Shire plc has announced that DAYTRANA (methylphenidate transdermal system), its Attention Deficit Hyperactivity Disorder (ADHD) patch, had significant efficacy in reducing the symptoms of ADHD in both male and female children aged 6 to 12 years, according to clinical trial results reported at the American Psychiatric Association (APA) annual meeting in San Diego.
"Few clinical studies have examined gender differences in the response to ADHD treatments. Our study documented that DAYTRANA offered a favorable safety profile and was an effective ADHD treatment in both boys and girls," said Robert Findling, M.D., lead investigator and Professor of Psychiatry at Case Western Reserve University and Director of the Division of Adolescent and Child Psychiatry at University Hospitals Case Medical Center. "The study provides a platform to open a dialogue about gender and ADHD."
Approximately 4.4 million U.S. children aged 4 to 17 years -- about 7.8 percent of all school-age children -- have been diagnosed with ADHD at some point in their lives, according to the U.S. Centers for Disease Control and Prevention (CDC). Studies estimated that 11.0 percent of boys have been diagnosed with ADHD in contrast to only 4.4 percent of girls. Experts believe that girls with ADHD are underdiagnosed and, therefore, undertreated.
Shire's DAYTRANA is the first and only patch medication approved by the U.S. Food and Drug Administration (FDA) to treat the symptoms of ADHD in children aged 6 to 12 years. DAYTRANA is available in four dosage strengths 10 mg, 15 mg, 20 mg and 30 mg all designed for once-daily use. When worn for the recommended nine hours, efficacy has been demonstrated from the first time point measured (two hours) through the 12-hour time point. Because Daytrana is a patch, physicians may recommend that patients shorten the wear time if shorter duration of effect is desired or to help manage the potential for late-day side effects.
Significant Symptom Control for Boys and Girls In this double-blind, 7-week, parallel-group study, investigators randomized 270 children to receive DAYTRANA, OROS methylphenidate or placebo. The 96 children (ITT population) in the DAYTRANA group reported a significant mean reduction of 56.5 percent in their ADHD Rating Scale-IV (ADHD-RS-IV) total scores (-24.24 14.55 points, P<.0001 vs. placebo) from the study start to end, the study's primary endpoint.
The 58 boys that received DAYTRANA averaged a significant 56 percent ADHD-RS-IV total score reduction (-24.28 15.66 points, P<.0001), while the 38 girls averaged a significant 57.4 percent reduction (-24.18 12.88 points, P<.0001).
ADHD-RS-IV assesses 18 individual symptoms of ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR ), a publication of the American Psychiatric Association.
Investigators monitored adverse events throughout the study and for 30 days after the last dose. Adverse events typically were mild to moderate in severity and were consistent with known effects of methylphenidate. No serious adverse events were reported.
The most common treatment-emergent adverse events (>10 percent) in both boys and girls in the trial were decreased appetite, headache, insomnia, nausea and vomiting. Boys in the DAYTRANA group had a higher incidence of vomiting (9 boys vs. 1 girl), tic (7 vs. 0), upper abdominal pain (6 vs. 1), irritability (7 vs. 0) and affect lability (6 vs. 0).