Noven Pharmaceuticals, Inc. confirmed that Shire plc has launched Daytrana (methylphenidate transdermal system), the first and only transdermal medication approved to treat the symptoms of Attention Deficit Hyperactivity Disorder (ADHD) in children aged six to twelve years, and that the product is now available in retail pharmacies. Shire, the market leader in ADHD, is the exclusive, global licensee of Daytrana, which was developed and is manufactured by Noven.
"As an organization, we greatly appreciate the opportunity to work with our partner Shire to assure a successful product launch," said Robert C. Strauss, Noven's President, CEO & Chairman. "It is gratifying to know that Noven's science and technologies, as well as the efforts and dedication of our employees, have contributed to the availability of the first patch therapy for ADHD."
The US Food and Drug Administration approved Daytrana on April 6, 2006. The product was developed by Noven and combines the active ingredient, methylphenidate, with Noven's patented DOT Matrix transdermal technology. This transdermal delivery system was designed to provide continuous release of medication throughout the day. The patch is designed to stay on during the normal daily activities of a child such as swimming, exercising or bathing.
Daytrana was generally well tolerated in clinical studies. As with other products containing methylphenidate (the active ingredient in Daytrana), common side effects reported with Daytrana were decreased appetite, insomnia, nausea, vomiting, weight loss, tics, and affect lability (mood swings). Abuse of methylphenidate may lead to dependence.
Parents or caregivers should tell the child's physician about any heart conditions their child or family members may have. Also parents and caregivers should tell the doctor if their child has a history of high blood pressure, problems with alcohol or drugs, depression, bipolar disorder, abnormal thoughts/behaviours, visual disturbances, or seizures. Inform the doctor immediately if the child develops symptoms that suggest heart problems, such as chest pain or fainting. Aggression, new abnormal thoughts/behaviours, mania, and growth suppression have been associated with use of drugs of this type. Methylphenidate should not be taken by children with significant agitation; glaucoma; tics, family history or diagnosis of Tourette's syndrome; or current/recent use of MAO inhibitors (a type of antidepressant). Daytrana should not be used by children allergic to methylphenidate or other ingredients in Daytrana.
Daytrana should be applied daily to clean, dry skin, which is free of any cuts or irritation. Skin irritation or allergic skin rash may occur.