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New Study of Concerta(R) Showed Significant Improvement of ADHD Symptom Management in Adults Compared to Placebo
Date:10/26/2007

Interim Results From Open-Label Follow-up Include Longer-term Safety

Findings

BOSTON, Oct. 26 /PRNewswire/ -- Adults with Attention Deficit Hyperactivity Disorder (ADHD) treated with CONCERTA(R) OROS(R) methylphenidate HCl Extended-release Tablets showed significant improvements in ADHD symptom management compared to adults taking placebo, according to study results presented today at a major psychiatric medical meeting.

"Pharmacological treatment of children and adolescents with ADHD is clearly established but relatively less is known about the treatment of adults with ADHD," notes the study's medical director, Sally Berry, M.D., PhD., of Johnson & Johnson Pharmaceutical Research and Development, LLC. "We're encouraged that the CONCERTA(R) findings presented today -- in which CONCERTA(R) significantly improved ADHD symptom management in adults -- can benefit the growing body of knowledge in this important therapeutic area." The data presented today are part of a Supplemental New Drug Application (sNDA) submitted in August 2007 to the Food and Drug Administration for use of CONCERTA(R) to treat adults with ADHD. CONCERTA(R) is already approved for the treatment of ADHD in children and adolescents ages six to 17.

About the Study

In the study presented today, efficacy was measured as a change in the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score. The results showed that CONCERTA(R) achieved a significantly superior reduction in AISRS total score compared to placebo (p=0.012) (mean change was -10.6 +/-1.09 for the CONCERTA(R) group vs. -6.8 +/-1.06 for the placebo group.

In addition, CONCERTA(R) was significantly superior compared to placebo for the key secondary efficacy variables: change in Clinical Global Impression-Improvement (CGI-I) rating (p=0.008); change in Conners' Adult ADHD Rating Scale-Self Report (CAARS-S:S) total score (p=0.029) and change in percent of subjects meeting pre-defined Responder criteria (p=0.009).

In the study, 229 patients with ADHD aged 18-65 years were randomized to receive CONCERTA(R) 36-108 mg/day or placebo, for seven weeks. The final analysis set contained data from 226 patients(a). Patients in the CONCERTA(R) group received a starting dose of 36 mg/day and the dose was increased in 18 mg increments every seven days (+/-2 days) for up to five weeks until response (AISRS scores decreased by 30% and CGI-I rating of 1 "very much" or 2 "much" improved) was achieved or titration to the maximum dose of 108 mg. The dose could be reduced one time during the study for tolerability reasons. The mean final dose was 67.7 mg/day.

Adverse events were reported by 93 (84.5%) of patients in the CONCERTA(R) group compared with 74 (63.8%) in the placebo group. The most commonly reported adverse events with CONCERTA(R) included decreased appetite (25.5%), headache (25.5%), dry mouth (20%), anxiety (16.4%), nausea (12.7%), increased blood pressure (10%), insomnia (9.1%), initial insomnia (7.3%), increased heart rate (7.3%), bruxism (6.4%), irritability (6.4%) and muscle tightness (6.4%). There were no serious treatment emergent adverse events reported and 16 (14.5%) and 6 (5.2%) subjects in the CONCERTA(R) and placebo groups, respectively, discontinued due to adverse events.

Today's data presentation included interim results from a long-term, open-label safety study. A similar dose titration protocol was used as in the double-blind study during the first weeks of the study after which the dose was flexible within the range of 36 to 108 mg. Interim results show that CONCERTA(R) was well tolerated in an adult population with ADHD in a dose range from 36mg to 108 mg per day for up to six months.

About ADHD

Attention Deficit Hyperactivity Disorder (ADHD) is a common and treatable neuropsychiatric condition, which includes inattention, hyperactivity and impulsivity. According to the National Institutes of Health (NIH), ADHD is one of the most common mental disorders in childhood. It affects an estimated four million children and adolescents in the United States. Although once considered to be a disorder only seen in children, ADHD is now known to be a common neuropsychiatric disorder associated with a wide range of functional impairments throughout the lifespan, according to the Journal American Occupational Environmental Medicine (Kessler, RC et al 2005.)

About CONCERTA(R)

CONCERTA(R) is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents ages six-17. For more information about CONCERTA(R), including full U.S. prescribing information, please visit http://www.concerta.net, call 1-888-440-7903 or contact your health care provider.

Important Safety Information

CONCERTA(R) should not be taken by patients with: significant anxiety, tension or agitation; allergies to methylphenidate or other ingredients in CONCERTA(R); glaucoma; Tourette's syndrome, tics or family history of Tourette's syndrome. Abuse of methylphenidate may lead to dependence. Tell your health care professional if your child has had problems with alcohol or drugs, has had depression, abnormal thoughts or visions, bipolar disorder, seizures, high blood pressure or has had any heart problems or defects. If your child develops abnormal thinking or hallucinations, abnormal, extreme moods and/or excessive activity, or if aggressive behavior or hostility develops or worsens while taking CONCERTA(R), consult your health care professional. The most common adverse events reported in children receiving up to 54 mg were headache, upper respiratory tract infection and abdominal pain. The most common adverse events reported by adolescents receiving up to 72 mg were headache, accidental injury and insomnia.

About McNeil Pediatrics

McNeil Pediatrics Division of McNeil-PPC, Inc. is committed to meeting the needs of pediatric medicine through the development of therapies specifically formulated for children. McNeil Pediatrics markets CONCERTA(R) OROS(R) methylphenidate HCL for treatment of children and adolescents with ADHD in the US. McNeil Pediatrics is continuing to explore other new therapies to meet the special needs of children and the pediatric community. Visit http://www.mcneilpediatrics.net for more information.

CONCERTA(R) and OROS(R) are registered trademarks of ALZA Corporation. (a) Three patients not meeting study inclusion/exclusion criteria were

randomized to CONCERTA but did not receive study medication and were

not included in the analysis.

Contacts:

Media Investors

Tricia Geoghegan: (609) 462-8764 Louise Mehrotra: (732) 524-6491

McNeil Pediatrics Johnson & Johnson

tgeogheg@janus.jnj.com

Lesley Fishman: (732) 524-3922

Johnson & Johnson


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SOURCE McNeil Pediatrics
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