Buprenorphine sublingual spray - INSYS Therapeutics

Drug Profile

Buprenorphine sublingual spray - INSYS Therapeutics

Latest Information Update: 10 Aug 2018

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At a glance

  • Originator INSYS Pharma
  • Developer INSYS Therapeutics, Inc
  • Class Cyclopropanes; Morphinans; Opioid analgesics; Small molecules
  • Mechanism of Action Nociceptin receptor agonists; Opioid delta receptor antagonists; Opioid kappa receptor antagonists; 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

  • Preregistration Postoperative pain

Most Recent Events

  • 27 Jul 2018 INSYS Therapeutics receives a complete response letter from the US FDA for Buprenorphine sublingual spray in post-operative-pain
  • 22 May 2018 The US FDA advisory committee does not recommend the use of buprenorphine sublingual spray for Post-operative pain
  • 08 Dec 2017 Planned Prescription Drug User Fee Act (PDUFA) date for Postoperative pain in USA (Sublingual) is 2018-07-28
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