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Sodium oxybate - Avadel Pharmaceuticals

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Drug Profile

Sodium oxybate - Avadel Pharmaceuticals

Alternative Names: FT-218; LUMRYZ; Micropump® sodium oxybate; ON-SXB

Latest Information Update: 14 Jun 2025

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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; Idiopathic hypersomnia
  • New Molecular Entity No

Highest Development Phases

  • Marketed Narcolepsy
  • Phase III Idiopathic hypersomnia

Most Recent Events

  • 05 Jun 2025 Sodium oxybate - Avadel Pharmaceuticals receives Orphan Drug status for Idiopathic hypersomnia in USA
  • 15 May 2025 Planned Prescription Drug User Fee Act (PDUFA) date for Narcolepsy (In children) in USA (PO) is 2024-09-07
  • 06 May 2025 Federal Circuit decision allows Avadel to seek and be granted uS FDA approval for LUMRYZ in Idiopathic hypersomnia

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