AZSTARYS® (serdexmethylphenidate and dexmethylphenidate) 26.1/5.2 mg, 39.2/7.8 mg, 52.3/10.4 mg capsules

AZSTARYS is designed to provide immediate and extended
d-MPH activity with a smooth and gradual offset1,3,4

AZSTARYS is Schedule II

  • Rapid d-MPH is immediately
    released.1,4
  • Bioactivation SDX travels to the lower GI tract,
    where it is bioactivated.1,5,6     Using proprietary Ligand
    Activated Therapy® technology,
    SDX is converted to d-MPH.4,5
  • Continuous The continuous conversion of
    d-MPH provides active drug
    throughout the day with a
    smooth and gradual offset.1,3,4

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

AZSTARYS continuously produces controlled
amounts of d-MPH throughout the day1,2,4,5

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

Girl in a library Girl in a library

Sustained
symptom coverage
throughout the day

Safety studied in
pediatric patients

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

INDICATION

AZSTARYS is a central nervous system
(CNS) stimulant indicated for the
treatment of Attention Deficit
Hyperactivity Disorder
(ADHD) in
patients 6 years and older.

Important Safety
Information

WARNING: ABUSE AND DEPENDENCE

  • CNS stimulants, including
    AZSTARYS, other methylphenidate-
    containing products, and
    amphetamines, have a high
    potential
    for abuse and
    dependence. Assess the risk of
    abuse prior to prescribing, and
    monitor for signs of abuse and
    dependence
    while on therapy

Contraindications

  • Known hypersensitivity to
    serdexmethylphenidate,
    methylphenidate, or other product
    components. Bronchospasm, rash,
    and
    pruritus have occurred with
    AZSTARYS. Hypersensitivity reactions
    such as angioedema and anaphylactic
    reactions have occurred
    with other
    methylphenidate products.
  • Concomitant treatment with a
    monoamine oxidase inhibitor (MAOI)
    or use of an MAOI within the
    preceding 14 days, because of
    the risk
    of hypertensive crisis.

Warnings and Precautions

  • Sudden death has been reported in
    association with CNS stimulant
    treatment at recommended doses in
    pediatric patients with
    structural
    cardiac abnormalities or other
    serious heart problems. In adults,
    sudden death, stroke, and myocardial
    infarction have
    been reported at
    recommended doses. Avoid use in
    patients with known structural
    cardiac abnormalities, cardiomyopathy,
    serious heart arrhythmias, coronary artery disease, or other serious heart problems.
  • CNS stimulants cause an increase in
    blood pressure and heart rate. Monitor
    all patients for hypertension and
    tachycardia.
  • Exacerbation of Pre-existing
    Psychosis    : May exacerbate symptoms
    of behavior disturbance and thought
    disorder in patients with
    a pre-existing
    psychotic disorder. Induction of a
    Manic Episode in Patients with Bipolar
    Disorder    : May induce a mixed/manic
    episode in patients with bipolar
    disorder. Prior to initiating treatment,
    screen for risk factors for developing a
    manic episode (e.g.,
    comorbid or
    history of depressive symptoms, or a
    family history of suicide, bipolar
    disorder, or depression). New
    Psychotic or
    Manic Symptoms    : At
    recommended doses, may cause
    psychotic or manic symptoms (e.g.,
    hallucinations, delusional thinking, or
    mania) in patients without a history of
    psychotic illness or mania. Discontinue
    if symptoms occur.
  • Cases of painful and prolonged penile
    erections and priapism have been
    reported with methylphenidate
    products. Immediate
    medical
    attention should be sought if signs or
    symptoms of prolonged penile
    erections or priapism are observed.
  • CNS stimulants, including AZSTARYS,
    are associated with peripheral
    vasculopathy, including Raynaud’s
    phenomenon. Signs and
    symptoms
    are usually intermittent and mild; very
    rare sequelae include digital ulceration
    and/or soft tissue breakdown.
    Carefully
    observe patients during
    treatment for digital changes. Further
    evaluation may be required, including
    referral.
  • CNS stimulants have been associated
    with weight loss and slowing of
    growth rate in pediatric patients.
    Monitor height and weight
    at
    appropriate intervals in pediatric
    patients. Treatment may need to be
    interrupted in children not growing or
    gaining weight as
    expected.

Adverse Reactions

  • Based on accumulated data from
    other methylphenidate products, the
    most common (>5% and twice the
    rate of placebo)
    adverse reactions are
    appetite decreased, insomnia,
    nausea, vomiting, dyspepsia,
    abdominal pain, weight decreased,
    anxiety,
    dizziness, irritability, affect
    lability, tachycardia, and blood
    pressure increased.

Drug Interactions

  • Adjust dosage of antihypertensive
    drug as needed. Monitor blood
    pressure.
  • Avoid use of AZSTARYS on the day of
    surgery if halogenated anesthetics
    will be used.

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Prescribing Information,
including Boxed WARNING.

INDICATION

AZSTARYS is a central nervous system
(CNS) stimulant indicated for the
treatment of Attention Deficit
Hyperactivity Disorder (ADHD) in
patients 6 years and older.

IMPORTANT SAFETY INFORMATION

WARNING: ABUSE AND DEPENDENCE

  • CNS stimulants, including AZSTARYS, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy