Concerta 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.
(Logo: http://www.newscom.com/cgi-bin/prnh/20091104/CG04247LOGO-a) (Logo: http://www.newscom.com/cgi-bin/prnh/20091104/CG04247LOGO-b)
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.
Media Investor Relations Tricia Geoghegan Louise Mehrotra (Onsite US Psych) (609) 462-8764 (732) 525-6491 (609) 730-3746 lmehrot@its.jnj.com tgeogheg@its.jnj.com Lesley Fishman (732) 524-3922 lfishma@its.jnj.com
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Source: McNeil Pediatrics(TM)
CONTACT: Media, Tricia Geoghegan, Onsite US Psych,
+1-609-462-8764, or
+1-609-730-3746, tgeogheg@its.jnj.com, or Investor
Relations, Louise Mehrotra,
+1-732-525-6491, lmehrot@its.jnj.com, or Lesley
Fishman, +1-732-524-3922,
lfishma@its.jnj.com, all for
McNeil Pediatrics(TM)
Web Site: http://www.mcneilpediatrics.net/
