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Concerta (Methylphenidate HCl) Approved for Treatment of ADHD in Adolescents

Benefits of Treating ADHD can now Continue Through Teenage Years

TORONTO, ON -- August 12, 2005 -- Health Canada has approved Concerta® (methylphenidate HCl) Extended-release Tablets for use in adolescents (aged 13 to 18) with Attention Deficit Hyperactivity Disorder (ADHD).1 Until now Concerta® was approved for the treatment of ADHD in children aged six to 12 years.

In a clinical study of adolescents aged 13 to 18 years, Concerta® at doses up to 72 mg significantly reduced ADHD symptoms, such as difficulty paying attention to schoolwork.2

"ADHD causes impairments that can span over a child's or adolescent's life-time," says Dr. Declan Quinn, Royal University Hospital, University of Saskatchewan. "To give these children, and especially adolescents, a better chance in life and help them reach their full potential, a reliable treatment regimen including behavioural therapy and extended-release medication like Concerta is important. An effective once a day dose schedule will help with compliance and is very important for the adolescent."

When children and adolescents with ADHD go untreated or are inadequately treated, they can be at risk for developing poor academic performance and poor social skills which can lead to more significant consequences later in life, including unemployment, criminal behaviour and substance misuse.3,4

"One-dose-per-day medications such as Concerta control symptoms of ADHD, take medication out of the classroom and minimize the 'ups and downs' in behaviour associated with multiple dosing, throughout the day," comments Dr. Martin Gignac, child psychiatrist at the Philippe Pinel Institute in Montreal.

In two Concerta studies, namely one study with children where the ADHD comparator medication was given three times a day5 and the other, a placebo-controlled study with adolescents6, significantly more patients treated with once-a-day Concerta responded to treatment and achieved remission (i.e., normalization of function) compared to patients on the comparator medication or placebo. In the study for children, remission rates were 44% for those on Concerta compared to 16% for those on the three times a day comparator medication.7 This research suggests that Concerta is associated with superior symptom control compared to older ADHD treatments.

About ADHD
Approximately four to 11% of school-aged children/adolescents are affected by ADHD which totals up to an estimated half million children/adolescents in Canada alone.8 ADHD is characterized by three core symptoms - inattention, hyperactivity and impulsivity.

Inattention can include an inability to focus and pay attention or difficulty finishing tasks. The child is easily distracted. Hyperactivity can include fidgeting, talking excessively and a tendency to run around at inappropriate times or difficulty playing and engaging in leisure activities. Impulsivity can include difficulty awaiting turn and interrupting or intruding often on others.9

About Concerta®
Concerta is a once-daily extended-release formulation of methylphenidate. The efficacy of Concerta has been demonstrated in studies conducted in children and adolescents. Only a doctor can determine if medication is the right treatment for individuals with ADHD.

Concerta uses an advanced Oros extended-release delivery system to deliver a controlled rate of medication throughout the day. Because of its unique OROS® system, Concerta minimizes the ups and downs in blood levels experienced with stimulant medications taken several times a day.

Concerta should not be taken by patients with: significant anxiety, tension or agitation; allergies to methylphenidate or other ingredients in Concerta; glaucoma, Tourette's syndrome, tics or family history of Tourette's syndrome; current/recent use of monoamine oxidase inhibitors (MAOIs). Abuse of methylphenidate may lead to dependence. Concerta should not be taken by children under 6 years of age.

In clinical studies with children using Concerta, the most common side effects were headache, stomach pain, sleeplessness and decreased appetite. In clinical studies with adolescents using Concerta, the most common side effects were headache, accidental injury and sleeplessness.

Concerta® is marketed by Janssen-Ortho Inc.

REFERENCES:

1. Concerta® product monograph.
2. Ibid.
3. Barkley RA. Major life activity and health outcomes associated with attention-deficit/hyperactivity disorder. J Clin Psychiatry 2002; 63 (Suppl 12): 10-15.
4. Mannuzza S et al. Adult psychiatric status of hyperactive boys grown up. Am J. Psychiatry 1998; 155:493-498.
5. Steele M, Riccardelli R, Binder C. Effectiveness of OROS®-methylphenidate vs. usual care with immediate-release methylphenidate in ADHD children. Presented at the American Psychiatric Association annual meeting, May 1-6^th, 2004, New York City, USA.
6. Spencer T. et al. OROS® Methyphenidate Treatment for Adolescent Attention-Deficit/Hyperactivity Disorder. Presented at 50^th Anniversary Meeting of the American Academy of Child and Adolescent Psychiatry, Miami, FL, October 14-19, 2003.
7. Steele M, Riccardelli R, Binder C. Effectiveness of OROS®-methylphenidate vs. usual care with immediate-release methylphenidate in ADHD children. Presented at the American Psychiatric Association annual meeting, May 1-6^th, 2004, New York City, USA.
8. Figures based on Statistics Canada 2004 population by sex and age and prevalence rates from Einarson TR, Iskedjian M. Novel Antipsychotics for Patients with Attention-Deficit Hyperactivity Disorder: A Systematic Review. Ottawa: Canadian Coordinating Office for Health Technology Assessment; 2001. Technology report no. 17.
9. American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. Washington, D.C., American Psychiatric Association, 1995.


SOURCE: Janssen-Ortho Inc.

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