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Sodium oxybate - Avadel Pharmaceuticals

Drug Profile

Sodium oxybate - Avadel Pharmaceuticals

Alternative Names: FT-218; Micropump® sodium oxybate

Latest Information Update: 20 Apr 2021

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At a glance

  • Originator Flamel Technologies
  • Developer Avadel Pharmaceuticals
  • Class Butyric acids; Hydroxybutyrates; Sleep disorder therapies; Small molecules
  • Mechanism of Action GABA B receptor agonists
  • 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 No

Highest Development Phases

  • Preregistration Narcolepsy

Most Recent Events

  • 17 Apr 2021 Updated efficacy data from a phase III REST-ON trial in Narcolepsy released by Avadel Pharmaceuticals
  • 31 Mar 2021 Chemical structure information added
  • 26 Mar 2021 3552216: NDA approval month corrected to Feb 2021 in KDM and Reg HE corrected to 26 Feb 2021. Chem structure addition request already sent
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