A day with
Consider a treatment that lasts
up to 16 hours post dose
measured from 2 or 4 hours.1
MYDAYIS® is the first and only mixed amphetamine salts (MAS) formulation that may help with improved attention up to 16 hours post-dose (measured from 2 or 4 hours) with once-daily dosing.1
Primary Endpoint1: Significant improvements in attention based on LS mean PERMP total scores up to 16 h post-dose. In Study 2, patients treated with Mydayis 50 mg had higher scores at 2 h and up to 16 h post-dose. In Study 3, patients on Mydayis 25 mg had higher scores at 4 h and up to 16 h post-dose.Why Mydayis
for prolonged release
For over 20 years, Shire has been committed to ADHD research to help meet the needs of patients. Mydayis is the first ADHD treatment to use triple-bead delivery for extended release of MAS medication through the morning, afternoon, and evening.1
Immediate release in the stomach
Release at pH 5.5
Release at pH 7.0
Beads shown are not actual size or color.
Three types of beads in a single capsule release at different pH levels for prolonged amphetamine delivery.1See how it works
Up to 16 hours
post-dose (measured from 2 or 4 hours)
vs placebo based on PERMP
IMPORTANT SAFETY INFORMATION (continued)
- Known hypersensitivity to amphetamines or other ingredients of Mydayis. Angioedema and anaphylactic reactions have been reported with other amphetamines.
- Use with monoamine oxidase inhibitors (MAOIs) or within 14 days of last MAOI dose, due to increased risk of hypertensive crisis.
In a prespecified supplementary analysis in Study 2, patients receiving Mydayis 50 mg demonstrated significant improvement in attention vs placebo on PERMP total score measured from 2 to 16 hours post-dose. The post-dose average score over all testing sessions was 285 for Mydayis and 262 for placebo (P <0.0001).1,2
Efficacy with Mydayis was the primary endpoint in 2 phase II randomized, double-blind, placebo-controlled studies. Attention in ADHD was measured by the PERMP administered before dosing and at intervals up to 16 hours after dosing. PERMP is a skill-adjusted math test that is scored as the sum of math problems attempted and problems answered correctly.1-3
Another Duration of Effect Study
In the separate Study 3, adult patients who took Mydayis 25 mg experienced significantly greater improvement in attention from hours 4-16 post-dose compared with placebo on PERMP total score. The post-dose average score over all testing sessions was 268 for Mydayis and 249 for placebo (P <0.0001).1,3
*Until the offer expires. Eligibility and restrictions apply.
- Mydayis [package insert]. Lexington, MA; Shire US Inc.
- Data on file; SPD465-201; Shire US Inc.
- Data on file; SPD465-203; Shire US Inc.