, Oct. 29
/PRNewswire/ -- Data presented today at a major medical meeting include findings that demonstrate improved handwriting performance in children with Attention Deficit Hyperactivity Disorder (ADHD) when taking CONCERTA® (OROS® methylphenidate HCl Extended-Release Tablets CII) compared to placebo. This data, which was presented by McNeil Pediatrics, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is one of two sub-analyses presented today on pooled data from two randomized, double-blind, placebo-controlled studies examining CONCERTA® efficacy in patients in simulated classroom environments.
"Previous research suggests handwriting can be a challenge in children with ADHD, who may have impaired handwriting performance compared to children without ADHD,(1,2,3)" said H. Lynn Starr, M.D., director of Medical Affairs for Ortho-McNeil Janssen Scientific Affairs, L.L.C. "Based on this premise, we wanted to examine CONCERTA® treatment in this area more closely. We hope our efforts may provide insight for parents and healthcare professionals interested in this research."
In this sub-analysis (Poster 5.26), the effect of CONCERTA® on handwriting performance was evaluated in 139 patients with ADHD, ages 9 to 12, in simulated classroom settings that compared patients' handwriting skills when they were treated with CONCERTA® versus when they received placebo. Results showed patients had better handwriting performance on the days when they took CONCERTA® than on the days they took placebo.
Handwriting was assessed using the Test of Handwriting Skills-Revised (THS-R). The THS-R is a standardized assessment designed to evaluate neurosensory integration shown in print and cursive writing. In a review of previously published studies, children with ADHD scored significantly lower than children without ADHD using this measure.(1) In the CONCERTA® sub-analysis presented today, the mean THS-R standard scores showed patients scored 91.46 on the day they took CONCERTA® versus 87.03 on the day they took placebo (p<0.0001).
In a separate sub-analysis of data (Poster 5.27) from the pooled classroom studies, CONCERTA® was compared to placebo using a skill-adjusted math test that measures attention in ADHD, known as the PERMP (Permanent Product Measure of Performance).
In this analysis, all 139 patients ages 9 to 12 had a confirmed diagnosis of ADHD, and 15 patients also had a co-morbid math-based learning disability (LD). The PERMP provided patients a series of math problems during the laboratory school day. The patients' performance on problems attempted and problems correctly answered was used to evaluate the effect of CONCERTA® on attention and focus.
Results of this sub-analysis showed patients with a math LD had higher mean PERMP scores for both the number of math problems attempted (93.8 vs. 67.2, respectively; p<0.01) as well as the number of math problems answered correctly (87.8 vs. 63.0, respectively; p<0.01) following treatment with CONCERTA® compared to placebo. Similarly, patients with no math LD also had higher mean PERMP scores in both measures after treatment with CONCERTA® compared to placebo (114.2 vs. 81.6, respectively; p<0.0001; 109.9 vs. 76.8, respectively; p<0.0001).
Adverse events occurring in 10 percent or more of patients in either sub-analysis presented today were consistent with those previously reported for CONCERTA® and included decreased appetite, upper abdominal pain, headache, irritability and initial insomnia. Two patients discontinued due to adverse events. No serious adverse events or deaths were reported.
About the CONCERTA® Clinical Trials
The two posters presented today are secondary analyses taken from a data set comprised of two randomized, double-blind, placebo-controlled, crossover analog simulated-classroom trials examining the effects of CONCERTA® compared with placebo. The trials included a general population of children with ADHD and a wide range of endpoints based on standardized ADHD measurements, as well as observational input from subjects' parents, teachers and healthcare providers.
Attention Deficit Hyperactivity Disorder (ADHD) is a common and treatable medical condition characterized by inattention, hyperactivity and impulsivity that is estimated to affect about 5 million children(4) and 8 million adults(5) in the United States. While the exact cause of the condition is still unknown, scientists have focused their research on chemical messengers, or neurotransmitters, in the brain.(6) Studies suggest that 76 percent of ADHD is linked to family genetics,(6) so the condition may be more common among people who have a close relative with ADHD.(7)
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/prescribing-information.html 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.
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.
(1) Racine MB, Majnemer A, Shevell M, et al. Handwriting performance in children with attention deficit hyperactivity disorder (ADHD). J Child Neurol. 2008; 23(4):399-406.
(2) Flapper BC, Houwen S, Schoemaker MM. Fine motor skills and effects of methylphenidate in children with attention-deficit-hyperactivity disorder and developmental coordination disorder. Dev Med Child Neurol. 2006;48(3):165-169.
(3) Raggio DJ. Visuomotor perception in children with attention deficit hyperactivity disordercombined type. Percept Mot Skills. 1999 Apr; 88(2):448-50.
(4) Centers for Disease Control and Prevention. ADHD: Data and Statistics. Website: 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) 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, 13131323.
(7) Faraone, S.V. and Biederman, J. Is ADHD Familial? Harvard Review of Psychiatry, January/February 2004.
SOURCE McNeil Pediatrics(TM)