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翻訳と辞書　辞書検索 [ 開発暫定版 ] スポンサード リンク ALKS-5461 ： ウィキペディア英語版 ALKS-5461 __NOTOC__ ALKS-5461 is a combination drug formulation of buprenorphine and samidorphan which is under development by Alkermes as an adjunct to antidepressant therapy in treatment-resistant depression (TRD).〔(【引用サイトリンク】 author = Alkermes )〕〔(【引用サイトリンク】 author = Alkermes )〕 It is also under development by Alkermes as a treatment for cocaine dependence, which is being funded by a grant from the National Institute on Drug Abuse (NIDA).〔(【引用サイトリンク】 author = Reuters )〕 ==Developmental progress== Following very positive phase II trial results, ALKS-5461 was granted Fast Track Designation by the Food and Drug Administration (FDA) for TRD in October 2013.〔(【引用サイトリンク】 author = PR Newswire )〕〔(【引用サイトリンク】 author = Business Wire )〕 During June and July 2014, three major phase III clinical trials were initiated in the United States to evaluate core efficacy for the use of ALKS-5461 as an adjunctive treatment for patients who have had an inadequate treatment response to antidepressant monotherapy with an agent such as a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).〔〔〔(【引用サイトリンク】 author = Digital Journal )〕 Results of these trials are expected in 2016.〔〔 In addition to these trials, nine smaller supplementary studies will also be conducted, and will together conclude phase III research.〔 In January 2015, Alkermes announced positive results from the first completed phase III study.〔(【引用サイトリンク】 author = Alkermes )〕 Alkermes has expressed its intent to submit a New Drug Application (NDA) to the FDA for the approval of adjunctive ALKS-5461 for the indication of TRD once phase III research has been completed.〔 Assuming positive phase III trial results and NDA acceptance, initial sales of ALKS-5461 are forecast for 2016, with $25 million in sales estimated for that year and $350 million in total sales anticipated by 2019. Alkermes is looking to out-license ALKS-5461.〔 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「ALKS-5461」の詳細全文を読む スポンサード リンク 翻訳と辞書 : 翻訳のためのインターネットリソース Copyright(C) kotoba.ne.jp 1997-2016. All Rights Reserved.