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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 LLC; 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, MISUSE, AND ADDICTION
AZSTARYS has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including AZSTARYS, can result in overdose and death and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.
Before prescribing AZSTARYS, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.
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, MISUSE, AND ADDICTION
AZSTARYS has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including AZSTARYS, can result in overdose and death and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.
Before prescribing AZSTARYS, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.
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