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