PHILADELPHIA, April 7 - The FDA has approved the first transdermal patch for treatment of attention deficit hyperactivity disorder (ADHD), Daytrana (methylphenidate transdermal system), Shire PLC announced here today.
The once-daily patch will be offered in doses of 10 mg, 15 mg, 20 mg, and 30 mg, according to an announcement by Shire PLC, which was licensed to market Daytrana by Noven Pharmaceuticals. Matthew Emmens, Shire's CEO, said the patch will be available by June or July.
The patch is designed to withstand normal daily activities of children without falling off, including swimming, exercising and bathing.
But because Daytrana is a patch, physicians can manage the duration of its effect and potential side effects by having the patient wear the patch for a shorter time period than the recommended nine hours on a given day. The company statement said that Daytrana demonstrated efficacy in two clinical trials of children, ages six to 12. In those studies, wearing a Daytrana patch for nine hours provided a duration of effect of 12 hours.
Robert Findling, M.D., director of adolescent and child psychiatry at Case Western Reserve, who was lead investigator of the Daytrana trials, said the approval marks important advance in treatment of ADHD because it offers clincians a therapeutic option that may be preferable to standard oral therapy.
The Daytrana phase II trial enrolled 79 children with ADHD. The patch was worn for nine hours, and efficacy was assessed throughout the day for 12 hours. Daytrana demonstrated statistically significant improvement over placebo on the measures tested. Behavior, which was measured using the Swanson, Kotkin, Agler, M-Flynn, and Pelham-Deportment (SKAMP-D) scale, was improved with Daytrana overall (mean score 3.2 for DAYTRANA versus 8.0 for placebo) and at all time points assessed up to and including 12 hours post-application (P<.01).
There was a significant improvement in the number of math problems completed by children randomized to Daytrana versus placebo (P<0.0001) as well as a significant improvement in the number of math problems attempted (P<0.001), based on results of the Permanent Product Measure of Performance (PERMP) scale.
The phase III naturalistic trial enrolled 270 participants. In that study children who wore the patch for nine hours had significant improvement in overall symptoms of ADHD (P<0.0001) compared with children randomized to placebo. By the study's end, mean ADHD-RS-IV scores declined 56% (24.2 points) from baseline for children treated with Daytrana versus a decline of 25% (10.3) for those treated with placebo (P<.0001).
In both studies, Daytrana was generally well tolerated. Common adverse events included decreased appetite, insomnia, nausea, vomiting, weight loss, tic, and affect lability (mood swings).