AZSTARYS® is available nationwide
AZSTARYS is Schedule II
The Ligand Activated Therapy, or LAT, platform, is a registered trademark of KemPharm.
SDX is a complex of d-MPH and a serine amino acid ligand. In the lower GI tract, the serine ligand is cleaved off, uniformly producing active d-MPH. The serine moiety is inert and has no biologic activity.2,4-6
Unlike the dual peaks and troughs associated with d-MPH HCI ER,
AZSTARYS features a rapid rise followed by
a smooth and gradual decline
in d-MPH1
Mean plasma concentrations of
d-MPH measured throughout
the day1,a
Results are from a pharmacokinetics study of AZSTARYS in healthy adults under
fasted conditions.1,a The clinical relevance of these data has not been established.
aPlasma concentrations were measured following a single dose of AZSTARYS or d-MPH HCl ER capsule. Mean plasma concentrations continued to gradually decline through 72 hours post dose.1
d-MPH, dexmethylphenidate; ER, extended-release; GI, gastrointestinal; HCl, hydrochloride; 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. Kollins SH, Braeckman R, Guenther S, et al. A randomized, controlled laboratory classroom study of serdexmethylphenidate and d-methylphenidate capsules in children with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2021;31(9):597-609. doi:10.1089/cap.2021.0077
4. 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
5. 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
6. 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
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