A phase 3 trial of ABP-450 (prabotulinumtoxinA) Injection for the Treatment of Cervical Dystonia

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 16 Aug 2024

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At a glance

12 Aug 2024 According to an AEON Biopharma media release, company has Submitted a briefing package to the FDA that provided extensive data from analytical, pharmacological, and animal studies that could contribute to a Biologics License Application (BLA) filing.
09 Jul 2024 According to an AEON Biopharma media release, the company plan to move ahead with a head-to-head comparison to BOTOX in a cervical dystonia Phase 3 study via the 351(k) pathway following an in-person FDA meeting scheduled for Q3 2024
24 Jul 2023 According to an AEON Biopharma media release, the company plans to initiate this study in 2024.

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