Nalbuphine extended release

Drug Profile

Nalbuphine extended release

Alternative Names: Nalbuphine ER; Nalbuphine extended-release; PW-4142; T 111

Latest Information Update: 17 Oct 2016

Price : $50

At a glance

  • Originator Penwest Pharmaceuticals
  • Developer Endo Pharmaceuticals; Trevi Therapeutics
  • Class Morphinans; Opioid analgesics; Small molecules
  • Mechanism of Action Opioid kappa receptor agonists; Opioid mu receptor antagonists; Opioid 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

  • Phase II/III Prurigo nodularis; Pruritus
  • Discontinued Pain

Most Recent Events

  • 13 Oct 2016 Efficacy data and adverse event data from a phase II trial in Prurigo Nodularis were released by Trevi Therapeutics
  • 02 Jun 2016 Trevi Therapeutics completes enrolment in its phase II/III trial for Prurigo nodularis in USA, Austria, Germany and Poland
  • 01 Jan 2016 Trevi Therapeutics completes a phase II/III long-term extension trial in Pruritis (uraemic) in USA, Poland and Romania (PO) (NCT02143973)
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