JP2018502924A - 静脈内バクロフェン製剤および治療方法 - Google Patents
静脈内バクロフェン製剤および治療方法 Download PDFInfo
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- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 11
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- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims description 3
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- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 3
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- OQKFGIANPCRSSK-UHFFFAOYSA-N azanium;methanol;acetate Chemical compound [NH4+].OC.CC([O-])=O OQKFGIANPCRSSK-UHFFFAOYSA-N 0.000 description 1
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- 229960004002 levetiracetam Drugs 0.000 description 1
- HPHUVLMMVZITSG-ZCFIWIBFSA-N levetiracetam Chemical compound CC[C@H](C(N)=O)N1CCCC1=O HPHUVLMMVZITSG-ZCFIWIBFSA-N 0.000 description 1
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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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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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
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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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
- A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
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Abstract
Description
本出願は、2015年1月15日に出願された、米国仮特許出願第62/103,902号の優先権を主張し、その内容は、参照により本明細書によって本明細書に完全に記載されているが如く組み込まれている。
Claims (26)
- 医学的変動の期間中に対象をバクロフェンで一時的に治療する方法であって、
(a)前記対象へのバクロフェンの経口または髄腔内投与を中断することと、
(b)約2.0mg/mLまでの濃度のバクロフェンを含む溶液の治療上有効量であるボーラス静脈内用量を約5分から約60分の時間をかけて前記対象に投与することと、
(c)バクロフェンの経口または髄腔内投与が再開されるまで約6から8時間毎に、バクロフェンの前記ボーラス静脈内用量の投与を繰り返すことと、
(d)バクロフェンの前記ボーラス静脈内用量の投与を中断することと、
(e)バクロフェンの経口または髄腔内投与を再開することと、
を含む方法。 - 前記医学的変動が、髄腔内のハードウェアの故障、髄腔内のハードウェアを除去、補充、もしくは交換する必要性、予定されたもしくは予定外の外科的処置、外傷、イレウス、腸閉塞、嘔吐、下痢、消化管吸収不良、発作、卒中、クモ膜下出血、または患者のノンコンプライアンスのうちの少なくとも1つを含む、請求項1に記載の方法。
- 前記溶液が、約0.5〜2.0mg/mLの濃度のバクロフェンを含む、請求項1に記載の方法。
- 前記溶液が、約0.5〜1.0mg/mLの濃度のバクロフェンを含む、請求項1に記載の方法。
- 前記対象がバクロフェン離脱症状を経験している、請求項1に記載の方法。
- 経口バクロフェンで現在治療されている対象にバクロフェンを治療有効量で静脈内投与する方法であって、
(a)前記対象へのバクロフェンの経口投与を中断することと、
(b)前記対象にバクロフェンの前記投与量の約75%を含む溶液のボーラス静脈内用量を約5分から約60分の時間をかけて投与することと、
(c)バクロフェンの経口投与が再開されるまで約6から8時間毎に、バクロフェンの前記ボーラス静脈内用量の投与を繰り返すことと、
(d)静脈内バクロフェンの投与を中断することと、
(e)バクロフェンの経口投与を再開することと、
を含む方法。 - 医学的変動の期間中にステップ(a)〜(d)を行うことをさらに含み、医学的変動が、髄腔内のハードウェアの故障、髄腔内のハードウェアを除去、補充、もしくは交換する必要性、予定されたもしくは予定外の外科的処置、外傷、イレウス、腸閉塞、嘔吐、下痢、消化管吸収不良、発作、卒中、クモ膜下出血、または患者のノンコンプライアンスのうちの少なくとも1つを含む、請求項6に記載の方法。
- 前記溶液が、約0.5〜2.0mg/mLの濃度のバクロフェンを含む、請求項6に記載の方法。
- 前記溶液が、約0.5〜1.0mg/mLの濃度のバクロフェンを含む、請求項6に記載の方法。
- 医学的変動の期間中に対象をバクロフェンで一時的に治療する方法であって、
(a)対象へのバクロフェンの経口または髄腔内投与を中断することと、
(b)約2.0mg/mL以下の濃度のバクロフェンを含む治療有効量の溶液の約24時間にわたって持続的静脈内注入を開始することと、
(c)前記注入を、バクロフェンの経口または髄腔内投与が再開されるまで継続することと、
(d)持続的静脈内注入を中断することと、
(e)バクロフェンの経口または髄腔内投与を再開することと、
を含む方法。 - 前記医学的変動が、髄腔内ハードウェアの故障、髄腔内ハードウェアを除去、補充、もしくは交換する必要性、予定されたもしくは予定外の外科的処置、外傷、イレウス、腸閉塞、嘔吐、下痢、消化管吸収不良、発作、卒中、クモ膜下出血、または患者のノンコンプライアンスのうちの少なくとも1つを含む、請求項10に記載の方法。
- 前記溶液が、約0.5〜2.0mg/mLの濃度のバクロフェンを含む、請求項10に記載の方法。
- 前記溶液が、約0.5〜1.0mg/mLの濃度のバクロフェンを含む、請求項10に記載の方法。
- 前記対象がバクロフェン離脱症状を経験している、請求項10に記載の方法。
- 経口バクロフェンで現在治療されている対象にバクロフェンを治療有効量で静脈内投与する方法であって、
(a)前記対象へのバクロフェンの経口投与を中断することと、
(b)前記対象にバクロフェンの前記投与量の約75%を含む溶液の持続的静脈内注入を約24時間の時間をかけて投与することと、
(c)前記持続的静脈内注入の投与を、バクロフェンの経口投与が再開されるまで約24時間毎に繰り返すことと、
(d)前記持続的静脈内注入を中断することと、
(e)バクロフェンの経口投与を再開することと、
を含む方法。 - 医学的変動の期間中にステップ(a)〜(d)を行うことをさらに含み、医学的変動が、髄腔内ハードウェアの故障、髄腔内ハードウェアを除去、補充、もしくは交換する必要性、予定されたもしくは予定外の外科的処置、外傷、イレウス、腸閉塞、嘔吐、下痢、消化管吸収不良、発作、卒中、クモ膜下出血、または患者のノンコンプライアンスのうちの少なくとも1つを含む、請求項15に記載の方法。
- 前記溶液が、約0.5〜2.0mg/mLの濃度のバクロフェンを含む、請求項15に記載の方法。
- 前記溶液が、約0.5〜1.0mg/mLの濃度のバクロフェンを含む、請求項15に記載の方法。
- バクロフェンの経口用量をバクロフェンの静脈内用量に変換する方法であって、
(a)前記経口用量を決定することと、
(b)前記経口用量に約0.45と約1.0との間の値を乗算して静脈内用量を決定することと、
を含む方法。 - ステップ(b)が、前記経口用量に約0.6と約0.9との間の値を乗算して静脈内用量を決定することを含む、請求項19に記載の方法。
- ステップ(b)が、前記静脈内用量を決定するために、前記経口用量に約0.7と約0.8との間の値を乗算して前記静脈内用量を決定することを含む、請求項20に記載の方法。
- 生理食塩水、ブドウ糖液、乳酸リンゲル液、またはそれらの任意の組み合わせのうちの少なくとも1種の中に溶解された約2.0mg/mLまでの効果的な治療量のバクロフェンを含む医薬溶液であって、
対象に静脈内投与されるように適合されている医薬溶液。 - 抗痙攣薬、鎮痙薬、抗コリン薬、または抗生物質薬のうちの少なくとも1種をさらに含む、請求項22に記載の溶液。
- 無菌である、請求項22に記載の溶液。
- 約0.5〜2.0mg/mLの濃度のバクロフェンを含む、請求項22に記載の溶液。
- 約0.5〜1.0mg/mLの濃度のバクロフェンを含む、請求項22に記載の溶液。
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US201562103902P | 2015-01-15 | 2015-01-15 | |
US62/103,902 | 2015-01-15 | ||
PCT/US2016/013672 WO2016115504A1 (en) | 2015-01-15 | 2016-01-15 | Intravenous baclofen formulations and treatment methods |
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EP (1) | EP3244884A4 (ja) |
JP (1) | JP2018502924A (ja) |
CA (1) | CA2974091A1 (ja) |
MX (1) | MX2017009313A (ja) |
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RU2018118617A (ru) * | 2015-10-21 | 2019-11-21 | АЛЛЭЙСИС, ЭлЭлСи | Баклофен для внутривенного введения и способы лечения |
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US7824697B2 (en) * | 2004-07-12 | 2010-11-02 | Board Of Regents, The University Of Texas System | High concentration baclofen preparations |
CA2670116C (en) * | 2006-11-22 | 2015-03-10 | Seaside Therapeutics, Llc | Methods of treating mental retardation, down's syndrome, fragile x syndrome and autism |
US9180108B2 (en) * | 2011-10-27 | 2015-11-10 | Medtronic, Inc. | Baclofen formulations and methods for making same |
EP2854774A4 (en) * | 2012-06-01 | 2015-11-18 | Lynn Health Science Inst Inc | METHODS OF TREATING INSOMNIA |
EP3244884A4 (en) | 2015-01-15 | 2018-07-25 | Allaysis, LLC | Intravenous baclofen formulations and treatment methods |
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2016
- 2016-01-15 EP EP16737994.0A patent/EP3244884A4/en not_active Withdrawn
- 2016-01-15 MX MX2017009313A patent/MX2017009313A/es unknown
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- 2016-01-15 US US14/997,135 patent/US10350183B2/en active Active
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2023
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CA2974091A1 (en) | 2016-07-21 |
US20230248679A1 (en) | 2023-08-10 |
US20210228520A1 (en) | 2021-07-29 |
US20160213631A1 (en) | 2016-07-28 |
US20190388373A1 (en) | 2019-12-26 |
EP3244884A4 (en) | 2018-07-25 |
WO2016115504A1 (en) | 2016-07-21 |
US10350183B2 (en) | 2019-07-16 |
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