Buprenorphine/naloxone transmucosal - BioDelivery Sciences International

Drug Profile

Buprenorphine/naloxone transmucosal - BioDelivery Sciences International

Alternative Names: B-BNX; BEMA® Buprenorphine NX; BEMA® Buprenorphine/Naloxone; BNX; BUNAVAIL; Buprenorphine/naloxone buccal film; Buprenorphine/Naloxone buccal soluble film; Naloxone/buprenorphine - BioDelivery Sciences International; Naloxone/buprenorphine transmucosal - BioDelivery Sciences International

Latest Information Update: 19 Oct 2015

Price : $50

At a glance

  • Originator BioDelivery Sciences International
  • Class Antidotes; 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
  • 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.

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Opioid abuse

Most Recent Events

  • 15 Oct 2015 The US FDA approves sNDA for a manufacturing specification change for buprenorphine/naloxone
  • 07 Aug 2015 BioDelivery Sciences International plans a phase III trial for Opioid abuse in USA (NCT02516436)
  • 03 Nov 2014 Launched for Opioid abuse in USA (Transmucosal) - First global launch
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