Improvement in ADHD symptoms was demonstrated using SKAMP, a 13-item validated
assessment of classroom behaviors in children with ADHD,1 including3,4,a
Primary end point: mean change from baseline of SKAMP-C scores averaged over 13 hours.
Assessments were conducted at baseline and 0.5, 1, 2, 4, 8, 10, 12, and 13 hours post dose.
The LS mean change from baseline was -4.87 with AZSTARYS and 0.54 with placebo.1
aDecrease in SKAMP-C scores indicates symptom improvement.1
bBaseline score was assessed at predose on the practice classroom day/randomization visit after
2 days of active drug washout.1
cDifference (active drug minus placebo) in LS mean change from baseline.1
d-MPH, dexmethylphenidate; GI, gastrointestinal; IR, immediate-release; SDX, serdexmethylphenidate.
References: 1. AZSTARYS. Prescribing information.
Corium Inc; 2021. 2. Mickle T, Guenther S, Chi G,
inventors; KemPharm, Inc, assignee. Methylphenidate-
prodrugs, processes of
making and using the same.
U.S. patent 10,584,113. March 10, 2020. 3. Childress
AC, Komolova M, Sallee FR. An update on the
pharmacokinetic considerations in the treatment of
ADHD with long-acting methylphenidate and
amphetamine formulations. Expert Opin Drug Metab
Toxicol. 2019;15(11):937-974.
doi:10.1080/17425255.2019.1675636 4. Patrick
KS,
Radke JL, Raymond JR, et al. Drug regimen
individualization for attention-deficit/hyperactivity
disorder: guidance for methylphenidate and
dexmethylphenidate formulations.
Pharmacotherapy.
2019;39(6):677-688. doi:10.1002/phar.2190 5. Gudin JA, Nalamachu SR. An overview of prodrug technology and its application for developing abuse-deterrent
opioids. Postgrad Med. 2016;128(1):97-105. doi:10.1080/00325481.2016.1126186
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