FW: 12-hour ADHD drug as effective as thrice daily doses

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From: [sMTP:C379@...]

Sent: Wednesday, June 13, 2001 1:57 AM

Subject: 12-hour ADHD drug as effective as thrice daily doses

FOR RELEASE: 4 JUNE 2001 AT 17:00 ET US

University at Buffalo

http://www.buffalo.edu/

12-hour ADHD drug as effective as thrice daily doses

BUFFALO, N.Y. -- A new 12-hour formulation of the most

commonly prescribed drug for attention-deficit/hyperactivity

disorder, or ADHD, has proved to be as effective as the

standard three-times-a-day dosing regimen, a clinical trial

conducted by University at Buffalo researchers has shown.

The extended-release formulation of methyphenidate avoids

the need for children to take medication during school or

after-school activities.

The trial of Concerta was headed by E. Pelham, Ph.D.,

professor of psychology, pediatrics, and psychiatry at UB and

one of the world's leading authorities on attention deficit

disorder. Results appear in the electronic pages of the June

issue of Pediatrics.

Researchers have been working for some time to develop an

effective and safe extended-release form of methyphenidate

that will last from early morning into the early evening.

" Kids have a terrible problem taking pills at school, " Pelham said.

" There are few school nurses anymore, which means the children

have to receive their medicine from the teacher or from someone

in the school office. Kids have to remember to do that. The problems

get worse as they get older, because teens don't want their

friends to see them taking medication. "

The trial was conducted with 68 children between the ages of

6 and 12 who already were taking a version of methylphenidate

for ADHD. The double-blind design involved three dosing

regimens: immediate-release methylphenidate given three times

a day; extended-release methylphenidate given in the morning, and

placebo. All children took each regimen for a week.

Teachers and parents rated the children's behavior and

ability to attain daily goals during the week. In addition,

children spent 12 hours on Saturdays in a classroom laboratory

setting to allow researchers to evaluate the effects of each

medication over time. Trained investigators monitored behavior

during classroom work, games and recess.

Results showed that children performed significantly better

on both the three times a day and the extended-release

medications in all settings than when receiving the placebo.

The extended-release formulation maintained its effectiveness

even after 12 hours in both the laboratory and home settings,

findings indicated. Ratings were similar for both active formulations.

Parents, teachers and children in the study also took part

in a concurrent regimen of behavior modification. Combining

behavioral modification with medication is the best way to

treat ADHD, Pelham noted.

Assessing the clinical trial itself, Pelham said: " Because it

is given only once per day, Concerta should improve compliance

with ADHD children's medication regimens and afford smoother

treatment effects throughout the day. "

Pelham acknowledged that some ADHD children do not

need medication in the evening, and that some parents

prefer not to use medication for their ADHD children.

" For those who do, however, Concerta would appear to

be a good choice of stimulant medications as part of a

total treatment package for ADHD, " he said.

###

Also participating in the trial were T. Hoffman, M.D.,

and M. Lock, M.D., of the Department of Pediatrics,

UB School of Medicine and Biomedical Sciences; Gene D. Morse,

Pharm.D., and Karl Fiebelkorn, R.Ph., of the Department of

Pharmacy Practice, UB School of Pharmacy and Pharmaceutical

Sciences; Burrows-Maclean, Ph.D., and Gnagy of the

Center for Children and Families in UB's College of Arts and Sciences.

UB psychology graduate students Andy , A.

Fabiano, M. ey, M. Chronic, L.

Forehand, Celeste A. Aguyenm, K. Coles, J. Panahon,

Randi L. Steiner, L. Meichenbaum and Adia N.

Onyango also took part.

The trial was sponsored by a grant from Alza Corp., manufacturer

of Concerta. Pelham's research is supported by grants from the

National Institute on Alcohol Abuse and Alcoholism and the National

Institute of Mental Health.

http://www.eurekalert.org/releases/ub-had053101.html