Posted by mrporter1 on June 26, 2003, at 17:26:56
In reply to Is selegeline ever used for ADD?, posted by tanafofana on June 26, 2003, at 17:01:57
Just read this article....
June 2003 • Volume 31 • Number 6
PsychopharmacologyNo dietary restrictions
Transdermal MAO Inhibitor Patch Effective for ADHD
Elizabeth Mechcatie
Senior WriterWASHINGTON — A transdermal patch containing the selective monoamine oxidase inhibitor selegiline applied daily appeared effective and well tolerated in a pilot study of children and adolescents with attention-deficit hyperactivity disorder, Michael Reed, Pharm.D., said at the annual meeting of the American Society for Clinical Pharmacology and Therapeutics.
Selegiline is a specific monoamine oxidase (MAO) type B inhibitor, so it “is essentially devoid of the tyramine-cheese effect we think about with MAO [type A] inhibitors,” said Dr. Reed, professor of pediatrics and director of the pediatric pharmacology program at Case Western Reserve University, Cleveland.
When taken orally, selegiline has a very high first-pass effect; this is circumvented with the transdermal formulation, resulting in sustained plasma levels and 50 times more of the parent compound, and far fewer metabolites, in the body, he said. Another benefit of the transdermal formulation, manufactured by Somerset Pharmaceuticals Inc., is that it addresses a disadvantage of current treatments—the lack of privacy for children and adolescents who need to visit the school nurse for their medication.
The oral formulation, marketed as Eldepryl, is approved as an adjunct to levodopa/carbidopa for treating people with Parkinson's disease. Selegiline is metabolized into methamphetamine and desmethylselegiline, both of which are then metabolized into amphetamine.
Efficacy and tolerability of the patch were evaluated in the phase II, open-label trial in 30 children aged 6-11 years and 19 adolescents aged 12-17 years. All of the subjects met the DSM-IV criteria for combined type ADHD and were otherwise healthy. The starting dosage of transdermal selegiline for the younger group was 10 mg/day and was increased to 15 mg/day after 4 weeks if necessary; the older group started at 15 mg/day, increasing to 20 mg/day after 4 weeks if necessary in this study, which was sponsored by the National Institute of Child Health and Human Development and by Somerset Pharmaceuticals.
Significant improvements were seen in both children and adolescents in the primary rating scale used, the ADHD Rating Scale, from baseline to week 4, from weeks 4 to 8, and from baseline to week 8.
However, the dropout rate was high: After 4 weeks, 17 children and 19 adolescents remained in the trial—decreases of 23% and 0%, respectively. After 8 weeks, the dropout rate was 47% and 16%, respectively, with only 16 remaining in each group.
Still, Dr. Reed said, marked improvements were observed among the 32 who completed the trial, with no differences between groups. Secondary rating scales, such as those completed by parents and teachers, also improved significantly with treatment.
Nearly 40% of the subjects had application site reactions by week 4, a rate that dropped to 14% by week 8; all cases were mild.
In pharmacokinetic studies performed in a few of the children and adolescents, clearance of the drug appeared to be more rapid in children, which may partly explain why more children dropped out in the first 4 weeks, but this needs to be studied further, he said.
A patch formulation of methylphenidate also is currently being investigated; the manufacturer, Noven Pharmaceuticals Inc., filed for its approval for the treatment of ADHD with the Food and Drug Administration in June 2002.
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