FDA-Approved DAYBUE is

NOW AVAILABLE

The first and only approved treatment for Rett syndrome1,2

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Introducing DAYBUE [day-BYOO], a new prescription oral therapy for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older.1

Here's how to say DAYBUE

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Get to know the key clinical data from the pivotal Phase 3 trial for DAYBUE.

Download the Key Data
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Download our frequently asked questions document to share with your Caregivers.

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Download information on the effectiveness and safety of DAYBUE for your Caregivers considering DAYBUE treatment.

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Register Now

Webinars will include presentations from leading experts in Rett syndrome, including:

Headshot for Arthur Beisang

Arthur Beisang, MD

Assistant Professor
University of Minnesota
Minneapolis, MN

Co-Director of the Rett and Rett Related Disorders Clinic
Gillette Children’s Specialty Healthcare
St. Paul, MN

Headshot of Tim Feyma

Timothy Feyma, MD

Adjunct Professor
University of Minnesota
Minneapolis, MN

Associate Medical Director of Neurology
Gillette Children’s Specialty Healthcare
St. Paul, MN

Headshot of Carrie Buchanan

Carrie Buchanan, MD

Developmental-Behavioral Pediatrician
Greenwood Genetic Center
Greenville, SC

Headshot of Alan Percy

Alan Percy, MD

Professor, Division of Pediatric Neurology
The University of Alabama at Birmingham
Birmingham, AL

The Acadia Connect team is here to support you and your patients through the journey ahead

Acadia connect
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The Acadia Connect team is here to support you and your patients through the journey ahead

Acadia Connect is a patient and family support program that connects you, your patients, and their family members with dedicated tools and resources in the treatment journey after patients have been prescribed DAYBUE.

Acadia Connect offers healthcare providers and practices support services in the following areas:

  • Access and coverage support services, including benefits investigations and information to assist with prior authorizations and appeals processes

  • Information on appropriate financial assistance options for eligible patients

  • Coordination of medication delivery to patients through AnovoRx Specialty Pharmacy

  • Support and education throughout the DAYBUE treatment journey

Acadia Connect offers your patients and caregivers support services in the following areas:

  • Help to understand and verify insurance coverage

  • Information on appropriate financial assistance options

  • Support and education throughout the DAYBUE treatment journey

  • Coordination with AnovoRx Specialty Pharmacy for timely delivery of DAYBUE

GET YOUR PATIENTS STARTED IN 3 STEPS:

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Download DAYBUE
Prescription and Enrollment Form

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Fax the completed form to Acadia Connect at 1-888-385-2748

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You will receive a receipt of enrollment and a Nurse Care Coordinator will reach out within 24 hours.

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Call Acadia Connect at 1-844-737-2223, Monday to Friday, 8AM to 8PM ET, or visit acadiaconnect.com to learn more about our personalized support program designed to help meet the needs of your patients taking DAYBUE.

Important Safety Information

  • Warnings and Precautions

    • Diarrhea: In a 12-week study and in long-term studies, 85% of patients treated with DAYBUE experienced diarrhea. In those treated with DAYBUE, 49% either had persistent diarrhea or recurrence after resolution despite dose interruptions, reductions, or concomitant antidiarrheal therapy. Diarrhea severity was of mild or moderate severity in 96% of cases. In the 12-week study, antidiarrheal medication was used in 51% of patients treated with DAYBUE.
      Patients should stop taking laxatives before starting DAYBUE. If diarrhea occurs, patients should notify their healthcare provider, consider starting antidiarrheal treatment, and monitor hydration status and increase oral fluids, if needed. Interrupt, reduce dose, or discontinue DAYBUE if severe diarrhea occurs or if dehydration is suspected.

    • Weight Loss: In the 12-week study, 12% of patients treated with DAYBUE experienced weight loss of greater than 7% from baseline, compared to 4% of patients who received placebo. In long-term studies, 2.2% of patients discontinued treatment with DAYBUE due to weight loss. Monitor weight and interrupt, reduce dose, or discontinue DAYBUE if significant weight loss occurs.

  • Adverse Reactions: The common adverse reactions (≥5% for DAYBUE-treated patients and at least 2% greater than in placebo) reported in the 12-week study were diarrhea (82% vs 20%), vomiting (29% vs 12%), fever (9% vs 4%), seizure (9% vs 6%), anxiety (8% vs 1%), decreased appetite (8% vs 2%), fatigue (8% vs 2%), and nasopharyngitis (5% vs 1%).

  • Drug Interactions: Effect of DAYBUE on other Drugs

    • DAYBUE is a weak CYP3A4 inhibitor; therefore, plasma concentrations of CYP3A4 substrates may be increased if given concomitantly with DAYBUE. Closely monitor when DAYBUE is used in combination with orally administered CYP3A4 sensitive substrates for which a small change in substrate plasma concentration may lead to serious toxicities.

    • Plasma concentrations of OATP1B1 and OATP1B3 substrates may be increased if given concomitantly with DAYBUE. Avoid the concomitant use of DAYBUE with OATP1B1 and OATP1B3 substrates for which a small change in substrate plasma concentration may lead to serious toxicities.

  • Use in Specific Population: Renal Impairment

    • DAYBUE is not recommended for patients with moderate or severe renal impairment.

DAYBUE is available as an oral solution (200mg/mL).

Indication

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

Please read the full Prescribing Information.

Important Safety Information

  • Warnings and Precautions

    • Diarrhea: In a 12-week study and in long-term studies, 85% of patients treated with DAYBUE experienced diarrhea. In those treated with DAYBUE, 49% either had persistent diarrhea or recurrence after resolution despite dose interruptions, reductions, or concomitant antidiarrheal therapy. Diarrhea severity was of mild or moderate severity in 96% of cases. In the 12-week study, antidiarrheal medication was used in 51% of patients treated with DAYBUE.
      Patients should stop taking laxatives before starting DAYBUE. If diarrhea occurs, patients should notify their healthcare provider, consider starting antidiarrheal treatment, and monitor hydration status and increase oral fluids, if needed. Interrupt, reduce dose, or discontinue DAYBUE if severe diarrhea occurs or if dehydration is suspected.

    • Weight Loss: In the 12-week study, 12% of patients treated with DAYBUE experienced weight loss of greater than 7% from baseline, compared to 4% of patients who received placebo. In long-term studies, 2.2% of patients discontinued treatment with DAYBUE due to weight loss. Monitor weight and interrupt, reduce dose, or discontinue DAYBUE if significant weight loss occurs.

  • Adverse Reactions: The common adverse reactions (≥5% for DAYBUE-treated patients and at least 2% greater than in placebo) reported in the 12-week study were diarrhea (82% vs 20%), vomiting (29% vs 12%), fever (9% vs 4%), seizure (9% vs 6%), anxiety (8% vs 1%), decreased appetite (8% vs 2%), fatigue (8% vs 2%), and nasopharyngitis (5% vs 1%).

  • Drug Interactions: Effect of DAYBUE on other Drugs

    • DAYBUE is a weak CYP3A4 inhibitor; therefore, plasma concentrations of CYP3A4 substrates may be increased if given concomitantly with DAYBUE. Closely monitor when DAYBUE is used in combination with orally administered CYP3A4 sensitive substrates for which a small change in substrate plasma concentration may lead to serious toxicities.

    • Plasma concentrations of OATP1B1 and OATP1B3 substrates may be increased if given concomitantly with DAYBUE. Avoid the concomitant use of DAYBUE with OATP1B1 and OATP1B3 substrates for which a small change in substrate plasma concentration may lead to serious toxicities.

  • Use in Specific Population: Renal Impairment

    • DAYBUE is not recommended for patients with moderate or severe renal impairment.

DAYBUE is available as an oral solution (200mg/mL).

Indication

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

Please read the full Prescribing Information.

References: 1. Acadia Pharmaceuticals Inc. DAYBUE [Package Insert]. San Diego, CA, 2023. 2. Acadia Pharmaceuticals announces U.S. FDA approval of DAYBUE™ (trofinetide) for the treatment of Rett syndrome in adult and pediatric patients two years of age and older. [press release]. Acadia Pharmaceuticals Inc. March 10, 2023.