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
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Related links:
http://www.ortho-mcneil.com
CONTACT:
Media, Tricia Geoghegan of McNeil Pediatrics,
+1-609-462-8764, tgeogheg@janus.jnj.com; or Meredith Teague of
GolinHarris, +1-919-260-7998, mteague@golinharris.com; or
Investors, Louise Mehrotra, +1-732-524-6491, or Lesley Fishman,
+1-732-524-3922, both of Johnson & Johnson, all for McNeil
Pediatrics
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