Acadia gets DAYBUE STIX label approval; updates carbetocin Phase 3 results for PWS hyperphagia

Acadia Pharmaceuticals had two registry updates of note during the week, including a new drug approval and a correction to posted trial results.

• DAYBUE STIX, an oral trofinetide product from Acadia Pharms Inc in multiple packet strengths (5000MG, 6000MG, and 8000MG per packet, plus 10,000MG and 12,000MG solution strengths), had a labeling supplement (SUPPL 1) approved under NDA219884, with a submission status date of October 16, 2026.
• The completed Phase 3 trial "A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome" (NCT06173531), sponsored by ACADIA Pharmaceuticals Inc., posted updated results. <cite index="2-12">Posted results showed a change from baseline at week 12 of -4.8 (spread 0.78) in the Hyperphagia Questionnaire for Clinical Trials score for carbetocin.¹ The trial enrolled 175 participants.²