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Title: Methylphenidate (Concerta) Patch May Have Advantages in Treating ADHD: Presented at AACAP

"Methylphenidate (Concerta) Patch May Have Advantages in Treating ADHD: Presented at AACAP"

By Paula Moyer TORONTO, CANADA -- November 11, 2005 -- An investigational transdermal method for delivering methylphenidate (MethyPatch) may have advantages compared to an oral formulation for children with attention deficit hyperactivity disorder (ADHD), according to data presented here at the joint annual meeting of the American and Canadian Academies of Child and Adolescent Psychiatry (AACAP/CACAP). "Subjects treated with the transdermal system displayed statistically significant improvements in all efficacy measures used in this study, compared with placebo-treated subjects," said principal investigator Robert L. Findling, MD. "The transdermal system was effective at reducing the symptoms of ADHD as assessed by clinicians, teachers, and parents," said Dr. Findling, who is Professor of Psychiatry and Pediatrics, Case Western Reserve University, and Director, Child & Adolescent Psychiatry, University Hospitals of Cleveland Cleveland, Ohio, United States. In this randomized, double-blind, placebo controlled study, Dr. Findling and his co-investigators recruited 282 patients who were treated with the transdermal system, extended-release oral methylphenidate (Concerta), or placebo. Dummy patches and pills were used in the appropriate treatment arms. The children were 6 to 12 years old (average 8.8 years); 66.3% were boys. After randomization, the subjects underwent a 5-week dose optimization period in which drug doses were titrated. The patch comes in four sizes, associated with four doses: 1.1 mg/hour, 1.78 mg/hour, 2.21 mg/hour, and 2.97 mg/hour. The oral formulation came in four doses, also: 18 mg, 27 mg, 36 mg, and 54 mg. Response to treatment was defined by at least a 25% reduction in ADHD symptoms as measured by the ADHD Rating Scale-IV (ADHD RS-IV). Patients were also evaluated with the Clinical Global Impressions-Severity (CGI-S) the CGI-Improvement (CGI-I), and the Parent Global Assessment (PGA). During his presentation on October 20[^th, Dr. Findling stressed that the purpose of the study was to test the efficacy of the transdermal patch and not to compare it to the once-daily oral formulation. Subjects who responded to treatment continued on the same treatment in a 2-week, double-blind, dose-maintenance period.

A total of 169 completed the treatment period. The intent-to-treat population consisted of 270 patients, 96 in the transdermal arm, 89 in the oral arm, and 85 in the placebo arm.

Average ADHD RS-IV scores changed significantly in both treatment arms in comparison to placebo (P < .001). Those scores decreased an average of 24.2 points in the transdermal arm, 22.0 points in the oral arm, and 9.9 points in the placebo arm.

At the end of the study, 72% of the subjects in the transdermal arm were considered to have an improvement in the CGI-I as did 68% of the oral arm and 25% of the placebo arm (P < .0001 for both transdermal and oral compared to placebo).

The PGA improvements were virtually identical to those of the CGI-I scores in each arm (P < .0001 for both treatment arms in comparison to placebo).

Rates of adverse events were 75.5% in the transdermal arm, 69.2% in the oral treatment arm, and 57.6% in placebo subjects.

Adverse events primarily consisted of typical reactions to stimulant medications used to treat ADHD (loss of appetite, insomnia, nausea and vomiting, and decreased weight). Four serious events occurred: one child in the transdermal group developed aggression; one in the oral group developed syncope; and two placebo patients developed elevated hepatic enzymes.

No life-threatening events occurred, Dr. Findling said.

MethyPatch is manufactured by Shire and Noven, the former of which funded the study. McNeill Consumer & Specialty Pharmaceuticals markets Concerta in a partnership with Alza, which developed the once-daily formulation.

The application for approval by the United States Food and Drug Administration is scheduled to be reviewed in December, 2005.

[Presentation title: Efficacy of Transdermal Methylphenidate with Reference to Concerta in ADHD. Abstract B9]

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