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Title: Long-Term Safety Study of Methylphenidate Patch Shows Benefits in Children With ADHD: Presented at APA

"Long-Term Safety Study of Methylphenidate Patch Shows Benefits in Children With ADHD: Presented at APA"

By Danny Kucharsky TORONTO, CANADA -- May 29, 2006 -- Long-term exposure to a daily methylphenidate patch is generally well tolerated in pediatric patients with attention deficit/hyperactivity disorder (ADHD), according to 8-month interim data presented here at the American Psychiatric Association Annual Meeting (APA). The interim results of a multicenter, long-term, open-label study, presented on May 24[^th, suggest that the methylphenidate transdermal system (MTS) formulation may be a safe alternative to oral medications in children with ADHD.

Results involve 326 children with ADHD aged 6 to 12 years who applied the patches each morning and wore them for approximately 9 hours per day. Subjects had previously participated in studies MTS (N17-021), (SPD485-102), (SPD485-201), or (SPD485-302).

The researchers evaluated the treatment's safety by the occurrence of treatment-emergent adverse events, physical exams, vital signs, laboratory tests, electrocardiograms, skin tolerance, and sleep evaluations.

To date, 7.7% of children discontinued treatment because of adverse events, while 6.1% of children discontinued due to skin irritations, most of them mild erythema that typically dissipated after patch removal, said presenting author Oscar Bukstein, MD, associate professor of psychiatry, Western Psychiatric Institute and Clinic, Pittsburgh, Pennsylvania.

During the 8-month evaluation period, there were 768 adverse events, 98% of them mild to moderate in intensity. Almost half the adverse events (47.7%) were deemed by investigators to be either possibly or probably related to the study medication.

Fifteen severe adverse events were recorded for 12 subjects. Cases of decreased appetite or weight, asthma, depression, or altered mood were considered to be possibly or probably related to the study medication.

The adverse events reported in this study are consistent with adverse events commonly reported for methylphenidate in the pediatric population, Dr. Bukstein noted.

"The patch stayed on fairly well," Dr. Bukstein said, adding that most children don't mind wearing the transdermal patch since it is worn below the belt and is usually not visible.

The study was sponsored by Shire.

[Presentation title: Interim Results From a Long-Term Safety Study of MTS. Abstract NR636]

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