Solriamfetol - Jazz Pharmaceuticals/SK Biopharmaceuticals

Drug Profile

Solriamfetol - Jazz Pharmaceuticals/SK Biopharmaceuticals

Alternative Names: ADX-N05; ARL-N05; JZP-110; SKL-N05

Latest Information Update: 06 Mar 2018

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At a glance

  • Originator SK Holdings
  • Developer Jazz Pharmaceuticals plc; SK biopharmaceuticals
  • Class Carbamates; Sleep disorder therapies
  • Mechanism of Action Adrenergic uptake inhibitors; Dopamine uptake inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Narcolepsy
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Narcolepsy; Sleep apnoea syndrome
  • Phase II Hypersomnia
  • Phase I Renal failure
  • No development reported Depressive disorders

Most Recent Events

  • 15 Mar 2018 Jazz Pharmaceuticals announces intention to submit regulatory application in the European Union for Narcolepsy and Sleep apnoea syndrome by late 2018 (Jazz Pharmaceuticals pipeline, March 2018)
  • 02 Mar 2018 FDA assigns PDUFA action date of 20/12/2018 for solriamfetol for Narcolepsy and Sleep apnoea syndrome
  • 02 Mar 2018 The US FDA accepts NDA for Solriamfetol for Narcolepsy and Sleep apnoea syndrome, for review
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