Cotempla XR-ODT Laboratory Classroom Study

The efficacy, safety, and tolerability of Cotempla XR-ODT were evaluated in a Phase 3, randomized, multicenter, double-blind, placebo-controlled study conducted in 87 pediatric patients aged 6 to 12 years with ADHD.

Investigators evaluated the attention and behavior of subjects using the SKAMP* rating scale. The SKAMP rating scale is a validated 13-item scale, with scores ranging from 0 to 78. A lower SKAMP score indicates less symptomology.

*Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) rating scale

Significant improvement of SKAMP combined scores with Cotempla XR-ODT

The primary efficacy endpoint was the average of all SKAMP-Combined scores for Cotempla XR-ODT vs placebo over the classroom testing day.

The SKAMP-Combined scores test day average was statistically significantly lower (improved) with Cotempla XR-ODT compared to placebo (difference of -11 (95% CI: -13.9, -8.2)).

Cotempla XR-ODT

Cotempla XR-ODT Works Fast

One of the key secondary efficacy endpoints was the onset of effect, defined as the first time point measured at which Cotempla XR-ODT separates from placebo on the SKAMP-Combined scores.

At hour 1, the first time point tested, Cotempla XR-ODT demonstrated significant improvement in ADHD symptoms. Cotempla XR-ODT score of 10.5 vs placebo of 21.2 (difference of -10.7 P<0.0001).1

Cotempla XR-ODT

Improvement in ADHD Symptoms Throughout the Day—from the early morning through homework time

Another key secondary efficacy endpoint was the duration of effect, defined as the last time point at which Cotempla XR-ODT separates from placebo on the SKAMP-Combined scores.

The SKAMP-Combined scores were also statistically significantly lower (improved) at time points (1, 3, 5, 7, 10, 12 hours) post-dosing with COTEMPLA XR-ODT compared to placebo. The efficacy was maintained through 12 hours postdose.

Cotempla XR-ODT
Cotempla XR-ODT
Important Safety Information
WARNING: ABUSE AND DEPENDENCE
CNS stimulants, including Cotempla XR-ODT, 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 methylphenidate or other ingredients in Cotempla XR-ODT. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate products.
  • Concomitant treatment with monoamine oxidase inhibitors (MAOIs), and also within a minimum of 14 days following discontinuation of treatment with a MAOI. Hypertensive crisis can occur.
Warnings and Precautions
  • Serious Cardiovascular Reactions: Sudden death, stroke and myocardial infarction have occurred in adults treated with CNS stimulants at recommended doses. Sudden death has occurred in pediatric patients with structural cardiac abnormalities and other serious cardiac problems, and in adults taking CNS stimulants at recommended doses for ADHD. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, and other serious heart problems. Perform further evaluation on patients who develop exertional chest pain, unexplained syncope, or arrhythmias during Cotempla XR-ODT treatment.
  • Blood Pressure and Heart Rate Increases: CNS stimulants cause an increase in blood pressure (mean increase approximately 2 to 4 mm Hg) 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, and may induce a manic or mixed episode in patients with bipolar disorder. Prior to initiating treatment, screen patients for risk factors for developing a manic episode. CNS stimulants may cause psychotic or manic symptoms in patients without a prior history of psychotic illness or mania. If such symptoms occur, consider discontinuing Cotempla XR-ODT.
  • Priapism: Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate products in both pediatric and adult patients. Patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.
  • Peripheral Vasculopathy, including Raynaud’s Phenomenon: CNS stimulants 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. Careful observation for digital changes is necessary.
  • Long-Term Suppression of Growth: CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Closely monitor weight and height in pediatric patients treated with Cotempla XR-ODT. Treatment may need to be interrupted.

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.

Pregnancy and Lactation

CNS stimulants, such as Cotempla XR-ODT, can cause vasoconstriction and thereby decrease placental perfusion. No fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Cotempla XR-ODT and any potential adverse effects on the breastfed child from Cotempla XR-ODT or from the underlying maternal condition. Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain.


INDICATION

Cotempla XR-ODT is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age.

Please click here for Full Prescribing Information.


References
  1. Childress AC, Kollins SH, Cutler AJ, Marraffino A, Sikes CR. Efficacy, safety, and tolerability of an extended‑release orally disintegrating methylphenidate tablet in children 6‑12 years of age with attention‑deficit/hyperactivity disorder in the laboratory classroom setting. J Child Adolesc Psychopharmacol. 2017;27(1):66-74.
  2. Data on file. Neos Therapeutics, Inc..
WARNING: ABUSE AND DEPENDENCE
CNS stimulants, including Cotempla XR-ODT, 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 methylphenidate or other ingredients in Cotempla XR-ODT. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate products.
  • Concomitant treatment with monoamine oxidase inhibitors (MAOIs), and also within a minimum of 14 days following discontinuation of treatment with a MAOI. Hypertensive crisis can occur.
Warnings and Precautions
  • Serious Cardiovascular Reactions: Sudden death, stroke and myocardial infarction have occurred in adults treated with CNS stimulants at recommended doses. Sudden death has occurred in pediatric patients with structural cardiac abnormalities and other serious cardiac problems, and in adults taking CNS stimulants at recommended doses for ADHD. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, and other serious heart problems. Perform further evaluation on patients who develop exertional chest pain, unexplained syncope, or arrhythmias during Cotempla XR-ODT treatment.
  • Blood Pressure and Heart Rate Increases: CNS stimulants cause an increase in blood pressure (mean increase approximately 2 to 4 mm Hg) 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, and may induce a manic or mixed episode in patients with bipolar disorder. Prior to initiating treatment, screen patients for risk factors for developing a manic episode. CNS stimulants may cause psychotic or manic symptoms in patients without a prior history of psychotic illness or mania. If such symptoms occur, consider discontinuing Cotempla XR-ODT.
  • Priapism: Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate products in both pediatric and adult patients. Patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.
  • Peripheral Vasculopathy, including Raynaud’s Phenomenon: CNS stimulants 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. Careful observation for digital changes is necessary.
  • Long-Term Suppression of Growth: CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Closely monitor weight and height in pediatric patients treated with Cotempla XR-ODT. Treatment may need to be interrupted.

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.

Pregnancy and Lactation

CNS stimulants, such as Cotempla XR-ODT, can cause vasoconstriction and thereby decrease placental perfusion. No fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Cotempla XR-ODT and any potential adverse effects on the breastfed child from Cotempla XR-ODT or from the underlying maternal condition. Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain.


INDICATION

Cotempla XR-ODT is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age.

Please click here for Full Prescribing Information.


References
  1. Childress AC, Kollins SH, Cutler AJ, Marraffino A, Sikes CR. Efficacy, safety, and tolerability of an extended‑release orally disintegrating methylphenidate tablet in children 6‑12 years of age with attention‑deficit/hyperactivity disorder in the laboratory classroom setting. J Child Adolesc Psychopharmacol. 2017;27(1):66-74.
  2. Data on file. Neos Therapeutics, Inc..