DAYBUE STIX Receives FDA Green Light: Acadia Launches Powder Option for Rett Syndrome Treatment

Acadia Pharmaceuticals Inc. (ACAD) has successfully obtained FDA clearance for DAYBUE STIX, introducing a powder-based variant of its DAYBUE oral solution designed for Rett syndrome patients aged two and above. This milestone marks an expansion in treatment options for a condition that impacts approximately 1 in 10,000 to 15,000 female births globally.

What is Rett Syndrome and Why This Matters

Rett syndrome adalah a rare neurodevelopmental disorder that presents significant clinical challenges. The condition primarily affects females in their early development, leading to progressive neurological deterioration. The approval of DAYBUE STIX addresses a critical need in this patient population by offering an alternative administration method while maintaining the therapeutic efficacy and safety characteristics demonstrated by the original oral solution that received FDA approval in 2023.

Product Specifications and Clinical Profile

The newly approved powder formulation is engineered to deliver identical efficacy and safety outcomes compared to the existing liquid oral solution. This formulation flexibility allows healthcare providers and caregivers greater adaptability in treatment administration, particularly beneficial for pediatric populations where dosing precision and ease of use are paramount considerations.

Market Availability Timeline

DAYBUE STIX will roll out through a phased availability approach beginning in the first quarter of 2026, with full market access anticipated by early second quarter. The original oral solution formulation will continue to remain accessible alongside the new powder option, ensuring uninterrupted supply chains and patient choice in treatment modality.