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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: 26 May 2020

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At a glance

  • Originator Alkermes
  • Developer Alkermes plc
  • Class Amides; Antidepressants; Cyclopropanes; Drug withdrawal therapies; 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.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Major depressive disorder
  • No development reported Cocaine-related disorders

Most Recent Events

  • 19 May 2020 Alkermes terminates a phase III trial in Major depressive disorder in USA, Australia and Puerto Rico (sublingual) due to sponsor's decision (NCT03610048)
  • 05 Mar 2020 Alkermes completes a phase III trial for Major depressive disorder (Adjunctive treatment) in Australia, Puerto Rico and USA (Sublingual) (NCT03188185)
  • 20 May 2019 Final adverse events and efficacy data from phase III FORWARD-2 trial in Major depressive disorder presented at the 172nd Annual Meeting of the American Psychiatric Association (APA-2019)
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