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Fentanyl sublingual - BTcP Pharma/Pharmbio Korea

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Drug Profile

Fentanyl sublingual - BTcP Pharma/Pharmbio Korea

Alternative Names: Fentanyl SL spray - INSYS Therapeutics; Fentanyl sublingual spray - INSYS Therapeutics; FSS; Subsys

Latest Information Update: 31 Dec 2021

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At a glance

  • Originator INSYS Therapeutics, Inc
  • Developer INSYS Therapeutics, Inc; M. D. Anderson Cancer Center
  • Class Amides; Benzene derivatives; 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.

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Cancer pain
  • Discontinued Dyspnoea; Postoperative pain

Most Recent Events

  • 27 Jan 2021 M.D. Anderson Cancer Center and INSYS Therapeutics completes a phase II/III trial in Dyspnoea in USA (Sublingual) (NCT02597478)
  • 07 Aug 2020 M.D. Anderson Cancer Center and INSYS Therapeutics terminates phase II trial in Cancer pain in USA (Sublingual) (NCT02514252)
  • 08 May 2018 Lunatus acquires licence for Fentanyl sublingual formulation from INSYS Therapeutics in Bahrain, Jordan, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia and the United Arab Emirates

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