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OROS(R) Methylphenidate in Adults with ADHD: New Insights
Date:5/7/2008

Final results of sub-analyses of dose-titration study and long-term,

open-label study presented today

WASHINGTON, May 7 /PRNewswire/ -- Although once considered to be a disorder only seen in children, Attention Deficit Hyperactivity Disorder (ADHD) is now known to be a condition associated with a wide range of functional impairments throughout the lifespan(1). In the US, the overall prevalence of ADHD in adults is estimated to range between 3.4% and 4.4%(2), and between 30 and 70% of children with ADHD continue to exhibit symptoms into adult years(3).

Today at the 161st Annual Meeting of the American Psychiatric Association (APA) there were new insights provided into treatment of adult ADHD with OROS(R) methylphenidate (MPH) HCl Extended-release Tablets. The findings included efficacy and safety sub-analyses from a randomized, double-blind, placebo-controlled, dose-titration trial completed in 2007 and final results from a long-term, open-label safety trial.

"What we're learning more and more is that adult ADHD, while considered the same medical condition as pediatric ADHD, often has a strikingly different patient impact due to what can be a lifetime of functional impairment related to individualized symptoms," noted Lenard Adler*, M.D., Director of the Adult ADHD Program at the NYU Langone Medical Center and Associate Professor of Psychiatry, Neurology and Child and Adolescent Psychiatry at the NYU School of Medicine. Dr. Adler* participated as an investigator in the long-term, open-label trial and was the lead investigator of the placebo-controlled dose-titration trial presented in October 2007. In that study, 226 patients with ADHD ages 18-65 were randomized to receive placebo or OROS(R) MPH (36 to 108 mg/day) for seven weeks; results showed significant improvements with OROS(R) MPH in symptom management compared to placebo.

Efficacy Findings from Short-Term, Dose-Titration Trial

In sub-analysis findings from that study presented today, OROS(R) MPH demonstrated efficacy in the study population. Specifically, OROS(R) MPH demonstrated significant efficacy in adults with ADHD across the dose range studied (36 to 108 mg/day) and consistency in symptom evaluation between clinicians (using the Adult ADHD Investigator Symptom Rating Scale [AISRS]) and patients (using the Conners' Adult ADHD Rating Scale-Self Report, Short Version [CAARS-S:S]).

"What's important about these data is that patients and clinicians in this study showed clear agreement on how each viewed the severity of the condition being treated, as well as the patient response to the medication being tested," notes Joseph M. Palumbo, M.D., Franchise Medical Leader in Psychiatry, Johnson & Johnson Pharmaceutical Research & Development, LLC (J&JPRD). "What we saw in patients' responses to treatment across the dose range studied suggest that adults with ADHD may benefit from more personalized treatment options."

Safety and Cardiovascular Data

Other findings presented today showed OROS(R) MPH to be well tolerated, with no unexpected cardiovascular effects associated with OROS(R) MPH in the study populations of the short-term dose-titration trial as well as the long-term, open-label trial. Consistent with Food and Drug Administration class labeling for all stimulant ADHD medication, which states that patients with serious cardiovascular illness should generally not be treated with stimulants, patients with a history of serious cardiovascular illness were excluded from both the short-term dose-titration study and the long-term open-label trial. Throughout both trials, heart rate and blood pressure were monitored during the titration period and the dose was reduced if certain cut-off heart rate or blood pressure values were reached. The long-term, open-label trial included an ECG every three months.

Final results from the open-label trial conducted for up to one year showed that in the study population of 550 patients, mean increases in blood pressure (BP) and heart rate (HR) observed with OROS(R) MPH were consistent with those seen in other data from the methylphenidate class. Mean systolic and diastolic blood pressure increased by 2.6 mmHg and 1.9mmHg, respectively and mean heart rate increased by 4.1 beats per minute (bpm).

Overall, cardiovascular-related adverse events occurred in 23.3% of patients and mainly consisted of BP and HR increases. There was no evidence of a treatment effect in any ECG assessment aside from an increase in HR. No deaths, heart attacks or strokes were reported and no unexpected safety findings were noted.

The safety profile of OROS(R) MPH in the long-term, open-label study's dose range of 36 mg to 108 mg per day, was consistent with that seen in shorter-term trials in adults. Adverse events with an incidence greater than 10% included decreased appetite, headache, insomnia, dry mouth, anxiety, upper respiratory tract infection, nausea, increased heart rate and irritability.

Additionally, a cardiovascular sub-analysis from the short-term dose-titration study of OROS(R) MPH versus placebo showed no clinically significant mean changes from baseline in blood pressure, heart rate or ECG parameters. The cardiovascular effects noted in this sub-analysis were consistent with those previously documented in other data from the MPH class.

Data from this sub-analysis showed similar mean changes from baseline in systolic and diastolic BP for OROS(R) MPH and placebo groups. Systolic mean change from baseline was -1.2 mmHg for OROS(R) MPH vs. -0.5 mmHg for placebo; diastolic mean change from baseline was +1.1 mmHg for OROS(R) MPH vs. +0.4 mmHg for placebo. Mean change in pulse from baseline was greater for the OROS(R) MPH group, with +3.6 beats per minute (bpm) vs. -1.6 bpm in placebo. Increased BP was the only cardiovascular adverse event reported in greater than 10% of OROS(R) MPH patients (10% for OROS(R) MPH vs. 5.2% for placebo). BP or HR increase led to down titration in 4.5% (5/110) of OROS(R) MPH patients and 0.9% (1/116) of placebo patients.

The studies were presented and sponsored by J&JPRD, which filed for U.S. approval of OROS(R) MPH for the treatment of adult ADHD last year.

The following New Research Posters on OROS(R) MPH will be presented today at APA:
NR6-019: Cardiovascular Safety Data From a Long-Term, Open-Label Study of

OROS(R) MPH in Adults with ADHD

NR6-017: A Long-Term Safety Study of OROS(R) Methlyphenidate in Adults

with ADHD

NR6-034: Cardiovascular Effects of OROS(R) MPH in a Dose-Titration Study

of Adults with ADHD

NR6-014: Treatment Response with OROS(R) MPH in a Dose-Titration Study of

Adults with ADHD

NR6-010: Clinician-Rated and Patient-Rated Symptom Improvement in a

Double-Blind, Placebo-Controlled, Dose-Titration Study of OROS(R) MPH in

Adults with ADHD

NR6-005: Efficacy of OROS(R) MPH in a Double-Blind, Placebo-Controlled,

Dose-Titration Study of Adults with ADHD: Secondary Endpoints

*Dr. Adler has been a consultant, served on advisory boards and received research grants from J&JPRD and McNeil Pediatrics(TM), Division of Ortho- McNeil-Janssen Pharmaceuticals, Inc.

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 Mental Health (NIMH), ADHD is one of the most common mental disorders in childhood. It affects an estimated four million children and adolescents in the United States.

Important Safety Information

OROS(R) MPH should not be taken by patients with: significant anxiety, tension or agitation; allergies to methylphenidate or other ingredients in OROS(R) MPH; 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 OROS(R) MPH, 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.

Johnson & Johnson Pharmaceutical Research & Development, LLC (J&JPRD) is part of Johnson & Johnson, the world's most broadly based producer of healthcare products. J&JPRD is headquartered in Raritan, NJ, and has facilities throughout Asia, Europe and the United States. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide.

McNeil Pediatrics(TM), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is committed to meeting the needs of pediatric medicine through the development of therapies specifically formulated for children. McNeil Pediatrics(TM) markets OROS(R) methylphenidate HCL for treatment of children and adolescents with ADHD in the US. McNeil Pediatrics(TM) 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.

OROS(R) is a registered trademark of ALZA Corporation.

1: Kessler RC et al, Journal of American Occupational Environmental

Medicine 2005

2: Kessler RC, Adler L, Barkley R, et al. The prevalence and correlates of

adult ADHD in the United States: Results from the National Comorbidity

Study replication. Am J Psychiatry 2006;163:716-23.insert reference

3: NIMH website, Silver LB. Attention-deficit hyperactivity disorder in

adult life. Child and Adolescent Psychiatry Clinics of North America,

2000:9:3: 411-523

Contacts:

Media Investors

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

McNeil Pediatrics Johnson & Johnson

tgeogheg@janus.jnj.com

Meredith Teague: (919) 260-7998 Lesley Fishman: (732) 524-3922

GolinHarris Johnson & Johnson

mteague@golinharris.com


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SOURCE McNeil Pediatrics(TM), Division of Ortho-McNeil-Janssen
Copyright©2008 PR Newswire.
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