Mean change in z-scores from baseline to Month 12 for both weight and height indicated
a lower-than-expected increase compared with children of the same age and sex, on
average. A z-score change of <0.5 SD is considered not clinically significant.1
aA long-term, open-label safety study was conducted in pediatric patients aged 6 to 12 years with ADHD. This study was comprised of a 3-week dose-optimization phase
for patients not recently treated with AZSTARYS (from the primary short-term study), followed by a 12-month treatment phase for all patients during which 238 received
open-label AZSTARYS and had evaluable safety data. A total of 154 patients were treated for 12 months. Because of the open-label, uncontrolled design of this study, the
reported adverse reaction rates cannot be assessed in terms of a causal relationship to AZSTARYS treatment.1
bZ-scores show the SD above or below the mean weight or height normalized for the natural growth of children and adolescents by comparison to age- and sex-matched
population standards.1
Because of the study design, the
reported adverse reaction rates cannot
be used to
predict the rates that may
be expected in clinical practice.
cA short-term, randomized, double-blind, placebo-controlled, parallel-group study conducted from December 2017 to May 2018 in pediatric patients aged 6 to 12 years
with ADHD. The study included a 3-week, open-label, dose-optimization phase in which all patients received AZSTARYS (N=155). Five patients discontinued
treatment during this phase. This was followed by a 1-week, double-blind, controlled phase in which patients were randomized to continue AZSTARYS (n=74) or switch to
placebo (n=76).1,2
d-MPH, dexmethylphenidate; MPH, methylphenidate; SDX, serdexmethylphenidate; TEAE, treatment-emergent adverse event.
References: 1. AZSTARYS. Prescribing information.
Corium Inc; 2021. 2. Data on file; Corium Inc.
AZSTARYS is a central nervous system
(CNS) stimulant indicated for the
treatment of Attention Deficit
Hyperactivity Disorder
(ADHD) in
patients 6 years and older.
WARNING: ABUSE AND DEPENDENCE
Please click here for Full
Prescribing Information,
including Boxed WARNING.
AZSTARYS is a central nervous system
(CNS) stimulant indicated for the
treatment of Attention Deficit
Hyperactivity Disorder (ADHD) in
patients 6 years and older.
WARNING: ABUSE AND DEPENDENCE