Drug Approval
Neuren partner Acadia bags FDA go-ahead for new DAYBUE STIX powder for Rett Syndrome
The new powder formulation gives children and adults living with Rett syndrome greater flexibility and choice in dose volume and taste
- By IPP Bureau
| December 16, 2025
Aussie-listed Neuren Pharmaceuticals has announced that its US partner, Acadia Pharmaceuticals, has won FDA approval for DAYBUE STIX (trofinetide) oral solution powder, a dye- and preservative-free formulation for treating Rett syndrome in patients aged two years and older.
The new powder formulation gives children and adults living with Rett syndrome greater flexibility and choice in dose volume and taste. Together with the original DAYBUE, DAYBUE STIX marks the only FDA-approved treatments available for the rare neurological disorder.
Neuren CEO Jon Pilcher said: “The Neuren team is excited about the approval of this new treatment option for Rett syndrome families and the continued investment and innovation for trofinetide by our global partner, Acadia.
"Caregivers can mix DAYBUE STIX with a variety of water-based liquids providing flexibility to modify the taste and volume of their loved-one's dose. We look forward to seeing the impact as DAYBUE STIX becomes more broadly available during 2026.”
The FDA approval follows a bioequivalence study showing that DAYBUE STIX delivers the same exposure, efficacy, and safety as the original oral solution formulation.
Acadia plans to launch DAYBUE STIX on a limited basis in Q1 2026, with broader availability in early Q2 2026. The original oral solution will continue to be offered.
