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October
26, 1999
LOS ANGELES,
Reuters [WN] via NewsEdge Corporation : Clinical trials show that an
experimental once-daily treatment for attention deficit disorder in
children works as well as Ritalin, which is taken in multiple daily
dosages, the companies making the new drug said Monday.
The drug, Concerta,
is an extended release version of methylphenidate, the active ingredient
in Novartis Pharmaceuticals Corp.'s Ritalin, according to
a presentation made at the American Academy of Child and Adolescent
Psychiatry in Chicago.
The study results
were submitted to the U.S. Food and Drug Administration (FDA) in July, a
spokeswoman for Mountain View, Calif.-based Alza Corp.and
Crescendo Pharmaceuticals Corp., which is based in Palo
Alto, Calif., said.
Concerta employs
Alza's "osmotic technology," which is designed to deliver
methylphenidate throughout the day.
In the double-blind
crossover study, 68 children between the ages of 6 and 12 with a clinical
diagnosis of attention deficit disorder (ADD) were given Concerta once
daily, conventional, immediate-release methylphenidate three times a day
or a placebo.
ADD or Attention
Deficit Hyperactivity Disorder, characterized by inappropriate
inattention, hyperactivity and impulsiveness, is the most common
psychiatric disorder in children, affecting about 3 to 5 percent of the
school age population, according to the American Psychiatric Association.
The children in the
study were evaluated both in the regular classroom setting and on three
consecutive Saturdays in a laboratory school, the companies said.
Based on
measurements using an inattention/overactivity scale, a significant
reduction in inattention and overactivity was shown for both Concerta and
conventional methylphenidate when compared with placebo, the companies
said.
"In this
study, the effects achieved with Concerta lasted throughout a child's
12-hour day, including the homework period and during after-school
activities," William Pelham, professor of psychology at the State
University of New York at Buffalo, said in a statement. "We believe
a once-daily dosing regimen may afford an opportunity to increase
compliance, as neither the child nor school staff needs to remember to
administer additional doses during the day."
In clinical trials,
some patients reported side effects from Concerta including headache,
stomach pain and sleeplessness.
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