Fentanyl sublingual - INSYS Therapeutics

Drug Profile

Fentanyl sublingual - INSYS Therapeutics

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

Latest Information Update: 24 May 2018

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At a glance

  • Originator INSYS Therapeutics, Inc
  • Developer INSYS Therapeutics, Inc; M. D. Anderson Cancer Center
  • 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

Highest Development Phases

  • Marketed Cancer pain
  • Phase II/III Dyspnoea
  • Phase II Postoperative pain

Most Recent Events

  • 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
  • 21 Dec 2017 Insys Therapeutics withdrew a phase III trial as the sponsor elected not to continue with study for Procedural pain in USA (Sublingual) (NCT02138409)
  • 10 Feb 2017 INSYS Therapeutics completes a phase II trial for Post-operative pain in USA (Sublingual) (NCT02915978)
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