DaytranaTreatment for Attention Deficit Hyperactivity Disorder (ADHD)
Developmental Methylphenidate Patch Scheduled for FDA Advisory Committee Review
In the pivotal clinical studies, MTS was generally well tolerated and adverse events typically were mild to moderate, resolved with continued therapy and were consistent with known effects of methylphenidate. The most common adverse events reported by patients who received MTS in clinical trials were: nausea, vomiting, nasopharyngitis, weight decreased, anorexia, decreased appetite, affect lability, insomnia, tic, and nasal congestion.
Methylphenidate should not be administered to patients with: glaucoma; tics, Tourette's syndrome or a family history of Tourette's syndrome; current or recent use of Monoamine Oxidase Inhibitors (MAOIs). Chronic abuse of methylphenidate may lead to dependence and careful supervision following withdrawal from abuse is warranted. Methylphenidate should not be given to patients with a history of drug dependence or alcoholism. Methylphenidate should not be used for the prevention or treatment of severe depression or normal fatigue states. Growth should be monitored in patients treated with methylphenidate. Use with caution in patients with psychosis, history of seizures or EEG abnormalities, hypertension, a history of drug dependence or alcoholism. Rare cases of visual disturbances have been reported with methylphenidate use. Hematologic monitoring is advised during prolonged therapy.
ADHD affects approximately 7.8 percent of all school-age children, more than 4 million in the United States. ADHD is considered the most commonly diagnosed psychiatric disorder in children and adolescents. ADHD is a neurological brain disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than is typically observed in individuals at a comparable age and maturity. If untreated, ADHD can acutely affect a child's life, leading to problems with family members, friends, sports, after-school activities and academics.
Posted: October 2005
- FDA Approves Daytrana (methylphenidate transdermal system) CII for the Treatment of ADHD in Adolescents - July 7, 2010
- Daytrana Approved - Shire plc - Treatment for Attention Deficit Hyperactivity Disorder - April 6, 2006
- FDA Declares Daytrana NDA Resubmission to Be Complete Class I Response - March 10, 2006
- FDA Issues Approvable Letter for Daytrana Methylphenidate Transdermal System - December 23, 2005
- Noven to Commence Manufacture of Daytrana Methylphenidate Transdermal System - December 13, 2005
- Noven Announces Results of Daytrana Advisory Committee Meeting - December 2, 2005
- Shire and Noven Resubmitted NDA for MTS, a Candidate Treatment for Pediatric ADHD Patients - July 26, 2005