Buprenorphine/samidorphan

Drug Profile

Buprenorphine/samidorphan

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: 19 Jun 2017

Price : $50

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.

    No
  • New Molecular Entity No

Highest Development Phases

  • Phase III Major depressive disorder
  • No development reported Cocaine abuse

Most Recent Events

  • 12 Jun 2017 Alkermes announces intention to submit NDA to US FDA for Major depressive disorder by the end of 2017
  • 12 Jun 2017 Alkermes initiates enrolment in a phase IIIb (study 217) trial for Major depressive disorder (Adjunctive treatment, Treatment-experienced, In adults, In the elderly) in USA (Sublingual) (NCT03188185)
  • 20 Oct 2016 Adverse events and efficacy data from the phase III FORWARD-5 trial in Major depressive disorder (adjunctive therapy) released by Alkermes
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