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Acadia Pharmaceuticals Announces FDA Approval of DAYBUE® STIX (trofinetide) for Oral Solution, a New Powder Formulation of Trofinetide for the Treatment of Rett Syndrome
-- DAYBUE STIX provides Rett syndrome patients and caregivers with new flexibility and choice in their treatment with DAYBUE -- DAYBUE and DAYBUE STIX are
About this update from Acadia Pharmaceuticals Inc.
[{"type":"text","content":"\n-- DAYBUE STIX provides Rett syndrome patients and caregivers with new flexibility and choice in their treatment with DAYBUE\n\n-- DAYBUE and DAYBUE STIX are the only FDA-approved treatments for Rett syndrome, a rare neurodevelopmental disorder\n\n SAN DIEGO--(BUSINESS WIRE)--\nAcadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the U.S. Food and Drug Administration (FDA) has approved DAYBUE® STIX (trofinetide) for oral solution, a dye- and preservative-free powder formulation of trofinetide for the treatment of Rett syndrome in adult and pediatric patients two years of age and older. The new formulation is expected to deliver the same efficacy and safety profile of DAYBUE oral solution, while offering children and adults living with Rett syndrome new flexibility and choice regarding the dose volume and taste of their DAYBUE treatment.\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251211720018/en/\n“DAYBUE, the first and only approved treatment for Rett syndrome, has provided thousands of patients an important therapeutic option,” said Catherine Owen Adams, Acadia’s Chief Executive Officer. “With the approval of DAYBUE STIX, we are building on our commitment to turn scientific promise into meaningful innovation by introducing a new formulation informed by invaluable feedback from patients, caregivers and healthcare providers.”\n\n“The new formulation gives us an additional option for treatment with DAYBUE, allowing us to better customize care for our patients,” said Jennifer Martelle Tu, M.D., Ph.D., Director of Katie's Clinic for Rett Syndrome and Associate Professor of Neurology, UCSF Benioff Children's Hospitals, Oakland. “DAYBUE STIX is a powder for oral solution that caregivers can mix with a variety of water-based liquids providing flexibility to modify the taste and volume of their loved-one's dose. We know that this kind of adaptability is something many Rett families have been seeking.”\n\nThe efficacy and safety of DAYBUE STIX is based on the results of the LAVENDER™ study with DAYBUE oral solution in patients with Rett syndrome. The approval of this new formulation was informed by the results of a bioequivalence study, which demonstrated that both original DAYBUE oral solution and the new DAYBUE STIX for oral solution powder formulation prov...