Buprenorphine/samidorphan - Alkermes

Drug Profile

Buprenorphine/samidorphan - Alkermes

Alternative Names: ALKS 33-BUP; ALKS 33/buprenorphine; ALKS-5461; BUP-ALKS 33; Buprenorphine/ALKS-33; Buprenorphine/RDC 0313; RDC 0313/buprenorphine; Samidorphan/buprenorphine

Latest Information Update: 09 Nov 2018

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At a glance

  • Originator Alkermes
  • Developer Alkermes plc
  • Class Amides; Antidepressants; Cyclopropanes; Morphinans; Opioid analgesics; Small molecules
  • Mechanism of Action Nociceptin receptor agonists; Opioid delta receptor antagonists; Opioid kappa receptor antagonists; Opioid mu receptor agonists; Opioid mu receptor antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Major depressive disorder
  • No development reported Cocaine abuse

Most Recent Events

  • 01 Nov 2018 Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee reviews NDA and communicates that the benefit-risk profile of buprenorphine/samidorphan is not adequate to support approval in Major depressive disorder
  • 30 Oct 2018 The New Drug Application review for the adjunctive treatment of Major depressive disorder by Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee is planned in November 2018
  • 30 Oct 2018 Pooled safety data for FORWARD-4 and FORWARD-5 trials in Major depressive disorder released by Alkermes
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