Oxymorphone - Endo/Penwest

Drug Profile

Oxymorphone - Endo/Penwest

Alternative Names: EN 3202; EN 3203; Opana; Opana ER

Latest Information Update: 19 Aug 2016

Price : $50

At a glance

  • Originator Endo Pharmaceuticals
  • Class Morphine derivatives; Opioid analgesics; 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.

    No
  • 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.

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Cancer pain; Musculoskeletal pain
  • Phase III Postoperative pain

Most Recent Events

  • 12 Aug 2016 Endo International withdraws sNDA application submited to the US FDA
  • 15 Jun 2016 PDUFA action date extended by US FDA for sNDA for Postoperative pain
  • 24 Feb 2016 Endo Pharmaceuticals plans a phase III trial for Postoperative pain (In neonates, In infants ) in USA (PO, Immediate release and IV) (NCT02687451)
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