JP2017502089A - 偏頭痛の処置 - Google Patents
偏頭痛の処置 Download PDFInfo
- Publication number
- JP2017502089A JP2017502089A JP2016563885A JP2016563885A JP2017502089A JP 2017502089 A JP2017502089 A JP 2017502089A JP 2016563885 A JP2016563885 A JP 2016563885A JP 2016563885 A JP2016563885 A JP 2016563885A JP 2017502089 A JP2017502089 A JP 2017502089A
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- JP
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- Prior art keywords
- prostaglandin
- migraine
- analog
- pharmaceutically acceptable
- acceptable salt
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- ISIJQEHRDSCQIU-UHFFFAOYSA-N tert-butyl 2,7-diazaspiro[4.5]decane-7-carboxylate Chemical compound C1N(C(=O)OC(C)(C)C)CCCC11CNCC1 ISIJQEHRDSCQIU-UHFFFAOYSA-N 0.000 description 1
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/557—Eicosanoids, e.g. leukotrienes or prostaglandins
- A61K31/5575—Eicosanoids, e.g. leukotrienes or prostaglandins having a cyclopentane, e.g. prostaglandin E2, prostaglandin F2-alpha
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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
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
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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
- A61K9/0048—Eye, e.g. artificial tears
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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
- A61P25/06—Antimigraine agents
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Abstract
Description
本出願は、米国仮出願番号61/925,676、2014年1月10日出願の出願日の利益を主張し、その全内容が本明細書に参照として組み込まれる。
本発明のこれらのおよび他の側面が、以下に詳述される。
局所的に投与するとは、皮膚へ、毛髪へ、爪へまたは目の表面、結膜、直腸、鼻、咽喉もしくは肺、または口腔などの粘膜へなど、表皮へ投与することを意味する。
本発明の処方に用いてよい保存料の例は、これに限定するものではないが、静菌化合物および様々なアルコール、ソルビン酸およびその塩および誘導体、エチレンジアミン、モノチオグリセロール、およびチメロサールを含む他の局所投与に好適な保存料を含む。
本発明の処方に用いてよい抗酸化剤の例は、例えばアスコルビルパルミタートなどのアスコルビン酸およびその誘導体、ならびにブチルヒドロキシアニソール、ブチルヒドロキシトルエン、亜硫酸水素ナトリウム、ピロ亜硫酸ナトリウムなどを含む。
本薬剤処方に含んでよい他の補助剤は、担体、粘着付与剤、色素、染料、および処方の機械的性質または粘着性に悪く影響しない他の添加剤を含む。
上述のとおり、本発明のいかなる理論に拘束されることを望むものではないが、非常に低い血漿レベルのプロスタグランジンF2αアナログ濃度の供給が所望の結果を生み出していると考えられる。投与および血漿レベルは、かかるアナログで緑内障を処置するのに有用であることが見出されたものと同一であり得る。
53歳の男性の対象を、1日1回夜に両眼に各1滴のトラボプロスト0.0004%の眼球投与で処置した。対象は処置開始後30日間に偏頭痛がなかったと報告した。
古典的な誘因(チーズ、赤ワイン、アルコール、グルタミン酸ナトリウム、エビ、マッシュルーム、および睡眠不足)に直接的に関する偏頭痛の履歴(毎週1〜3回)のある63歳の健康な男性に、毎日1滴(約0.05ml)のプロスタグランジン、LUMIGAN(登録商標)(ビマトプロスト眼科用溶液)、を片手の4本の指の爪上皮領域に局所的に投与した。1ヶ月後、頭痛の頻度は、典型的パターンである毎週1〜3回から、頭痛のない時間幅が2〜3週間に延長されるように減少した。
その後LUMIGAN(登録商標)処置を、4本の指の爪への毎日局所投与で4ヶ月間再開した。上記第1の処置で言及したように、1ヶ月後、頭痛の頻度における同様の減少が観察された。処置の中止により、1ヶ月後、頭痛の頻度は基底レベル(毎週1〜3回)に戻った。
次の3ヶ月間は、投与を3本の指の爪に少なくしたが、治療的効果に損失はなかった。
さらに、1ヶ月間用量を2本の指の爪に少なくしたが、再度頭痛頻度における変化はなかった。処置を終了した。
そこで2ヶ月後、処置を3本の指の爪への局所投与で再開した。処置再開後最初の2週間以内に、頭痛の頻度の減少が観察された。
3ヶ月後、用量を1本の指の爪への毎日の局所投与に少なくした。偏頭痛頻度は、用量の低減から2週間以内に、処置前の基底レベル(毎週1〜3回)に戻った。
1本の指の爪のみへの投与で1ヶ月経過後、用量を2本の指の爪への毎日投与に増加させた。頭痛頻度は2週間以内に低減した。
2本の指の爪への毎日投与をさらに2ヶ月維持し、頭痛頻度は引き続き低減していた。
毎日偏頭痛を経験する履歴を有する32歳の女性に、片手の4本の指の爪にLUMIGAN(登録商標)を各1滴滴下して投与する処置を開始した。液滴を爪床の上に5分間維持した。2週間以内に、彼女はほとんど頭痛を有しなくなり、彼女が時折頭痛を有する時も、処置前と比べると穏やかなものであった。
処置を中止した後、毎日の頭痛が戻った。
複数の頭痛の専門家に見てもらい、全ての誘因食品を避けているものの頭痛頻度または強度に低減がない、40年間の偏頭痛の履歴を有する58歳の女性。約45日間の、片手の4本の指の爪にLUMIGAN(登録商標)を各1滴、1日1回の投与を行い、彼女の頭痛頻度および重篤度は減少した。
処置を中止した後、頭痛の頻度および重篤度は、処置前のレベルに戻った。
複数の治療に対して難治性の重篤な偏頭痛の履歴を有する54歳の男性に、TRAVATAN Z(登録商標)(トラボプロスト眼科用溶液)による片眼への毎日局所投与の処置を開始した。1ヶ月後、偏頭痛は完全になくなった。
偏頭痛の履歴(毎週1回)を有する64歳の女性に、プロスタグランジン、XALATAN(登録商標)(ラタノプロスト眼科用溶液)の毎日局所投与処置を、毎日両眼に開始した。6ヶ月の処置後、偏頭痛の頻度は6ヶ月に1回に低減し、重篤度もより穏やかになった。
毎週の偏頭痛の履歴を有する47歳男性に、片手の3本の指の爪へのLUMIGAN(登録商標)の各1滴の適用を開始した。2週間後、偏頭痛の頻度および重篤度は減少し、処置の3ヶ月間維持された。
Claims (9)
- それを必要とする対象における偏頭痛を処置する方法であって、該方法が、プロスタグランジンF2αアナログまたはその薬学的に許容可能な塩を含む組成物を、偏頭痛を処置するのに有効な量で、対象に局所的に投与することを含む、前記方法。
- プロスタグランジンF2αアナログまたはその薬学的に許容可能な塩が、予防的に投与される、請求項1に記載の方法。
- プロスタグランジンF2αアナログまたはその薬学的に許容可能な塩が、治療的に投与される、請求項1に記載の方法。
- プロスタグランジンF2αアナログまたはその薬学的に許容可能な塩が、対象の爪に投与される、請求項1に記載の方法。
- プロスタグランジンF2αアナログまたはその薬学的に許容可能な塩が、対象の目に投与される、請求項1に記載の方法。
- プロスタグランジンF2αアナログまたはその薬学的に許容可能な塩が、対象の皮膚または粘膜に投与される、請求項1に記載の方法。
- プロスタグランジンF2αアナログが、ラタノプロスト、イソプロピルウノプロストン、ビマトプロスト、トラボプロストおよびタフルプロストからなる群から選択されるもの、またはその薬学的に許容可能な塩である、請求項1に記載の方法。
- プロスタグランジンF2αアナログまたはその薬学的に許容可能な塩が、ビマトプロストまたはその薬学的に許容可能な塩である、請求項1に記載の方法。
- プロスタグランジンF2αアナログまたはその薬学的に許容可能な塩が、ビマトプロスト、トラボプロストもしくはラタノプロスト、またはその薬学的に許容可能な塩である、請求項1に記載の方法。
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CN115500876A (zh) * | 2019-12-27 | 2022-12-23 | 四川大学华西医院 | 治疗卵圆孔未闭的装置在制备治疗癫痫和/或偏头痛的装置中的用途 |
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