BY OUR PHARMA CORRESPONDENT
19th August, 2005: The Canadian health regulators have granted approved Concerta (methylphenidate HCl) Extended-release Tablets for use in adolescents (aged 13 to 18) with Attention Deficit Hyperactivity Disorder (ADHD). With the Health Canada's approval for extended indication, the drug can be now be continued through teenage years. 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. An effective once a day dose schedule will help with compliance and is very important for the adolescent. 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, a press release from Johnson & Johnson said.
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.
In two Concerta studies, namely one study with children where the ADHD comparator medication was given three times a day and the other, a placebo-controlled study with adolescents, 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 percent for those on Concerta compared to 16 per cent for those on the three times a day comparator medication. This research suggests that Concerta is associated with superior symptom control compared to older ADHD treatments.
Approximately four to 11 percent of school-aged children/adolescents are affected by ADHD which totals up to an estimated half million children/adolescents in Canada alone. 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.
Concerta is a once-daily extended-release formulation of methylphenidate. The efficacy of the drug 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 (hydromorphone) 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.
The drug 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 six 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, the release added.
Concerta is marketed by Janssen-Ortho Inc a brand-name pharmaceutical company headquartered in Toronto with a broad range of medications used in attention deficit hyperactivity disorder, psychiatry, neurology, pain management, women's health, infectious disease, gastroenterology and urology.
BY OUR PHARMA CORRESPONDENT