azstarys-pro.com Open in urlscan Pro
13.225.87.35  Public Scan

Form analysis
0 forms found in the DOM

Text Content

 * for US HEALTHCARE PROFESSIONALS only
 * Prescribing Information
 * Patient Site

 * d-MPH/SDX
   Prodrug Technology
 * Efficacy Throughout
   the Day
 * Once-Daily
   Dosing
 * Safety
   Profile
 * Savings and
   Support
    * Copay Savings
    * Download Resources

 * Connect
   With Us
    * Speak With a
      Sales Representative
    * Speak With a Medical
      Science Liaison
    * Register for Updates

 * About Corium
 * Privacy Policy
 * Terms of Use
 * Contact Us


AZSTARYS PROVIDES A UNIQUE APPROACH TO SYMPTOM COVERAGE1,2


WITH AN IR D-MPH AND
SDX PRODRUG, AZSTARYS
PROVIDES EFFICACY
THROUGHOUT THE DAY1

Improvement in ADHD symptoms was demonstrated using SKAMP, a 13-item validated
assessment of classroom behaviors in children with ADHD,1 including3,4,a

 * Attention
 * Deportment
 * Quality of
   written work
 * Compliance


AZSTARYS SIGNIFICANTLY LOWERED
SKAMP-C SCORES AVERAGED OVER
THE 13-HOUR CLASSROOM DAY1



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


RAPID ONSET AND EXTENDED DURATION OF
EFFICACY WITH A ONCE-DAILY DOSE1


VIEW STUDY DESIGN1

The efficacy of AZSTARYS was evaluated in a randomized,
double-blind, placebo-controlled, parallel-group, analog
classroom study of 150 pediatric patients (aged 6-12 years) who
were diagnosed with ADHD.

Screening and washout

Open-label dose-optimization period (3 weeks)

 * AZSTARYS 39.2 mg/7.8 mg administered once daily in the morning
 * The dose could be titrated weekly to either 26.1 mg/5.2 mg, 39.2 mg/7.8 mg,
   or 52.3 mg/10.4 mg until an optimal dose or the maximum dose (52.3 mg/10.4
   mg) was reached

Treatment period (1 week)

 * Patients were randomly assigned to either continue receiving the individually
   optimized dose of AZSTARYS or placebo

Raters evaluated the attention and behavior of patients in a laboratory
classroom setting over 13 hours using the SKAMP-C rating scale. SKAMP is a
validated, 13-item, teacher-rated scale that assesses ADHD symptoms in a
classroom setting

Primary end point: mean change from baseline (predose at
randomization visit) of the SKAMP-C scores averaged across the
test day (not including baseline score), with assessments conducted
at 0.5, 1, 2, 4, 8, 10, 12, and 13 hours post dose.


THE FIRST AND ONLY SDX PRODRUG
DESIGNED FOR CONTINUOUS
CONVERSION TO D-MPH

Discover SDX technology


FLEXIBLE AND CONVENIENT
DOSING AND ADMINISTRATION

See AZSTARYS dosing

d-MPH, dexmethylphenidate; IR, immediate-release; LS, least squares; SDX,
serdexmethylphenidate; SKAMP, Swanson, Kotkin, Agler, M-Flynn, and Pelham;
SKAMP-C, Swanson, Kotkin, Agler, M-Flynn, and Pelham-Combined.

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. Wigal SB, Wigal TL. The laboratory
school protocol: its origin, use, and new
applications. J Atten Disord.
2006;10(1):92-111.
doi:10.1177/1087054705286049 4. Wigal SB.
Laboratory school protocol mini-review: use of
direct observational and objective measures to
assess ADHD
treatment response across the
lifespan. Front Psychol. 2019;10:1796. doi:10.3389/
fpsyg.2019.01796 5. Data on file; Corium, Inc.


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, and 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.

Please click here for Full
Prescribing Information,
including Boxed WARNING.

 * About Corium
 * Privacy Policy
 * Terms of Use
 * Contact Us

© 2021 Corium Inc. All Rights Reserved.

COM-AZS-000788 06/21

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