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Tapentadol immediate-release - Grunenthal

Drug Profile

Tapentadol immediate-release - Grunenthal

Alternative Names: BN-200; CG-5503; Nucynta; Palexia; R-331333; Tapentadol HCl immediate release; Tapentadol hydrochloride; Tapentadol IR; Tapentadol OS

Latest Information Update: 04 Jul 2019

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At a glance

  • Originator Grunenthal
  • Developer Grunenthal; Janssen Research & Development; Ortho-McNeil
  • Class Opioid analgesics; Phenols; Small molecules
  • Mechanism of Action Alpha 2 adrenergic receptor antagonists; 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
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Pain
  • Phase III Postoperative pain

Most Recent Events

  • 30 Jun 2019 Grunenthal plans a phase-II trial for Pain in Poland (EudraCT2019-000205-77)
  • 28 Mar 2019 The United States Court of Appeals for the Federal Circuit rules in favour of Assetio Therapeutics against ANDAs for the NUCYNTA® franchise
  • 14 Mar 2019 Grünenthal completes a phase III trial in Postoperative pain (In adolescents, In children, In infants, In neonates) in United Kingdom, Austria, Germany, USA, Bulgaria, Croatia, Czech Republic, France, Hungary, Poland, Puerto Rico and Spain (PO) (NCT02081391) (EudraCT2012-004359-35)
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