Daybue Stix

Treats Rett syndrome. NDA 219884, held by Acadia Pharms Inc. Trofinetide.

As of Nov 14, 2026, NDA 219884 (Daybue Stix), held by Acadia Pharms Inc, was first approved by FDA on Dec 11, 2025, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 11, 2025
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

DAYBUE and DAYBUE STIX are indicated for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older. DAYBUE and

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Dec 11, 2025	Original applicationNew dosage form · Standard review	Approved	Letter

Products

5 strengths and forms


Daybue Stix5000MG/PACKET · for solution;oral	Trofinetide	RxReference drug
Daybue Stix6000MG/PACKET · for solution;oral	Trofinetide	RxReference drug
Daybue Stix8000MG/PACKET · for solution;oral	Trofinetide	RxReference drug
Daybue Stix10,000MG · solution; oral	Trofinetide	Rx
Daybue Stix12,000MG · solution; oral	Trofinetide	Rx

All 2 submissions, including labeling and manufacturing supplements


Oct 16, 2026	Supplement 1Labeling · Standard review	Approved	Letter Label
Dec 11, 2025	Original applicationNew dosage form · Standard review	Approved	Letter

Identifiers

Application: NDA 219884
Drugs@FDA: Overview at FDA
Company: ACADIA Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters