Sufentanil sublingual - AcelRx

Drug Profile

Sufentanil sublingual - AcelRx

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

Latest Information Update: 01 Mar 2017

Price : $50

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.

  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

  • 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

  • 27 Feb 2017 FDA assigns PDUFA action date of 12-10-2017 for sufentanil sublingual tablet 30µg (DSUVIA™) for moderate-to-severe Acute pain
  • 27 Feb 2017 The US FDA accepts NDA for sufentanil sublingual tablet 30µg for review
  • 27 Feb 2017 The US FDA intends to hold an Advisory Committee meeting to review sufentanil sublingual tablet application
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