Drug Profile


Alternative Names: E-58425; MR308; Tramadol Celecoxib

Latest Information Update: 11 Jan 2017

Price : $50

At a glance

  • Originator ESTEVE
  • Developer ESTEVE; Mundipharma GmbH
  • Class Analgesics; Anti-inflammatories; Cyclohexanols; Dimethylamines; Non-opioid analgesics; Nonsteroidal anti-inflammatories; Opioid analgesics; Phenyl ethers; Pyrazoles; Small molecules; Sulfonamides
  • Mechanism of Action Adrenergic uptake inhibitors; Cyclo-oxygenase 2 inhibitors; Opioid mu receptor agonists; Serotonin uptake inhibitors
  • 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 Yes

Highest Development Phases

  • Phase III Acute pain
  • Phase II Dental pain; Pain

Most Recent Events

  • 05 Dec 2016 Phase-III clinical trials in Acute pain in Spain (PO) (EudraCT2016-000593-38)
  • 01 Dec 2016 Phase-III clinical trials in Acute pain in Hungary (PO) (NCT02982161)
  • 30 Nov 2016 Mundipharma Research plans the phase III STARDOM1 trial for Acute pain (following dental procedure) in Canada, France, Germany, Hungary, Italy, Japan, Poland and Spain (PO, Tablet) (NCT02982161)
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