Fentanyl buccal - BioDelivery Sciences

Drug Profile

Fentanyl buccal - BioDelivery Sciences

Alternative Names: BEMA-Fentanyl; Breakyl; Fentanyl buccal soluble film; Fentanyl transmucosal - BioDelivery Sciences; Onsolis; Painkyl

Latest Information Update: 21 Dec 2017

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At a glance

  • Originator QLT USA
  • Developer BioDelivery Sciences International; Meda; TTY Biopharm
  • Class General anaesthetics; Opioid analgesics; Piperidines; Small molecules
  • Mechanism of Action Opioid mu receptor agonists
  • Orphan Drug Status

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

  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Marketed Cancer pain

Most Recent Events

  • 14 Dec 2017 BioDelivery Sciences International receives the required 90-day notice from Collegium Pharmaceutical regarding termination of the license and development agreement for fentanyl buccal soluble film
  • 09 Aug 2017 BioDelivery Sciences plans to launch fentanyl buccal in USA in the first half of 2018
  • 15 May 2017 BioDelivery Science International intends to submit a regulatory application with US FDA to qualify new manufacturer Collegium Pharmaceutical in 2018
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