685A patent/JP2017515858A/ja active Pending
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US20170266133A1 (en) | 2017-09-21 |
CA2948829A1 (en) | 2015-11-19 |
KR20170003677A (ko) | 2017-01-09 |
MX2016014780A (es) | 2017-07-25 |
IL248846A0 (en) | 2017-01-31 |
CN106660936A (zh) | 2017-05-10 |
EP3142999A4 (en) | 2017-12-27 |
WO2015175514A1 (en) | 2015-11-19 |
EP3142999A1 (en) | 2017-03-22 |
AU2015259337A1 (en) | 2016-12-08 |
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