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 Jan 2018

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At a glance

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

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

  • New Molecular Entity No

Highest Development Phases

  • Preregistration Major depressive disorder
  • No development reported Cocaine abuse

Most Recent Events

  • 20 Nov 2017 Alkermes completes the phase III FORWARD-2 trial for Major depressive disorder (Adjunctive therapy) in USA, Australia, Bulgaria, Canada, Germany, Hungary, Slovakia, Poland and Puerto Rico (Sublingual) (NCT02141399) (EudraCT2014-000380-41)
  • 21 Aug 2017 Preregistration for Major depressive disorder (Adjunctive treatment, In the elderly, Treatment-experienced, In adults) in USA (Sublingual)
  • 12 Jun 2017 Alkermes announces intention to submit NDA to US FDA for Major depressive disorder by the end of 2017
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