Posted by djmmm on April 17, 2003, at 13:20:47
from Medscape
Selegiline Patch Effective for Children and Adolescents With ADHD
By Will Boggs, MD
WASHINGTON (Reuters Health) Apr 03 - A new patch formulation of selegiline is effective in treating attention deficit-hyperactivity disorder (ADHD) in children and adolescents, according to research presented here Wednesday at the 2003 Annual Meeting of the American Society of Clinical Pharmacology and Therapeutics (ASCPT).
Selegiline is a selective, irreversible MAO-B inhibitor that has been shown in preliminary studies to have some efficacy in ADHD, Dr. Michael Reed from Case Western Reserve University in Cleveland, Ohio said in his presentation, but the patch delivery system has not been tested before. "This system avoids the first-pass metabolism seen with oral dosing providing about 50 times more parent drug to the blood than the oral formulation," he said.
Thirty children (age 6 to 12) and 19 adolescents (age 12 to 18) were begun on daily treatment with 10 mg and 15 mg, respectively, with provision for advancement of the doses to 15 mg and 20 mg, respectively, based on clinical control of ADHD. Fourteen children and 3 adolescents dropped before the end of the study, Dr. Reed reported, mainly due to lack of ADHD control.
Preliminary pharmacokinetic data indicated significant differences in the mean half-life in children (6.8 hours) and adolescents (8.8 hours) and in the clearance of the drug (382 mL/min/kg in children and 133 mL/min/kg). "This substantial difference in the pharmacokinetics may explain the dropout we saw among the children," Dr. Reed explained. "We still need to look at the metabolite concentrations."
At all assessment intervals (weeks 0 to 4, 4 to 8, and 0 to 8), the selegiline topical system (STS) proved superior to placebo patch in ADHD Rating Scale scores, Dr. Reed said. Moreover, marked improvement was observed with STS in all 6 rating scales, including those that were investigator-based, those that were parent-based, and those that were teacher-based.
About 37% of the patients developed reactions at the application sites of the patches, Dr. Reed said, but they were all mild reactions.
"If I were to design the follow-up study," Dr. Reed added, "I'd allow higher doses and two incremental options. I'd start the children on a 15-mg patch and allow two one-step increases to 20 mg and 25 mg. For the adolescents, I'd start with 20 mg and allow increases to 25 mg and 30 mg."
poster:djmmm
thread:220079
URL: http://www.dr-bob.org/babble/20030417/msgs/220079.html