FDA label 44d07b63-99b3-4c9d-a0fc-935290e76059

WARNING: 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 [see Warnings and Precautions ( 5.1 ), Drug Abuse and Dependence ( 9.2 , 9.3 )] . WARNING: ABUSE AND DEPENDENCE See full prescribing information for complete boxed warning. CNS stimulants, including ADHANSIA XR, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence ( 5.1 , 9.2 , 9.3 ) Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy ( 5.1 , 9.2 )

5 WARNINGS AND PRECAUTIONS Serious Cardiovascular Events: Sudden death has been reported in association with CNS stimulants 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. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmias, or coronary artery disease. ( 5.2 ) Blood Pressure and Heart Rate Increases: Monitor blood pressure and pulse. Consider the benefits and risks in patients for whom an increase in blood pressure or heart rate would be problematic. ( 5.3 ) Psychiatric Adverse Reactions: Use of CNS stimulants may cause psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with pre-existing psychiatric illness. Evaluate for bipolar disorder prior to ADHANSIA XR use. ( 5.4 ) Priapism: 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. ( 5.5 ) Peripheral Vasculopathy, including Raynaud’s Phenomenon: Stimulants used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Careful observation for digital changes is necessary during treatment with ADHD stimulants. ( 5.6 ) Long-Term Suppression of Growth: Monitor height and weight at appropriate intervals in pediatric patients. ( 5.7 ) 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. ( 5.8 ) 5.1 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 [see Drug Abuse and Dependence ( 9.2 , 9.3 )] . 5.2 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. 5.3 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. 5.4 Psychiatric Adverse Reactions Exacerbation of Pre-Existing Psychosis CNS stimulants 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 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). New Psychotic or Manic Symptoms 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. 5.5 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. 5.6 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. 5.7 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. 5.8 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 [see Contraindications ( 4 )] .

6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: Known hypersensitivity to methylphenidate or other ingredients of ADHANSIA XR [see Contraindications ( 4 )] Hypertensive crisis when used concomitantly with monoamine oxidase inhibitors [see Contraindications ( 4 ) and Drug Interactions ( 7.1 )] Drug dependence [see Boxed Warning, Warnings and Precautions ( 5.1 ), and Drug Abuse and Dependence ( 9.2 , 9.3 )] Serious cardiovascular reactions [see Warnings and Precautions ( 5.2 )] Blood pressure and heart rate increases [see Warnings and Precautions ( 5.3 )] Psychiatric adverse reactions [see Warnings and Precautions ( 5.4 )] Priapism [see Warnings and Precautions ( 5.5 )] Peripheral vasculopathy, including Raynaud’s phenomenon [see Warnings and Precautions ( 5.6 )] Long-term suppression of growth [see Warnings and Precautions ( 5.7 )] Allergic Reactions FD&C Yellow No.5 [see Warnings and Precautions ( 5.8 )] The most common (≥5% and twice the rate of placebo) adverse reactions occurring with ADHANSIA XR in adults are insomnia, dry mouth, nausea, 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Purdue Pharma L.P. at 1-888-726-7535 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Clinical Trials Experience with Other Methylphenidate Products in Children, Adolescents, and Adults with ADHD Commonly reported (≥2% of the methylphenidate group and twice the rate of the placebo group) adverse reactions from placebo-controlled trials of methylphenidate products include: appetite decreased, weight decreased, nausea, abdominal pain, dyspepsia, dry mouth, vomiting, insomnia, anxiety, nervousness, restlessness, affect lability, agitation, irritability, dizziness, vertigo, tremor, blurred vision, blood pressure increased, heart rate increased, tachycardia, palpitations, hyperhidrosis, and pyrexia. Clinical Trials Experience with ADHANSIA XR ADHANSIA XR was studied in adults (18 to 72 years) and pediatric patients (6 to 17 years) who met Diagnostic and Statistical Manual of Mental Disorders, 5 th edition (DSM-5) criteria for ADHD. The safety data for adults is based on three randomized, double-blind, placebo-controlled studies in doses of 25 mg to 100 mg per day. The safety data for pediatric patients (6 to 17 years) is based on two randomized, double-blind, placebo-controlled studies in doses of 25 mg to 85 mg per day. The total number of patients exposed to ADHANSIA XR during 1 to 4-week long, controlled treatment periods is 1168; this included 719 adult patients and 449 pediatric patients [156 (6 to 12 years); 293 (12 to 17 years)], from two clinical trials in adults, one in pediatric patients ages 12 to 17 years, and one in pediatric patients ages 6 to 12 years [see Clinical Studies ( 14 )] . Adverse Reactions Leading to Discontinuation of Treatment In controlled adult trials for Study 1, 3% of both of ADHANSIA XR-treated patients and placebo-treated patients discontinued due to adverse reactions. In an adult workplace environment study (Study 2), 10% of ADHANSIA XR-treated patients discontinued due to adverse reactions compared to 0% of placebo-treated patients. The following adverse reactions led to discontinuation at a frequency of 2% of ADHANSIA XR-treated patients: nausea, bronchitis, gastroenteritis viral, viral infection, blood pressure increased, and hypomania. In an adult laboratory classroom study (Study 5), 3.5% of ADHANSIA XR-treated patients discontinued due to adverse reactions during the open-label titration period. There were no discontinuations due to adverse reactions during the double-blind period of the study. 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 that placebo was irritability (1%). Two patients taking ADHANSIA XR 70 or 85 mg had delirium leading to discontinuation. In a controlled trial (Study 4) in pediatric patients (6 to 12 years), 1% of ADHANSIA XR-treated patients discontinued due to adverse reactions compared to 0% of placebo-treated patients. Adult Patients with ADHD The most common adverse reactions (incidence of ≥5% and at least twice placebo) of ADHANSIA XR occurring in controlled trials in adults (Study 1) were insomnia, dry mouth, and decreased appetite. Table 1 lists the adverse reactions that occurred ≥2% of adult patients and greater than placebo among ADHANSIA XR-treated adult patients in Study 1. Table 1: Adverse Reactions Occurring in ≥ 2% of Adult Patients with ADHD on ADHANSIA XR and Greater than Patients Taking Placebo in a 4-week Clinical Trial (Study 1) Adverse Reaction ADHANSIA XR All doses ADHANSIA XR Placebo 25 mg 45 mg 70 mg 100 mg N=375 (N=77) (N=73) (N=73) (N=74) (N=297) (N=78) Initial Insomnia 4% 8% 6% 7% 6% 1% Insomnia 17% 11% 16% 19% 16% 4% Dry mouth 8% 8% 7% 14% 9% 4% Nausea 4% 6% 4% 11% 6% 3% Diarrhea 1% 3% 7% 5% 4% 1% Decreased appetite 4% 7% 15% 19% 11% 3% Feeling jittery 1% 3% 8% 4% 4% 1% Weight decreased 3% 4% 3% 5% 4% 1% Upper respiratory tract infection 0% 4% 3% 3% 2% 1% The most common adverse reactions (incidence of ≥5%) of ADHANSIA XR occurring in adults in the open-label dose-optimization period of Study 5 were headache, decreased appetite, insomnia, irritability, upper respiratory tract infection, dry mouth, nausea, anxiety, and fatigue. Table 2 lists adverse reactions that occurred ≥2% of adult patients in the ADHANSIA XR-treated patients and greater than placebo-treated patients for the double-blind period of study 5. Table 2: Adverse Reactions Occurring in ≥ 2% of Adult Patients with ADHD on ADHANSIA XR and Greater than Patients Taking Placebo in the Double-Blind Period (Study 5) * Includes insomnia, initial insomnia, and delayed sleep phase Adverse Reaction ADHANSIA XR All doses ADHANSIA XR Placebo 25 mg 35 mg 45 mg 55 mg 70 mg 85 mg 100 mg N=239 (N=3) (N=4) (N=15) (N=31) (N=30) (N=22) (N=16) (N=121) (N=118) Headache 0% 0% 7% 0% 3% 5% 13% 4% 3% Fatigue 0% 0% 0% 3% 3% 9% 0% 3% 1% Insomnia* 0% 0% 0% 0% 7% 5% 0% 3% 2% Irritability 0% 0% 0% 0% 0% 9% 0% 2% 0% Nausea 0% 0% 7% 3% 0% 0% 0% 2% 0% Dysmenorrhea 0% 25% 0% 0% 0% 5% 0% 2% 0% Pediatric Patients (12 to 17 years) with ADHD 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. Table 3 lists the adverse reactions that occurred ≥2% of pediatric patients (12 to 17 years) and greater than placebo among ADHANSIA XR-treated pediatric patients (12 to 17 years). Table 3: Adverse Reactions Occurring in ≥ 2% of Pediatric Patients (12 to 17 years) with ADHD Taking ADHANSIA XR and Greater than Placebo in a 4-week Clinical Trial Adverse Reaction ADHANSIA XR All doses ADHANSIA XR Placebo 25 mg 45 mg 70 mg 85 mg (N=73) (N=72) (N=76) (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% Pediatric Patients (6 to 12 years) with ADHD Study 4, conducted in pediatric patients 6 to 12 years of age, was comprised of a 6-week open-label dose-optimization phase in which all patients received ADHANSIA XR (n=156; mean dose 48 mg), followed by a 1-week, double-blind controlled phase in which patients were randomized to continue ADHANSIA XR (n=75) or switch to placebo (n=73). During the open-label ADHANSIA XR treatment phase, adverse reactions reported in > 5% of patients included: decreased appetite (35%), upper abdominal pain (15%), affect lability (13%), nausea or vomiting (13%), weight decreased (12%), insomnia (10%), irritability (10%), headache (10%), and heart rate increased (5%). Because of the trial design (6-week open-label active treatment phase followed by a 1-week, randomized, double-blind, placebo-controlled withdrawal), the adverse reaction rates described in the double-blind phase are lower than expected in clinical practice. No difference occurred in the incidence of adverse reactions between ADHANSIA XR and placebo during the 1-week, double-blind, placebo-controlled treatment phase. 6.2 Post-marketing Experience The following adverse reactions have been identified during post approval use of methylphenidate products. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These adverse reactions are as follows: Blood and Lymphatic System Disorders: pancytopenia, thrombocytopenia, thrombocytopenic purpura Cardiac Disorders: angina pectoris, bradycardia, extrasystole, supraventricular tachycardia, ventricular extrasystole Eye Disorders: diplopia, mydriasis, visual impairment General Disorders: chest pain, chest discomfort, hyperpyrexia Hepatobiliary disorders: hepatocellular injury, acute hepatic failure Immune System Disorders: hypersensitivity reactions such as angioedema, anaphylactic reactions, auricular swelling, bullous conditions, exfoliative conditions, urticarias, pruritus, rashes, eruptions, and exanthemas Investigations: alkaline phosphatase increased, bilirubin increased, hepatic enzyme increased, platelet count decreased, white blood cell count abnormal Musculoskeletal, Connective Tissue and Bone Disorders: arthralgia, myalgia, muscle twitching, rhabdomyolysis Nervous System Disorders: convulsion, grand mal convulsion, dyskinesia, serotonin syndrome in combination with serotonergic drugs Psychiatric Disorders: disorientation, hallucination, hallucination auditory, hallucination visual, libido changes, logorrhea, mania Skin and Subcutaneous Tissue Disorders: alopecia, erythema Urogenital System: priapism Vascular Disorders: Raynaud’s phenomenon

<table ID="t87131910" border="0" width="100%"><caption>Table 1: Adverse Reactions Occurring in &#x2265; 2% of Adult Patients with ADHD on ADHANSIA XR and Greater than Patients Taking Placebo in a 4-week Clinical Trial (Study 1)</caption><colgroup align="center"><col width="12*"/><col width="14*"/><col width="14*"/><col width="14*"/><col width="14*"/><col width="14*"/><col width="14*"/></colgroup><tbody><tr><td styleCode="Toprule Botrule Lrule Rrule"><content styleCode="bold">Adverse Reaction</content></td><td styleCode="Toprule Botrule Lrule Rrule" colspan="4" align="center"><content styleCode="bold">ADHANSIA XR</content></td><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">All doses ADHANSIA XR</content></td><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">Placebo</content></td></tr><tr><td styleCode="Toprule Botrule Lrule Rrule"/><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">25 mg</content></td><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">45 mg</content></td><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">70 mg</content></td><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">100 mg</content></td><td styleCode="Toprule Botrule Lrule Rrule"/><td styleCode="Toprule Botrule Lrule Rrule"/></tr><tr><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">N=375</content></td><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">(N=77)</content></td><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">(N=73)</content></td><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">(N=73)</content></td><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">(N=74)</content></td><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">(N=297)</content></td><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">(N=78)</content></td></tr><tr><td styleCode="Toprule Botrule Lrule Rrule" align="left">Initial Insomnia</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">4%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">8%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">6%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">7%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">6%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">1%</td></tr><tr><td styleCode="Toprule Botrule Lrule Rrule" align="left">Insomnia</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">17%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">11%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">16%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">19%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">16%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">4%</td></tr><tr><td styleCode="Toprule Botrule Lrule Rrule" align="left">Dry mouth</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">8%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">8%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">7%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">14%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">9%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">4%</td></tr><tr><td styleCode="Toprule Botrule Lrule Rrule" align="left">Nausea</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">4%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">6%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">4%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">11%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">6%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">3%</td></tr><tr><td styleCode="Toprule Botrule Lrule Rrule" align="left">Diarrhea</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">1%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">3%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">7%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">5%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">4%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">1%</td></tr><tr><td styleCode="Toprule Botrule Lrule Rrule" align="left">Decreased appetite</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">4%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">7%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">15%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">19%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">11%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">3%</td></tr><tr><td styleCode="Toprule Botrule Lrule Rrule" align="left">Feeling jittery</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">1%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">3%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">8%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">4%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">4%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">1%</td></tr><tr><td styleCode="Toprule Botrule Lrule Rrule" align="left">Weight decreased</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">3%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">4%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">3%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">5%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">4%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">1%</td></tr><tr><td styleCode="Toprule Botrule Lrule Rrule" align="left">Upper respiratory tract infection</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">0%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">4%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">3%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">3%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">2%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">1%</td></tr></tbody></table>

<table ID="Table2AdverseReactionsOccurringIn2O-D97AAB99" border="0" width="100%"><caption>Table 2: Adverse Reactions Occurring in &#x2265; 2% of Adult Patients with ADHD on ADHANSIA XR and Greater than Patients Taking Placebo in the Double-Blind Period (Study 5)</caption><colgroup align="center"><col width="12*"/><col width="14*"/><col width="14*"/><col width="14*"/><col span="4" width="14*"/><col width="14*"/><col width="14*"/></colgroup><tfoot><tr><td colspan="10" align="left">* Includes insomnia, initial insomnia, and delayed sleep phase</td></tr></tfoot><tbody><tr><td styleCode="Toprule Botrule Lrule Rrule" rowspan="2"><content styleCode="bold">Adverse Reaction</content></td><td styleCode="Toprule Botrule Lrule Rrule" colspan="7" align="center"><content styleCode="bold">ADHANSIA XR</content></td><td styleCode="Toprule Botrule Lrule Rrule" rowspan="2" align="center"><content styleCode="bold">All doses ADHANSIA XR</content></td><td styleCode="Toprule Botrule Lrule Rrule" rowspan="2" align="center"><content styleCode="bold">Placebo</content></td></tr><tr><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">25 mg</content></td><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">35 mg</content></td><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">45 mg</content></td><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">55 mg</content></td><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">70 mg</content></td><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">85 mg</content></td><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">100 mg</content></td></tr><tr><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">N=239</content></td><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">(N=3)</content></td><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">(N=4)</content></td><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">(N=15)</content></td><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">(N=31)</content></td><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">(N=30)</content></td><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">(N=22)</content></td><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">(N=16)</content></td><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">(N=121)</content></td><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">(N=118)</content></td></tr><tr><td styleCode="Toprule Botrule Lrule Rrule" align="left">Headache</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">0%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">0%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">7%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">0%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">3%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">5%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">13%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">4%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">3%</td></tr><tr><td styleCode="Toprule Botrule Lrule Rrule" align="left">Fatigue</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">0%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">0%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">0%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">3%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">3%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">9%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">0%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">3%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">1%</td></tr><tr><td styleCode="Toprule Botrule Lrule Rrule" align="left">Insomnia*</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">0%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">0%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">0%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">0%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">7%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">5%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">0%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">3%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">2%</td></tr><tr><td styleCode="Toprule Botrule Lrule Rrule" align="left">Irritability</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">0%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">0%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">0%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">0%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">0%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">9%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">0%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">2%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">0%</td></tr><tr><td styleCode="Toprule Botrule Lrule Rrule" align="left">Nausea</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">0%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">0%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">7%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">3%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">0%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">0%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">0%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">2%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">0%</td></tr><tr><td styleCode="Toprule Botrule Lrule Rrule" align="left">Dysmenorrhea</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">0%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">25%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">0%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">0%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">0%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">5%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">0%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">2%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">0%</td></tr></tbody></table>

<table ID="Table3AdverseReactionsOccurringIn2O-D97B7B46" border="0" width="100%"><caption>Table 3: Adverse Reactions Occurring in &#x2265; 2% of Pediatric Patients (12 to 17 years) with ADHD Taking ADHANSIA XR and Greater than Placebo in a 4-week Clinical Trial</caption><colgroup align="center"><col width="12*"/><col width="14*"/><col width="14*"/><col width="14*"/><col width="14*"/><col width="14*"/><col width="14*"/></colgroup><tbody><tr><td styleCode="Toprule Botrule Lrule Rrule"><content styleCode="bold">Adverse Reaction</content></td><td styleCode="Toprule Botrule Lrule Rrule" colspan="4" align="center"><content styleCode="bold">ADHANSIA XR</content></td><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">All doses ADHANSIA XR</content></td><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">Placebo</content></td></tr><tr><td styleCode="Toprule Botrule Lrule Rrule"/><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">25 mg</content></td><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">45 mg</content></td><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">70 mg</content></td><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">85 mg</content></td><td styleCode="Toprule Botrule Lrule Rrule"/><td styleCode="Toprule Botrule Lrule Rrule"/></tr><tr><td styleCode="Toprule Botrule Lrule Rrule"/><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">(N=73)</content></td><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">(N=72)</content></td><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">(N=76)</content></td><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">(N=72)</content></td><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">(N=293)</content></td><td styleCode="Toprule Botrule Lrule Rrule" align="center"><content styleCode="bold">(N=74)</content></td></tr><tr><td styleCode="Toprule Botrule Lrule Rrule" align="left">Decreased appetite</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">7%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">19%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">28%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">26%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">20%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">0%</td></tr><tr><td styleCode="Toprule Botrule Lrule Rrule" align="left">Insomnia</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">4%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">0%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">9%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">13%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">6%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">1%</td></tr><tr><td styleCode="Toprule Botrule Lrule Rrule" align="left">Initial Insomnia</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">4%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">7%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">5%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">4%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">5%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">1%</td></tr><tr><td styleCode="Toprule Botrule Lrule Rrule" align="left">Weight decreased</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">1%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">3%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">8%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">13%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">7%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">0%</td></tr><tr><td styleCode="Toprule Botrule Lrule Rrule" align="left">Abdominal pain upper</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">5%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">1%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">5%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">4%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">4%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">1%</td></tr><tr><td styleCode="Toprule Botrule Lrule Rrule" align="left">Nausea</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">3%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">6%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">7%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">8%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">6%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">4%</td></tr><tr><td styleCode="Toprule Botrule Lrule Rrule" align="left">Dizziness</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">3%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">0%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">4%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">4%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">3%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">0%</td></tr><tr><td styleCode="Toprule Botrule Lrule Rrule" align="left">Dry mouth</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">1%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">0%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">5%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">4%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">3%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">1%</td></tr><tr><td styleCode="Toprule Botrule Lrule Rrule" align="left">Vomiting</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">1%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">1%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">3%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">6%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">3%</td><td styleCode="Toprule Botrule Lrule Rrule" align="center">0%</td></tr></tbody></table>