Acadia Pharmaceuticals announced that DAYBUE STIX (trofinetide) for oral solution, a dye- and preservative-free powder formulation of trofinetide, is now broadly available in the United States for treating 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 in December 2025, is bioequivalent to the original DAYBUE oral solution, delivering the same efficacy and safety profile while offering new flexibility regarding dose volume and taste.
Initial feedback from a small group of caregivers following limited launch revealed that more than 80% of early users reported satisfaction with DAYBUE STIX, highlighting the added flexibility and portability. The formulation allows more customized care in real-world settings. DAYBUE STIX is a powder that caregivers can mix with water-based liquids such as juice, tea, lemonade, limeade, or liquid hydration, allowing customization to individual taste preferences. The product comes in individual packets that are easily portable.
Clinical Consensus and Safety Profile
A recent publication of expert recommendations for real-world use of trofinetide in Rett syndrome reinforced the importance of flexible, patient-centered approaches. A steering group of experts from International Rett Syndrome Foundation-designated centers of excellence reached consensus recognizing trofinetide oral solution as part of standard care for individuals with Rett syndrome. The efficacy and safety of DAYBUE STIX is based on pivotal Phase 3 LAVENDER study results with DAYBUE oral solution. Common adverse reactions reported in the 12-week study included diarrhea (82% vs 20% placebo), vomiting (29% vs 12%), fever (9% vs 4%), seizure (9% vs 6%), and anxiety (8% vs 1%). In the 12-week study, 85% of patients treated with DAYBUE experienced diarrhea, with 49% having persistent or recurrent diarrhea despite interventions.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.biospace.com/press-releases/acadia-pharmaceuticals-announces-daybue-stix-trofinetide-is-now-broadly-available-in-the-united-states-for-the-treatment-of-rett-syndrome