Bupivacaine extended release - Pacira Pharmaceuticals

Drug Profile

Bupivacaine extended release - Pacira Pharmaceuticals

Alternative Names: Bupivacaine extended-release - Pacira Pharmaceuticals; Bupivacaine extended-release liposome injection; Bupivacaine liposome extended-release injectable suspension; Bupivacaine liposome injectable suspension; DepoBupivacaine; Exparel; SKY-0402

Latest Information Update: 26 Feb 2018

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At a glance

  • Originator SkyePharma Inc
  • Developer Pacira Pharmaceuticals
  • Class Anilides; Local anaesthetics; Non-opioid analgesics; Pipecolic acids; Small molecules
  • Mechanism of Action Sodium channel antagonists
  • 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

Highest Development Phases

  • Marketed Postoperative pain
  • Preregistration Anaesthesia
  • Phase III Dental pain
  • No development reported Musculoskeletal pain; Pain

Most Recent Events

  • 15 Feb 2018 Anesthetic and Analgesic Drug Products Advisory Committee of the US FDA did not reach a unanimous decision on the efficacy and safety of use of EXPAREL® to produce analgesia
  • 15 Feb 2018 Pacira Pharmaceuticals initiates phase I trials for Post-operative pain (Prevention) in USA (NCT03428984)
  • 08 Nov 2017 FDA assigns PDUFA action date of 06/04/2018 for Bupivacaine extended release - Pacira Pharmaceuticals for Anaesthesia (via Nerve block)
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