FDA Approves Acadia's Powder Formulation Of DAYBUE For Rett Syndrome

(RTTNews) - Acadia Pharmaceuticals Inc. (ACAD) on Friday announced that the U.S. Food and Drug Administration (FDA) has approved DAYBUE STIX, a powder formulation of DAYBUE oral solution, for the treatment of Rett syndrome in patients aged two years and older.

Rett syndrome is a rare neurodevelopmental disorder affecting approximately one in every 10,000 to 15,000 female births worldwide.

The powder formulation is expected to provide the same efficacy and safety profile as the DAYBUE oral solution approved in 2023.

The company said DAYBUE STIX will be available on a limited basis starting in the first quarter of 2026, with broader availability expected early in the second quarter, while the current oral solution formulation will remain available.