JP2017528517A - 多汗症を治療するための方法 - Google Patents
多汗症を治療するための方法 Download PDFInfo
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- JP2017528517A JP2017528517A JP2017529596A JP2017529596A JP2017528517A JP 2017528517 A JP2017528517 A JP 2017528517A JP 2017529596 A JP2017529596 A JP 2017529596A JP 2017529596 A JP2017529596 A JP 2017529596A JP 2017528517 A JP2017528517 A JP 2017528517A
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- Prior art keywords
- hyperhidrosis
- dexmecamylamine
- mecamylamine
- pharmaceutically acceptable
- acceptable salt
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- 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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Abstract
Description
[実施例1]
原発性多汗症と関連した症状の改善のためのTC-5214 (0.1〜2mg、1日1回)。
多汗症は、汗腺が過活動となる医学的状態であり、また原発性多汗症(標的とする適応)は、別の医学的状態又は薬物治療により引き起こされた(続発性多汗症)のではない過剰発汗を意味する。TC-5214は、原発性発汗と関連した汗腺を神経支配する交感神経のコリン作動性線維の過活動を阻害し得る。有効性は、TC-5124を、約0.1〜約2mgで1日1回経口投与すると認められ得る。
原発性多汗症及び過活動性膀胱の比較
本明細書でこれまでに記載したように、過活動性膀胱(OAB)の治療のための、デクスメカミラミン(TC-5214)の安全性、忍容性、及び有効性を評価する臨床試験が実施された。当該試験には、3週間又は5週間スクリーニング期間、その後2週間のフォローアップ期間を伴う12週間の治療期間が設けられ、治療期間中に、患者は、2:1:1:1 (プラセボ、低用量、中用量、高用量)の比でランダム化され、3用量のデクスメカミラミン又はプラセボのうちのいずれか1つを1日2回投与された。過活動性膀胱を有する対象、合計768名を、試験の二重盲検治療期間にランダム化した。トライアルでは、高用量のTC-5214は共主要評価項目について様々な結果を示し、12週間の治療後、24時間当たりの排尿頻度について統計的に有意な低下(p=0.033)、及び尿失禁のエピソードについて、統計的有意性にはいたらない改善(p=0.379)をもたらした。これらの結果により、Targacept社は、OABにおけるTC-5214の更なる開発を中止した。このトライアルでは、TC-5214は、一般的に安全であり、良好に忍容されると考えられた。高用量群において、プラセボ補正後、15.1%の便秘率、及び5.9%の尿路感染症率が認められた。国際公開第2013/142162 A1号として公表されたPCT出願番号PCT/US第2013/030640号も参照。
観察された特定の薬理学的反応は、特定の塩形態を含む、選択された特定の活性化合物、又は医薬担体の有無、並びに処方物の種類及び採用された投与法に従い、これらに応じて変化し得、結果におけるそのような予想される変化又は差異は、本発明の実践によって検討される。
Claims (12)
- 多汗症を有する対象に、エキソ-R-メカミラミンを実質的に含まない、治療有効量のデクスメカミラミン又はその薬学的に許容される塩を投与することを含む、多汗症を治療する方法。
- 多汗症を有する対象に、エキソ-R-メカミラミンを実質的に含まないデクスメカミラミン又はその薬学的に許容される塩を、約0.1mg〜約2.0mgの量で1日1回経口投与することを含む、多汗症を治療する方法。
- デクスメカミラミン又はその薬学的に許容される塩が、約0.2mgの量で1日1回経口投与される、請求項2に記載の方法。
- デクスメカミラミン又はその薬学的に許容される塩が、約0.5mgの量で1日1回経口投与される、請求項2に記載の方法。
- デクスメカミラミン又はその薬学的に許容される塩が、約1.0mgの量で1日1回経口投与される、請求項2に記載の方法。
- デクスメカミラミン又はその薬学的に許容される塩が、約2.0mgの量で1日1回経口投与される、請求項2に記載の方法。
- デクスメカミラミン又はその薬学的に許容される塩が、錠剤の形態で経口投与される、請求項2に記載の方法。
- 多汗症を治療する方法であって、多汗症を有する対象に、エキソ-R-メカミラミンを実質的に含まないデクスメカミラミン又はその薬学的に許容される塩を、約0.1mg〜約2.0mgの量で1日1回経口投与することを含み、デクスメカミラミンの投与が、少なくとも1つの場所において患者の発汗に1以上の多汗症重症度評価スケール変化で影響を及ぼすのに十分である方法。
- デクスメカミラミンの投与が、少なくとも2つの場所において患者の発汗にそれぞれの場所において0.5以上のHDSS変化で影響を及ぼすのに十分である、請求項8に記載の方法。
- 場所が、腋窩、掌蹠、顔面/頭皮、又は全身から選択される、請求項8又は9に記載の方法。
- 多汗症が原発性多汗症である、請求項1から10に記載の方法。
- 対象がヒトである、請求項1〜11に記載の方法。
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US201462040477P | 2014-08-22 | 2014-08-22 | |
US62/040,477 | 2014-08-22 | ||
PCT/US2015/046055 WO2016028985A2 (en) | 2014-08-22 | 2015-08-20 | Method for treating hyperhidrosis |
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CA2393442A1 (en) | 1998-12-16 | 2000-06-22 | University Of South Florida | Exo-r-mecamylamine formulation and use in treatment |
WO2013142162A1 (en) | 2012-03-23 | 2013-09-26 | Targacept, Inc. | Method of treating bladder disorders |
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US10507190B2 (en) | 2019-12-17 |
US20180369168A1 (en) | 2018-12-27 |
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