New Data Analyses of CONCERTA(R) Efficacy on ADHD in the Classroom

Clinical trial in a simulated classroom "laboratory school" setting evaluated treatment efficacy on ADHD symptoms and specific challenges

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McNeil Pediatrics, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

May 25, 2010, 04:00 ET

NEW ORLEANS, May 25 /PRNewswire/ -- Turning in assignments, following instructions and focusing on learning something new are among the daily classroom challenges for children with Attention Deficit Hyperactivity Disorder (ADHD),(1) according to the National Institute of Mental Health (NIMH). New data presented today show efficacy of CONCERTA® (OROS® methylphenidate HCl Extended-Release Tablets CII) on ADHD symptoms in children with the condition who also may face other specific challenges.

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CONCERTA® efficacy in treating ADHD symptoms in the presence of a comorbid learning disability was demonstrated in data announced at a major medical meeting here by Ortho-McNeil Janssen Scientific Affairs, L.L.C., supporting McNeil Pediatrics™, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. In a separate analysis, treatment with CONCERTA® was associated with significant differences in tests of reading fluency and of reading comprehension.

The new data are two analyses of randomized, double-blind, placebo-controlled studies that examined CONCERTA® efficacy in patients in a simulated classroom environment.

Effects of OROS® Methylphenidate Treatment on Behavior and Performance in Children with ADHD with and without Learning Disability (Poster NR5-8)

The effect of CONCERTA® on behavior and performance were evaluated in 139 patients with ADHD, ages 9 to 12. In addition to a confirmed diagnosis of ADHD, approximately one-third of patients had verbal- or math-based learning disability. Significant improvements were seen in patients who received CONCERTA®, both in those with and those without a comorbid learning disability.

"The NIMH estimates approximately 20 to 30 percent of children with ADHD may be challenged by the presence of a coexisting learning disability, and we wanted to evaluate the efficacy of CONCERTA® on ADHD symptoms in children with this comorbidity," said H. Lynn Starr, M.D., Director of Medical Affairs for Ortho-McNeil Janssen Scientific Affairs, L.L.C., and lead author of Poster NR5-8.

"These are the first data, to our knowledge, using a double-blind, placebo-controlled, laboratory school study design to demonstrate significant efficacy of a stimulant in reducing ADHD symptoms in children with ADHD, with or without a comorbid learning disability," Dr. Starr noted. "We hope this new insight is helpful for parents and healthcare professionals as they consider this treatment need."

Two measurements were used to evaluate CONCERTA® efficacy: the Permanent Product Measure of Performance (PERMP), which evaluates attention using a series of math problems (number of problems attempted and number of problems correct), and the Swanson, Kotkin, Agler, M-Flynn and Pelham (SKAMP) rating scale that evaluates classroom attention and behavior.

PERMP measurements showed patients attempted and completed significantly more math problems when taking CONCERTA®, compared with when taking placebo (p<0.0001). Similar patterns were seen in SKAMP scores, with significant improvement in behavior and attention (p<0.0001).

Adverse events in 10 percent or more of patients were consistent with those previously reported for CONCERTA® and included headache, upper abdominal pain, decreased appetite, irritability and initial insomnia. No serious adverse events or deaths were reported.

Effect of OROS® Methylphenidate Treatment on Reading Performance in Children with ADHD (Poster NR5-19)

CONCERTA® treatment effect was evaluated on reading performance in 78 patients with ADHD, ages 9 to 12. The analysis demonstrated improvement on tests of oral reading fluency and silent reading comprehension with CONCERTA® treatment.

The analysis used two tests that measure reading skills: the Dynamic Indicators of Basic Early Literacy Skills (DIBELS), which measures reading rate, and the Gray Silent Reading Test (GSRT), which evaluates reading comprehension and accuracy.

The average DIBELS score for patients when taking CONCERTA® was higher than when taking placebo, indicating significantly greater accuracy and a faster reading rate (p=0.0092). Patients also demonstrated a significant improvement in reading comprehension (p=0.0038) with GSRT scores consistent with the silent reading comprehension ability of children in a normative population.

Adverse events in 5 percent or more of patients were consistent with those previously reported for CONCERTA® and included decreased appetite, upper abdominal pain, headache, irritability, initial insomnia, dizziness, nasal congestion and pyrexia (elevated temperature). No serious adverse events or deaths were reported.

About ADHD

Attention Deficit Hyperactivity Disorder (ADHD) is a common and treatable medical condition characterized by inattention, hyperactivity and impulsivity(2) that is estimated to affect about 5 million children(3) and 8 million adults in the United States.(4) 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) Studies suggest that 76 percent of ADHD is linked to family genetics,(5) so the condition may be more common among people who have a close relative with ADHD.(6) Adults with ADHD have a 50 percent chance of passing it on to their children.(7)

About Ortho-McNeil Janssen Scientific Affairs, L.L.C.

Ortho-McNeil Janssen Scientific Affairs, L.L.C. is a member of the Johnson & Johnson family of companies. Johnson & Johnson is the world's largest manufacturer of healthcare products serving the consumer, pharmaceutical, and professional markets.

About McNeil Pediatrics™

McNeil Pediatrics™, 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™ is a leader in the treatment of ADHD and markets a leading medication prescribed in the United States for children, adolescents and adults with ADHD. The company is headquartered in Titusville, N.J. Visit www.McNeilPediatrics.net for more information.

About CONCERTA®

CONCERTA® is a prescription medication 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 (greater than 5 percent) reported in children and adolescents was upper abdominal pain. The most common adverse reactions (greater than 10 percent) 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. Bethesda (MD); National Institute of Mental Health, US Department of Health and Human Services; 2008. (NIH Publication Number: NIH 3572). Page 2 of 28 pages.
(2) National Institute of Mental Health. Attention Deficit Hyperactivity Disorder (ADHD). Website: http://www.nimh.nih.gov/health/topics/attention-deficit-hyperactivity-disorder-adhd/index.shtml.
(3) Centers for Disease Control and Prevention. ADHD: Data and Statistics. Website: http://www.cdc.gov/ncbddd/adhd/data.html.
(4) Adler, Lenard. “Scattered Minds Hope and Help for Adults with Attention Deficit Hyperactivity Disorder.” New York: Perigee Trade, 2007.
(5) 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.
(6) Faraone, S.V. and Biederman, J. Is ADHD Familial? Harvard Review of Psychiatry, January/February 2004.
(7) Zeigler, Chris A., ed. “CHADD Educators Manual on Attention Deficit Hyperactivity Disorder.” Lynchburgh: Progress Printing, 2006.