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A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy, Safety and Tolerability of ABBV-951 to Oral Carbidopa/Levodopa in Advanced Parkinson's Disease Patients

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Trial Profile

A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy, Safety and Tolerability of ABBV-951 to Oral Carbidopa/Levodopa in Advanced Parkinson's Disease Patients

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Oct 2024

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At a glance

  • Drugs Foscarbidopa/Foslevodopa (Primary) ; Levodopa/carbidopa
  • Indications Parkinson's disease
  • Focus Registrational; Therapeutic Use
  • 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.
  • 18 Apr 2024 Results of subgroup analysis (n=139) assessing efficacy of subcutaneous foslevodopa/foscarbidopa (LDP/CDP) with oral levodopa/carbidopa (LD/CD) across prespecified subgroups of patients with advanced Parkinsons disease presented at the 76th Annual Meeting of the American Academy of Neurology 2024

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