Buprenorphine/samidorphan | Wikipedia audio article
Channel: wikipedia tts
Date: 2018-10-29

This is an audio version of the Wikipedia Article:
Buprenorphine/samidorphan

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SUMMARY
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Buprenorphine/samidorphan (developmental code name ALKS-5461) is a combination drug formulation of buprenorphine and samidorphan acting as a κ-opioid receptor (KOR) antagonist which is under development by Alkermes as an adjunct to antidepressant therapy in treatment-resistant depression (TRD).Top level data from two Phase III trials was released in 2016; ALKS-5461 failed to meet its primary efficacy endpoints. On the basis of a third phase III study that did meet its primary efficacy endpoints, Alkermes initiated a rolling New Drug Application with the FDA. In late January 2018, Alkermes submitted a New Drug Application for ALKS-5461 to the FDA for the adjunctive treatment of major depressive disorder. A PDUFA date of 31 January 2019 has been set by the FDA for approval of ALKS-5461 (i.e., the FDA will review and approve or reject ALKS-5461 by this deadline).