Sufentanil sublingual - AcelRx

Drug Profile

Sufentanil sublingual - AcelRx

Alternative Names: ARX-01; ARX-02; ARX-04; ARX-F01; ARX-F02; DSUVIA; DZUVEO; Sublingual sufentanil; Sufentanil sublingual; Sufentanil sublingual microtablet; Sufentanil sublingual tablet system; Zalviso

Latest Information Update: 26 Oct 2017

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At a glance

  • Originator AcelRx Pharmaceuticals
  • Developer AcelRx Pharmaceuticals; Grunenthal
  • Class Amides; General anaesthetics; Opioid analgesics; Piperidines; Small molecules; Thiophenes
  • 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 - Acute pain; Postoperative pain

Highest Development Phases

  • Marketed Postoperative pain
  • Preregistration Acute pain
  • Suspended Cancer pain

Most Recent Events

  • 20 Oct 2017 AcelRx Pharmaceuticals announces intention to resubmit NDA to US FDA for Acute pain by end of 2017
  • 20 Oct 2017 AcelRx completes the phase III IAP312 trial in Postoperative pain in USA before October 2017 (NCT02662764)
  • 12 Oct 2017 US FDA issues a complete response letter for the NDA for sufentanil sublingual in Acute pain
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