A solid performance in the classroom study

The EVEKEO classroom study included 97 children with ADHD1

Before we tell you the classroom study results, you may be wondering what a classroom study is. Here’s how the researchers explain it:

A laboratory classroom setting for study of ADHD medications allows for assessment by trained observers over the course of a typical extended school day….1*

*This study was a post-approval study. Post-approval studies are used to assess the continued safety and effectiveness of an already approved medication.

How pediatric study patients with ADHD were evaluated

In a classroom study of children ages 6 to 12 years with ADHD, the researchers were looking to see how EVEKEO® CII (amphetamine sulfate tablets, USP) affected the following1:

†The math test was adjusted for the skill level of the child and wasn’t intended to see how well the child could learn math. Instead, it was to assess the child’s level of attention.

The children were evaluated multiple times over a 10-hour span on 2 different classroom days. On one classroom day, they received EVEKEO. On the other classroom day, they received a pill that looks exactly like EVEKEO but doesn't contain any medication, called a placebo. Results from the 2 days were compared to determine not only the effect EVEKEO had on symptoms, but also how long the effect lasted.1

Children who were excluded from the study included those with a primary psychiatric diagnosis other than ADHD, or those with a secondary or co-morbid diagnosis other than ADHD with the exception of simple phobias, oppositional defiance disorders, motor skill disorders, communication disorders, learning disorders, adjustment disorders, and sleep disorders. Others who were excluded from the study were children with clinically significant cognitive impairment or a personal history of seizure disorders (except simple febrile seizures), untreated thyroid disease, glaucoma, Gilles de la Tourette's disorder, or chronic tics, as well as those with a personal history of cardiac disorders, serious cardiac conditions, or severe hypertension.1

PERMP Test Results From a Real Classroom Study Subject With ADHD2



The results

EVEKEO significantly improved performance, behavior, and attention at every measured time point, from 45 minutes to 10 hours.1

  • Improved performance: Children attempted to solve more problems on the PERMP, and answered more problems correctly, after taking EVEKEO compared with placebo (see example below)
  • Improved behavior and attention: When the scores of the 13-item scale were combined, EVEKEO was shown to have significantly improved behavior and attention measured by the SKAMP scale compared with placebo

References: 1. Childress AC, Brams M, Cutler AJ, et al. The efficacy and safety of Evekeo, racemic amphetamine sulfate, for treatment of attention-deficit/hyperactivity disorder symptoms: a multicenter, dose-optimized, double-blind, randomized, placebo-controlled crossover laboratory classroom study. J Child Adolesc Psychopharmacol. 2015;25(5):402-414. 2. Data on file. Arbor Pharmaceuticals, LLC.

IMPORTANT SAFETY INFORMATION

Evekeo (amphetamine sulfate tablets, USP) is a federally controlled substance (CII) with a high risk of abuse or dependence. Keep in a safe place to prevent misuse and abuse. Selling or sharing Evekeo may harm others and is illegal.

INDICATION

Evekeo® (amphetamine sulfate tablets, USP) is a prescription medicine for the treatment of narcolepsy, attention deficit disorder with hyperactivity as an integral part of a total treatment program and exogenous obesity as a short term adjunct in a regimen of weight reduction.

IMPORTANT SAFETY INFORMATION

Evekeo (amphetamine sulfate tablets, USP) is a federally controlled substance (CII) with a high risk of abuse or dependence. Keep in a safe place to prevent misuse and abuse. Selling or sharing Evekeo may harm others and is illegal.

Do not take Evekeo if you or your child:

  • has a history of advanced heart disease or hardening of the arteries, moderate to severe high blood pressure, hyperthyroidism, known hypersensitivity or other serious cardiac problems that may place you or your child at increased vulnerability to the sympathomimetic effects of a stimulant drug
  • is very anxious, tense or agitated
  • has a history of drug abuse
  • is taking or has taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor (MAOI)
  • is sensitive to, allergic to, or had a reaction to other stimulant medicines

Warnings and Precautions

Serious heart problems can occur when taking stimulant medicines, such as Evekeo, and can include:

  • sudden death in people who have heart problems or heart defects
  • sudden death, stroke and heart attack in adults
  • increased blood pressure and heart rate

Tell your doctor if you or your child has any heart problems including heart defects, abnormal heart rhythm, high blood pressure, disease known as cardiomyopathy, coronary artery disease, or a family history of these problems or sudden cardiac death. Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath or fainting while taking Evekeo.

Mental (psychiatric) problems can occur including:

  • new or worse behavior and thought problems
  • new or worse bipolar illness
  • new or worse aggressive behavior or hostility

New aggressive behavior or psychotic symptoms can occur in children and teenagers such as:

  • seeing things or hearing voices
  • believing things that are not true
  • being suspicious
  • new manic problems

Tell your doctor about any drug abuse, alcohol abuse or mental problems that you or your child has had or about a family history of suicide, bipolar illness or depression, new or worsening aggressive behavior or hostility. Call your doctor right away if you or your child has any new or worsening mental symptoms while taking Evekeo.


Circulation problems in fingers and toes:

  • fingers or toes may feel numb, cool, painful
  • fingers or toes may change color from pale, to blue, to red

Tell your doctor if you or your child has any numbness, pain, color change, or sensitivity to temperature in your fingers and toes or a family history of health conditions including circulation problems in fingers and toes. Call your doctor right away if you or your child has any signs of unexplained wounds appearing on fingers and toes while taking Evekeo.


Evekeo may cause serious side effects including:

  • slowing of growth (height and weight) in children, seizures, eyesight changes or blurred vision, and serotonin syndrome. Serotonin syndrome can be life threatening and happens when Evekeo is taken with certain medicines. Symptoms include agitation, hallucinations, coma or other changes in mental status, problems controlling your movements or muscle twitching, fast heartbeat, high or low blood pressure, sweating or fever, nausea or vomiting, diarrhea, and muscle stiffness or tightness

The most common side effects reported with Evekeo include:

  • headache, stomach ache, trouble sleeping, decreased appetite, unpleasant taste, nervousness, dizziness, sexual problems (impotence in males), vomiting, itching, diarrhea or constipation, dry mouth, weight loss, and mood swings

Talk to your doctor if you or your child have side effects that are bothersome or do not go away, if you or your child is pregnant, plan on becoming pregnant, or are breast-feeding, about all health conditions (or a family history of), and about the medicines you or your child take. Your doctor will decide whether Evekeo can be taken with other medicines and if Evekeo is right for your child.

For additional safety information, consult the Evekeo full Prescribing Information and Medication Guide.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.