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Research Updates
Study Reports Efficacy of Methylphenidate Transdermal System (Methylphenidate Patch) in Children with ADHD
Stimulant have been the most frequently used pharmacological treatment for ADHD and numerous studies have demonstrated their efficacy. In the past several years with the development of new drug delivery systems, mid-acting and long-acting methylphenidate (MPH) preparations have been available along with short-acting preparations. These longer acting preparations ensure adequate coverage over the school day without the need for mid-day dosing. However, a potential drawback of long-acting preparations is that their effects remain for the full time course regardless of the child's needs.

Noven Pharmaceuticals has developed a transdermal delivery system containing MPH. This system is designed to release MPH continuously on application to intact skin. This system holds promise in providing long-acting coverage for a limited duration that can be managed by the parent.

Pelham, et al. (2005) conducted a study to evaluate: the efficacy of a range of doses using the MPH transdermal system on a wide range of measures; whether possible delay in onset of effectiveness would affect children's behavior; and whether the adhesive properties of the system are sufficient. The study was conducted over 9 days in a summer program that included outdoor recreational activities and swimming. Study participants were 33 boys and three girls, aged 6 to 13 years who were recruited from those enrolled in a summer treatment program at the University of Buffalo, the Cleveland Clinic Children's Hospital, and the Medical University of South Carolina-Youth Division.

Results showed that all the tested doses of the MPH transdermal system were significantly different from placebo on measures of social behavior in recreational settings, classroom functioning, and parent ratings of evening behavior. There were diminishing gains as dosing increased and when combined with intensive behavioral treatment children were able to get nearly the same effect with low doses as they were with higher doses on some measures.

The MPH transdermal system showed efficacy on parent ratings of evening behavior (5 p.m. until bedtime). Therefore, the system produced behavioral improvement throughout 12 hours of wear.

No serious adverse events were reported. Appetite loss occurred in 61% of children across doses and difficulty sleeping occurred in 47% of the children across does. Side effects were more frequent at the higher dose levels. Application sites were alternated (left or right side) to reduce the occurrence of skin irritation or discomfort. None of the children in the study experienced a skin reaction severe enough to warrant discontinuing the patch.

The effects of application time on morning behavior were inconclusive.

The adhesion properties of the patch were found to be adequate. The patches adhered well through the recreational activities and in swimming.

The investigators indicated that the MPH transdermal system is an alternative for children who cannot swallow pills. Side effects were similar to those of orally administered MPH. Although there were few significant skin reactions to the patch, children with skin sensitivities were excluded from the study. A potential benefit of this delivery system is the ability to apply and remove the patch at different times depending on the need for symptom control.


Pelham, WE, Manos, MJ, Ezzell, CE, Tresco, KE, Gnagy, EM, Hoffman, MT, Onyango, AN, Fabiano, GA, Lopez-Williams, A, Wymbs, BT, Casserta, D, Chronis, A, Burrows-MacClean, L, Morse, G (2005). A Dose-Ranging Study of a Methlyphenidate Transdermal System in Children with ADHD. Journal of the American Academy of Child and Adolescent Psychiatry, 44 (6), 522-529.

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myADHD.com news is an e-publication of Health Link Systems, Inc. This publication is sponsored by myADHD.com, A.D.D. WareHouse, and the National Association for Continuing Education. Information presented here is not intended to replace the advice of a physician or other health care professional. Placement of an advertisement in this e-newsletter does not represent an endorsement of any advertised products or services or the validity of any claims advertised. Copyright 2005 by Health Link Systems, Inc. For comments or information, please send an email to: info@myadhd.com, subject line: myADHD.com News.

 


 


 

 

 

 

 

 

 

 

 

 

 

 

 
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