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Drug Profile

Tapentadol controlled-release - Grunenthal/Janssen Research & Development/Ortho-McNeil

Alternative Names: BN200 ER; BN200 PR; CG 5503 ER; CG 5503 PR; JNS024ER; Nucynta ER; Palexia Depot; Palexia Retard; Palexia RP; Palexia SR; Palexia XR; R331333 PR; Tapenta;… See more

Latest Information Update: 17 Jun 2024

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At a glance

  • Originator Grunenthal
  • Developer Collegium Pharmaceutical; Grunenthal; Janssen Pharmaceutical KK; Janssen Research & Development
  • Class Amines; Opioid analgesics; Phenols; Small molecules
  • Mechanism of Action Adrenergic uptake inhibitors; 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 No

Highest Development Phases

  • Marketed Cancer pain; Diabetic neuropathies; Pain
  • Discontinued Neuropathic pain

Most Recent Events

  • 31 Dec 2023 Preregistration for Pain (In children) in USA (PO) before December 2023
  • 09 Mar 2022 No development reported - Phase-II/III for Pain (In adolescents, In children) in Chile (PO)
  • 31 Dec 2021 Collegium Pharmaceutical files prior approval supplement for an alternate tapentadol CR manufacturing site

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