CONCERTA(R) in the Classroom: New Data on Attention in Children With ADHD

LAS VEGAS, Nov. 4 /PRNewswire/ -- New findings presented today show that CONCERTA® (OROS® methylphenidate HCl Extended-Release Tablets CII) is the only stimulant medication with data that demonstrate a significant treatment effect on attention at one hour and through 12.5 hours in children with Attention Deficit Hyperactivity Disorder (ADHD). ADHD is a common and treatable medical condition characterized by inattention, hyperactivity and impulsivity(1) that is estimated to affect about 5 million children(2) in the United States.

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McNeil Pediatrics(TM), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., presented the data at the U.S. Psychiatric and Mental Health Congress (Poster 303: Time Course of Treatment Effect of Concerta® [OROS® Methylphenidate] in Children with ADHD).

This is the first data set from new studies that examine the effect of CONCERTA® in a laboratory school, or simulated classroom, setting. The data presented today provide new information on CONCERTA® onset and offset of action in the treatment of children (aged 9 to 12 years) with ADHD.

"Untreated ADHD symptoms can present challenges throughout a child's day, so new findings on onset and duration of effect are important to understand," said Matthew Brams*, M.D., a practicing psychiatrist in Houston, Clinical Assistant Professor at Baylor College of Medicine and an investigator who participated in one of the studies. "There's benefit in medication that acts quickly and lasts through the day, providing treatment coverage when a child may need it in the early morning, through the activities of the day and into the early evening hours."

The results presented today showed significant improvements in attention with CONCERTA® versus placebo as measured by a validated, time-sensitive math test administered throughout the day.

At one hour post-dose, subjects who received CONCERTA® attempted 38 percent more math problems compared with baseline (from 75.8 problems attempted before treatment to 104.4 problems attempted after treatment), while those receiving placebo showed no change from baseline (from 80.6 problems attempted before treatment to 80 problems attempted after treatment).

The results were statistically significant throughout the study's interim time points, from the first testing point at one hour after dosing (p<0.0001) through to the final assessment at 12.5 hours (p<0.0001). Accuracy, as measured by percentage of problems correct, was similar for both treatment groups and was consistent across the period of observation (placebo, 92.1 percent to 93.5 percent and CONCERTA®, 94.0 percent to 94.3 percent).

Adverse events in the study were consistent with those previously reported for CONCERTA®. Adverse events reported by 5 percent or more of the patients during the study included decreased appetite, abdominal pain, headache, irritability, initial insomnia, nasal congestion, pyrexia and dizziness. No subject discontinued because of adverse events, and no serious adverse events or deaths were reported.

*Matthew Brams, M.D., is a paid consultant and speaker for McNeil Pediatrics(TM), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

About the Poster
This is the first data set from two randomized, double-blind, placebo-controlled, crossover analog simulated-classroom trials examining CONCERTA® versus placebo. These studies include a wide range of endpoints based on standardized ADHD measurements, which were tested in a simulated classroom environment, as well as observational input from subjects' parents, teachers and physicians.

"These studies were designed to assess clinically significant improvements in attention, behavior and cognition using a wide range of measures," said H. Lynn Starr, M.D., Director of Medical Affairs for Ortho-McNeil Janssen Scientific Affairs, LLC, and lead author of the poster. "The data presented today provide new insights for healthcare professionals to consider when choosing a medication for children with ADHD."

The primary endpoint analysis in the data set presented today evaluated the onset and duration of effect of CONCERTA® among a representative population of 78 children with ADHD, using a timed mathematical problem-solving measurement known as Permanent Product Measure of Performance, or PERMP.

PERMP is a validated, time sensitive, skill-adjusted math test designed to evaluate a subject's ability to attend, initiate and complete written seatwork. This test was designed to show increase in productivity or attention to detail but does not assess a child's ability to learn math. This data set reflected two components of the PERMP assessment: math problems attempted (PERMP-A) and completed correctly (PERMP-C) within a series of 10-minute time periods. Assessments were performed 30 minutes before the first dose of CONCERTA® or placebo, and periodically throughout the school day simulated in the study.

In these findings, 9- to-12-year-old children who were previously untreated or sub-optimally treated for ADHD received CONCERTA®, which was increased until an optimal individualized dose was achieved (to a maximum of 54 mg/day) over one to six weeks. Children were treated with the optimal dose or placebo in the two separate days of the double-blind, randomized, simulated classroom setting.

About ADHD
Attention Deficit Hyperactivity Disorder (ADHD) is a common and treatable medical condition characterized by inattention, hyperactivity and impulsivity(3) that is estimated to affect about 5 million children(4) and 8 million adults in the U.S.(5) Among other symptoms, a person with ADHD may have trouble sitting still, finishing tasks or following directions.(6) While the exact cause of the condition is still unknown, scientists have focused their research on chemical messengers, or neurotransmitters, in the brain.(6) These messengers are believed to play a role in behaviors like attention and movement.(6) Much like height or eye color, ADHD can be inherited.(6) Studies suggest that 76 percent of ADHD is linked to family genetics.(7) So the condition is more common among people who have a close relative with ADHD.(8) Adults with ADHD have a 50 percent chance of passing it on to their children.(9)

About McNeil Pediatrics(TM)
McNeil Pediatrics(TM), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is committed to meeting the needs of children, adolescents, adults and healthcare professionals through the development of therapies specifically formulated for children, adolescents and adults. McNeil Pediatrics(TM) is a leader in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and markets a leading medication prescribed in the United States for children, adolescents and adults with ADHD. The company is headquartered in Titusville, NJ. Visit www.McNeilPediatrics.net for more information.

About CONCERTA®
CONCERTA® is a prescription product approved for the treatment of attention deficit hyperactivity disorder (ADHD) in children, adolescents and adults ages 6 to 65, as part of a total treatment program that may include counseling or other therapies.

IMPORTANT SAFETY INFORMATION
Talk to your healthcare professional for a proper diagnosis and treatment of ADHD. Only a healthcare professional can decide whether medication is right for you or your child.

CONCERTA® should not be taken by patients who have: allergies to methylphenidate or other ingredients in CONCERTA®; significant anxiety, tension, or agitation; glaucoma; tics, Tourette's syndrome, or family history of Tourette's syndrome; current or past use of monoamine oxidase inhibitor (MAOI); esophagus, stomach, or intestinal narrowing. Children under 6 years of age should not take CONCERTA®.

Abuse of methylphenidate may lead to dependence. Tell your healthcare professional if you or your child has had problems with alcohol or drugs; has had any heart problems, heart defects, high blood pressure, or a family history of these problems; has had depression, abnormal thoughts or visions, bipolar disorder, or seizure. Contact your healthcare professional immediately if you or your child: develops abnormal thinking or hallucinations, abnormal or extreme moods and/or excessive activity; or if aggressive behavior or hostility develops or worsens while taking CONCERTA®. Your child's healthcare professional should check height and weight often and may interrupt CONCERTA® treatment if your child is not growing or gaining weight as expected.

Stimulants may impair the ability of the patient to operate potentially hazardous machinery or vehicles. Caution should be used accordingly until you are reasonably certain that CONCERTA® does not adversely affect your ability to engage in such activities.

The most common adverse reaction (>5%) reported in children and adolescents was upper abdominal pain. The most common adverse reactions (>10%) reported in adults were dry mouth, nausea, decreased appetite, headache, and insomnia.

Visit http://www.concerta.net/concerta/pages/full.jsp for complete Prescribing Information.

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.

CONCERTA® and OROS® are registered trademarks of ALZA Corporation.

(1) National Institute of Mental Health. Attention Deficit Hyperactivity Disorder (ADHD). Web site: http://www.nimh.nih.gov/health/topics/attention-deficit-hyperactivity-disorder-adhd/index.shtml.

(2) Centers for Disease Control and Prevention. ADHD: Data and Statistics. Web site: http://www.cdc.gov/ncbddd/adhd/data.html.

(3) National Institute of Mental Health. Attention Deficit Hyperactivity Disorder (ADHD). Web site: http://www.nimh.nih.gov/health/topics/attention-deficit-hyperactivity-disorder-adhd/index.shtml.

(4) Centers for Disease Control and Prevention. ADHD: Data and Statistics. Web site: http://www.cdc.gov/ncbddd/adhd/data.html.

(5) Adler, Lenard. "Scattered Minds Hope and Help for Adults with Attention Deficit Hyperactivity Disorder." New York: Perigee Trade, 2007.

(6) Mayo Clinic. Attention Deficit Hyperactivity Disorder. Web site: http://www.mayoclinic.com/health/adhd/DS00275/ .

(7) Faraone, S.V., Perlis, R.H., Doyle, A.E., Smoller, J.W., Goralnick, J.J., Holmgren, M.A. and Sklar, P. (2005) Molecular genetics of attention-deficit/hyperactivity disorder. Biological Psychiatry, 57, 1313-1323.

(8) Faraone, S.V. and Biederman, J. Is ADHD Familial? Harvard Review of Psychiatry, January/February 2004.

(9) Zeigler, Chris A., ed. "CHADD Educators Manual on Attention Deficit Hyperactivity Disorder." Lynchburgh: Progress Printing, 2006.

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