Drug Profile


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: 25 Mar 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.

  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    Major depressive disorder
  • New Molecular Entity No

Highest Development Phases

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

Most Recent Events

  • 15 Feb 2017 Alkermes announces intention to submit NDA to US FDA in second half of 2017 (Alkermes plc 10-K, February 2017)
  • 20 Oct 2016 Adverse events and efficacy data from the phase III FORWARD-5 trial in Major depressive disorder (adjunctive therapy) released by Alkermes
  • 01 Oct 2016 Alkermes completes the phase-III FORWARD-5 clinical trial in Major depressive disorder (Adjunctive treatment) in USA, Canada, Germany and Puerto Rico (Sublingual) (NCT02218008)
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