Clinical Data in
Adolescent Patients

Help your patients meet the demands
of their school day and their daily tasks

For your patients who require an extended‑release methylphenidate product, Adhansia XR significantly improved ADHD symptoms in patients 12‑17 years.1*

*4-week randomized, double-blind, multi-center, placebo-controlled, safety and efficacy study in 354 pediatric patients (12-17 years) with ADHD. Primary endpoint: Change from baseline of the pediatric ADHD-5-Rating Scale total score from baseline (Visit 2, Week 1) to Visit 6, Week 5. Adhansia XR demonstrated a statistically significant treatment effect compared to placebo at Visit 6, Week 5 for the 45 and 70 mg dose groups.1

STUDY 3:

Symptom Evaluation in Adolescents with ADHD1,2

STUDY DESIGN1,2

Description: A 4-week randomized, double-blind, multi-center, placebo-controlled, safety and efficacy study involving 354 pediatric patients (12 to 17 years) who met the DSM-5 criteria for ADHD.1

Patients were randomized to one of five treatment arms with Adhansia XR 25, 45, 70, or 85 mg or placebo. Doses were titrated over a 2-week period and then maintained on the fixed dose for an additional 2 weeks.1

Primary endpoint: Change from baseline (Visit 2, Week 1) of the pediatric ADHD-5-RS total score at the end of the final evaluation visit (Visit 6, Week 5) vs. placebo.1

DOUBLE-BLIND PHASE2

Study 3 study design Study 3 study design

ADHD-5-RS=ADHD Rating Scale 5; DSM-5=Diagnostic and Statistical Manual of Mental Disorders, 5th Edition

PATIENT DEMOGRAPHICS2

Study 3 patient demographics Study 3 patient demographics

*Combined=inattentive and hyperactive/impulsive

Improved ADHD symptoms in adolescents vs. placebo1,2

Study 3: Adhansia XR improved symptoms in adolescents (12-17 years) vs. placebo, as measured by change in pediatric ADHD-5-RS total score from baseline (Visit 2, Week 1) to Visit 6, Week 51

  • Significant improvements were seen at doses of 45 and 70 mg.

PRIMARY EFFICACY RESULTS1,2

Study 3 primary endpoint

The ADHD-5-RS is an 18-question clinician-administered scale that assesses inattentive and hyperactive-impulsive symptoms and their severity based on the DSM-5 diagnostic criteria for ADHD.2

n=number of subjects in the primary efficacy analysis set; LS=least squares; SE=standard error; CI=95% confidence interval, not adjusted for multiple comparisons.1

*Statistically significantly different from placebo after adjusting for multiplicity.1

Difference (drug minus placebo) in LS mean change from baseline.1

Most common adverse reactions
& discontinuation rates1

In short-term controlled trials in pediatric patients, efficacy was demonstrated at dosages of 70 mg daily, but dosages ≥70 mg daily were associated with a disproportionate increase in the incidence of certain adverse reactions.1

The most common (incidence ≥5% and at least twice placebo) adverse reactions reported in pediatric patients (12 to 17 years) were decreased appetite, insomnia, and weight decreased.1

In a controlled trial (Study 3) in pediatric patients (12 to 17 years), 3% of Adhansia XR-treated patients discontinued due to adverse reactions compared to 0% of placebo-treated patients. The most frequent adverse reactions leading to discontinuation in at least 1% of Adhansia XR-treated patients and at a rate greater than placebo was irritability (1%). Two patients taking Adhansia XR 70 or 85 mg had delirium leading to discontinuation.1

ADVERSE REACTIONS OCCURRING IN ≥2% OF PEDIATRIC PATIENTS (12-17 YEARS)
WITH ADHD TAKING ADHANSIA XR AND GREATER THAN PLACEBO IN A 4-WEEK
CLINICAL TRIAL (STUDY 3, N=367)1

ADVERSE REACTION ADHANSIA XR ADHANSIA XR
ALL DOSES
PLACEBO
25 mg
(N=73)
45 mg
(N=72)
70 mg
(N=76)
85 mg
(N=72)
(N=293) (N=74)
Decreased appetite 7% 19% 28% 26% 20% 0%
Insomnia 4% 0% 9% 13% 6% 1%
Initial insomnia 4% 7% 5% 4% 5% 1%
Weight decreased 1% 3% 8% 13% 7% 0%
Abdominal pain upper 5% 1% 5% 4% 4% 1%
Nausea 3% 6% 7% 8% 6% 4%
Dizziness 3% 0% 4% 4% 3% 0%
Dry mouth 1% 0% 5% 4% 3% 1%
Vomiting 1% 1% 3% 6% 3% 0%

The drugs known to have clinically important interactions with Adhansia XR are monoamine oxidase inhibitors (MAOIs) and gastric pH modulators.1

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Important Safety Information

Contraindications

Adhansia XR is contraindicated in patients with a known hypersensitivity to methylphenidate or other components of Adhansia XR. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other methylphenidate products. Adhansia XR is also contraindicated in patients receiving concomitant treatment with monoamine oxidase inhibitors (MAOIs), and also within 14 days following discontinuation of treatment with a MAOI, because of the risk of hypertensive crisis.

Warnings and Precautions

Potential for Abuse and Dependence

CNS stimulants, including Adhansia XR, 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.

Serious Cardiovascular Events

Sudden death, stroke and myocardial infarction have occurred in adults treated with CNS stimulant treatment at recommended doses. Sudden death has occurred in pediatric patients with structural cardiac abnormalities and other serious cardiac problems taking CNS stimulants at recommended doses for ADHD. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during Adhansia XR treatment.

Blood Pressure and Heart Rate Increases

CNS stimulants cause an increase in blood pressure (mean increase approximately 2 to 4 mmHg) and heart rate (mean increase approximately 3 to 6 bpm). Individuals may have larger increases. Monitor all patients for hypertension and tachycardia.

Psychiatric Adverse Reactions

CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.

CNS stimulants may induce a manic or mixed episode in patients. Prior to initiating treatment, screen patients 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).

CNS stimulants, at recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic illness or mania. If such symptoms occur, consider discontinuing Adhansia XR. In a pooled analysis of multiple short-term, placebo-controlled studies of CNS stimulants, psychotic or manic symptoms occurred in approximately 0.1% of CNS stimulant-treated patients, compared to 0% in placebo-treated patients.

Priapism

Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate products, in both pediatric and adult patients. Priapism was not reported with drug initiation but developed after some time on the drug, often subsequent to an increase in dose. Priapism has also appeared during a period of drug withdrawal (drug holidays or during discontinuation). Patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.

Peripheral Vasculopathy, including Raynaud's Phenomenon

CNS stimulants, including Adhansia XR, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud's phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud's phenomenon, were observed in post-marketing reports at different times and at therapeutic doses in all age groups throughout the course of treatment. Signs and symptoms generally improve after reduction in dose or discontinuation of drug. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.

Long-Term Suppression of Growth

CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients.

Careful follow-up of weight and height in pediatric patients ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated pediatric patients over 36 months (to the ages of 10 to 13 years), suggests that consistently medicated pediatric patients (i.e., treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development.

Closely monitor growth (weight and height) in pediatric patients treated with CNS stimulants, including Adhansia XR. Patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.

Allergic-Type Reactions FD&C Yellow No. 5

Adhansia XR 45 mg capsules contain FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

Adverse Reactions

The most common (≥5% and twice the rate of placebo) adverse reactions occurring with Adhansia XR in adults are insomnia, dry mouth, and decreased appetite.

The most common (≥5% and twice the rate of placebo) adverse reactions occurring with Adhansia XR in pediatric patients are decreased appetite, insomnia, and weight decreased.

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Adhansia XR during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-23881-866-961-2388.

To report SUSPECTED ADVERSE REACTIONS, contact Purdue Pharma L.P. at 1-888-726-75351-888-726-7535 or FDA at 1-800-FDA-10881-800-FDA-1088 or www.fda.gov/medwatch.

Please read Full Prescribing Information, including Boxed Warning.

References: 1. Adhansia XR™ (methylphenidate HCl) prescribing information. Stamford, CT: Purdue Pharma L.P. 2. Data on file. Purdue Pharma L.P. Stamford, CT.

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