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: 18 Jun 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 Opioid mu receptor antagonists
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Major depressive disorder
  • No development reported Cocaine abuse

Most Recent Events

  • 01 Aug 2018 Alkermes plans a phase IIIb extension trial for Major depressive disorder (Adjunctive treatment) (Sublingual) , (NCT03610048)
  • 07 May 2018 9239185 - no updates. Minor change in introduction
  • 05 May 2018 Adverse events and efficacy data from phase III FORWARD-2 trial in Major depressive disorder presented at the 171st Annual Meeting of the American Psychiatric Association (APA-2018)
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