-- DAYBUE STIX is a new powder formulation of trofinetide

-- Recently published expert consensus recognizes trofinetide as part of the standard of care for Rett syndrome and highlights the importance of flexible, patient-centered treatment approaches

Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced DAYBUE® STIX (trofinetide) for oral solution, a dye- and preservative-free powder formulation of trofinetide, is now broadly available in the United States for the treatment of Rett syndrome in adults and pediatric patients two years of age and older. The new formulation, approved by the U.S. Food and Drug Administration (FDA) in December 2025, is bioequivalent to the original DAYBUE® oral solution, delivering the same efficacy and safety profile, while offering children and adults living with Rett syndrome new flexibility and choice regarding the dose volume and taste of their DAYBUE treatment.1

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"Initial feedback from a small group of caregivers following the limited launch revealed that more than 80% of early users reported satisfaction with DAYBUE STIX, highlighting the added flexibility and portability of this new formulation,"2 said Tom Garner, Acadia's Chief Commercial Officer. "We are hearing that the new formulation may allow for more customized care in real-world settings. Ongoing evaluation from patients and caregivers remains a priority; their perspectives are essential as we identify ways to better assist families managing this complex condition."

The importance of flexible, patient-centered approaches was reinforced in a recent publication of expert recommendations for real-world use of trofinetide in Rett syndrome. A steering group comprised of experts based at International Rett Syndrome Foundation (IRSF)-designated centers of excellence (COEs) reached consensus recognizing trofinetide oral solution as part of the standard of care for individuals with Rett syndrome. They also aligned on key real-world considerations such as early initiation and sustained use over time. The recommendations also reflect shared perspectives on the need for individualized decision making in clinical practice to help optimize outcomes for patients, families, and caregivers.3