ALZA Corporation announced on 01-August-2000 that it has received approval from the U.S. Food & Drug Administration (FDA) to market Concerta™ (methylphenidate
HCl) extended-release tablets (CII) for the treatment of attention
deficit hyperactivity disorder (ADHD) in patients age six and older.
Developed on behalf of Crescendo Pharmaceuticals Corporation, Concerta™ is expected to be available by prescription before
the start of the 2000 school year.
Concerta™ is the first once-daily methylphenidate
medication for ADHD that works effectively throughout the entire day.
Some other forms of medication may require two or three doses per
day to achieve the desired improvement in symptoms.
"For patients taking Concerta™, the need for in-school
and after-school dosing will be eliminated," said Timothy E. Wilens,
M.D., Associate Professor of Psychiatry, Harvard Medical School,
Massachusetts General Hospital. "That's especially important for
kids with after-school activities and homework. Using this once-a-day
medication for ADHD can also help to eliminate the feelings of embarrassment
that children may have when taking medication in the middle of the
school day or during after-school activities."
The efficacy of Concerta™ was evaluated in three double-blind,
active- and placebo-controlled studies of 416 children from the
ages of six through 12. The product was evaluated in multiple settings
-- including community schools, laboratory schools (specialized
schools used to monitor children with ADHD for treatment evaluation
purposes), and at home.
Concerta™ qd (18, 36, or 54 mg) was compared to methylphenidate
given tid (15, 30, or 45 mg total daily dose) over 12 hours and
placebo in three double-blind trials in patients aged 6 to 12 years
old. In these three studies, teachers and parents consistently reported
a statistically significant improvement in attention and reduction
in overactivity throughout the day among children taking once-daily
Concerta™ versus placebo.
Concerta™ is available in 18 mg and 36 mg tablets.
It should be taken in the morning, with or without breakfast. Concerta™
tablets must be swallowed whole with the aid of liquid and must
not be chewed, divided, or crushed. Full prescribing information
for Concerta™ is available upon request through ALZA's
automated fax line at 800-859-5910 .