CONCERTA: A New Treatment for ADHD

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CONCERTA A New Treatment for ADHD

• Susanne Cookson
• Product Specialist,
• Nov. 26, 2003

• Janssen-Ortho Inc.

2
New for attention deficit hyperactivity disorder
(ADHD)
3

• CONCERTA
• Once-daily dosing in the morning.1-3
• Eliminates in-school and after-school dosing.
  2,3
• Demonstrated reduction in hyperactivity,
  impulsivity, and inattention for 12 hours during
  school, family, and social activities. (Teacher
  IOWA I/O Concerta 5.98, MPH tid 6.35 plt0.05 vs
  placebo, p0.539 vs MPH tid) 1
• Improved ATTENTION as demonstrated on SKAMP
  scale.2
• Generally well tolerated, with an excellent
  safety profile.1-3
• CONCERTA methylphenidate HCI is indicated
  for the treatment of Attention Deficit Disorder
  (ADHD).
• CONCERTA is indicated as an integral part of
  a total treatment program for ADHD that may
  include other measures (psychological,
  educational, social). Effectiveness for more
  than 4 weeks has not been systematically
  evaluated in placebo controlled trials.
  Physicians electing to use CONCERTA for extended
  periods should periodically re-evaluate the
  long-term usefulness of the drug for the
  individual patient.

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Pharmacokinetics
CONCERTA provides
Mean MPH Plasma Concentrations of Concerta qd
and MPH tid 4

• An initial dose within 1 hour1,4
• An ascending delivery with 12 hour efficacy.1
• Minimizes fluctuations in peak-trough plasma
  concentrations seen with MPH tid,1,2

Comparative clinical significance has not been
established
Reference 1. Swanson J, Gupta S, Lam A et al.
Development of a new once-a-day formulation of
methylphenidate for the treatment of ADHD Proof
of concept and proof of product studies. Arch Gen
Psychiatry 2003 60 204-211. 4.CONCERTA
Product Monograph, Janssen-Ortho Inc. June, 2003.
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The CONCERTA Formulation5

• Advanced OROS delivery provides an initial dose
  within 1 hour and controlled release of
  methylphenidate over 12 hours 1-4

Release of Methylphenidate from a Concerta 18-mg
tablet 5
Reference 5. Data on file, Janssen-Ortho Inc.
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Demonstrated Improvement in Attention and
Behaviour 2,3
n 95
n 97
n 90
CONCERTA once daily (18, 36, or 54 mg) was
compared to methylphenidate three times daily
(15, 30, or 45 mg total daily dose) and placebo
in a 28 day double-blind, parallel group trial
with 282 children diagnosed with ADHD. Both
treatments showed significant improvement versus
placebo plt0.001.3
Reference 3. Wolraich ML, Greenhill LL, Pelham W
et al. Randomized, controlled trials of OROS
methylphenidate once a day in children with
attention-deficit/hyperactivity disorder.
Pediatrics 2001 108(4)883-892.
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Importance of controlling ADHD
Impulsivity/Hyperactivity
Inattention
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Improved Attention as Demonstrated on SKAMP
Scale1

• Once-daily OROS Methylphenidate that
  lasts through 12 hours1

p lt 0.001 compared to placebo n 64
CONCERTA once daily (18, 36, or 54 mg) was
compared to methylphenidate three times daily
(15, 30, or 45 mg total daily dose) and placebo
in a double-blind, randomized, 3-way crossover
study in 64 children aged 6-12 yrs diagnosed with
ADHD. Efficacy measures included SKAMP rating
scale, Combined Attention Score completed by
laboratory school teachers.1 Reference 1.
Swanson J, Gupta S, Lam A et al. Development of a
new once-a-day formulation of methylphenidate
for the treatment of ADHD Proof of concept and
proof of product studies. Arch Gen Psychiatry
2003 60 204-211.
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Improved Accuracy on Arithmetic Assignments
More Accurate

• Improved accuracy as reported by laboratory
  school teachers.2

Percentage Accuracy on Arithmetic Assignments
Less Accurate
CONCERTA once daily (18, 36, or 54 mg) was
compared to methylphenidate three times daily
(15, 30, or 45 mg total daily dose) and placebo
in a double-blind, crossover study of 68 children
aged 6-12 yrs.2
Reference 2. Pelham WE, Gangy EM,
Burrows-Maclean L. et al. Once-a-day Concerta
methylphenidate versus three-times-daily
methylphenidate in laboratory and natural
settings. Pediatrics 2001108(4)883-892.
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Parent Ratings of Efficacy

• Concerta was significantly superior to tid MPH
  and placebo on two parent rating scores.2

Adapted from Pelham et al. Other parameters were
not statistically different vs. MPH tid.
Concerta once daily (18, 36, or 54 mg) was
compared to methylphenidate three times daily
(15, 30, or 45 mg total daily dose) and placebo
in a double-blind, crossover study of 68 children
aged 6-12 years.
Other parameters were not
statistically different vs. MPH tid.
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Excellent Safety Profile

• Discontinuation rates due to adverse events were
  0.9 in 4 week controlled trials and 7.4 in
  uncontrolled trials up to 27 months. 4

Reference 4.CONCERTA Product Monograph,
Janssen-Ortho Inc. June, 2003.
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Starting a Patient on Concerta

• For patients not currently taking MPH, start with
  one 18-mg
• tablet in the morning.4
• When dosage increase is necessary, adjust the
  dose in 18-
• mg increments at approximately weekly intervals
  up to a
• maximum of 54mg a day.4
• Tablets must be swallowed whole and not be
  chewed,
• crushed or divided.4

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Switching a Patient From Other MPH Regimens
Recommended Dose Conversions.4

• 22 of the dose is contained in the overcoat
  which dissolves within 1 hour, providing an
  initial dose of methylphenidate.4

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Most Common adverse events regardless of
causality include headache, upper respiratory
tract infection and abdominal pain. CONCERTA
methylphenidate HCI should be given cautiously to
patients with a history of drug dependence or
alcoholism. Chronic abusive use can lead to
marked tolerance and psychological dependence
with varying degrees of abnormal
behaviour. CONCERTA should not be taken by
children under 6 years of age. CONCERTA should
not be used in patients with pre-existing
gastrointestinal narrowing. Although a causal
relationship has not been established,
suppression of growth h as been reported with the
long-term use of stimulants in children.
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Concerta(OROS) HOME TO HOMEWORK

• Once-daily dosing in the morning
• Eliminates in-school and after-school dosing 2,3
• Demonstrated reduction in hyperactivity,
  impulsivity, and inattention for 12 hours during
  school, family, and social activities.3
• Improved ATTENTION as demonstrated on SKAMP
  scale.2
• Generally well tolerated, with an excellent
  safety profile.1-3

Once-Daily Methylphenidate that Last Through 12
Hours