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A 52-Week, Open-label, Single-arm Study to Evaluate the Safety and Tolerability of 24-hour Daily Exposure of Continuous Subcutaneous Infusion of ABBV-951 in Subjects With Parkinson's Disease

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Trial Profile

A 52-Week, Open-label, Single-arm Study to Evaluate the Safety and Tolerability of 24-hour Daily Exposure of Continuous Subcutaneous Infusion of ABBV-951 in Subjects With Parkinson's Disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Oct 2025

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At a glance

  • Drugs Foscarbidopa/Foslevodopa (Primary)
  • Indications Parkinson's disease
  • Focus Adverse reactions; Registrational
  • Acronyms Galliarde
  • Sponsors AbbVie

Most Recent Events

  • 17 Oct 2024 According to an AbbVie media release, the U.S. Food and Drug Administration (FDA) has approved VYALEV™ (foscarbidopa and foslevodopa) as the first and only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of motor fluctuations in adults with advanced Parkinson's disease (PD).
  • 25 Jun 2024 According to an AbbVie media release, the company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) for ABBV-951 (foscarbidopa/foslevodopa) for the treatment of motor fluctuations in adults with advanced Parkinson's disease. The CRL does not request that AbbVie conduct additional efficacy and safety trials related to the drug or device-related testing.
  • 08 Feb 2024 According to an AbbVie media release,Health Canada approval of VYALEV was supported by the pivotal Phase 3 M15-7411 study.

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