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ALKS 5461 Approval Status

FDA Approved: No
Brand name: ALKS 5461
Generic name: buprenorphine and samidorphan
Company: Alkermes, Inc.
Treatment for: Depression, Major Depressive Disorder

ALKS 5461 (buprenorphine and samidorphan) is a novel opioid modulator, combining a partial opioid agonist with an opioid antagonist to rebalance brain function in patients with treatment-resistant depression.

Development Status and FDA Approval Process for ALKS 5461

DateArticle
Feb  1, 2019Alkermes Receives Complete Response Letter From U.S. Food and Drug Administration for ALKS 5461 New Drug Application
Nov  1, 2018Alkermes Reports on Outcome of FDA Advisory Committee Meeting on ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder
Apr 16, 2018Alkermes Announces FDA Acceptance for Review of New Drug Application for ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder
Apr  2, 2018Alkermes Receives Refusal to File Letter From FDA for ALKS 5461
Jan 31, 2018Alkermes Submits New Drug Application To U.S. FDA For ALKS 5461 For The Adjunctive Treatment Of Major Depressive Disorder
Aug 21, 2017Alkermes Initiates Rolling Submission of ALKS 5461 New Drug Application for Major Depressive Disorder
Oct 20, 2016Alkermes Announces Positive Topline Results From FORWARD-5 Pivotal Phase 3 Study of ALKS 5461 for Major Depressive Disorder
Apr 17, 2013Alkermes Announces Positive Results from Phase 2 Clinical Study of ALKS 5461 for Major Depressive Disorder
May 30, 2012Alkermes Presents Positive Clinical Data of ALKS 5461 at 52nd Annual New Clinical Drug Evaluation Unit Meeting
Jun 15, 2011Alkermes Initiates Clinical Study of ALKS 5461 for Treatment-Resistant Depression

Further information

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