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Daytrana

Generic name: methylphenidate
Treatment for: Attention Deficit Hyperactivity Disorder (ADHD)

Shire and Noven Resubmitted NDA for MTS, a Candidate Treatment for Pediatric ADHD Patients

PHILADELPHIA, July 26, 2005 -- The U.S. Food and Drug Administration (FDA) has accepted for review the amended New Drug Application (NDA) for MTS (methylphenidate transdermal system) recently resubmitted by Shire Pharmaceuticals Group plc and Noven Pharmaceuticals, Inc. MTS is a transdermal patch designed for once-daily use to treat attention deficit hyperactivity disorder (ADHD) in children aged 6 to 12 years.

The NDA amendment includes new clinical data that address the efficacy, dosing, duration of wear, and tolerability of MTS. If approved, MTS would be available in 10 milligram (mg) (12.5 cm2), 16 mg (18.75 cm2), 20 mg (25 cm2) and 27 mg (37.5 cm2) strengths. The FDA has confirmed that the amendment will receive a 6-month review.

"The children in clinical trials who received the methylphenidate transdermal system for the treatment of ADHD symptoms tolerated it well," said Robert Findling, MD, Professor of Psychiatry; Director, Division of Adolescent and Child Psychiatry, Case Western University. "If approved, this will be the first ADHD treatment available in a patch formulation, providing health care providers and parents with a useful tool to tailor individualized treatment for children with ADHD."

ADHD affects approximately 3 to 5 percent of all school-age children, or approximately 2 million U.S. children, and 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. ADHD can have a profound effect on a child's quality of life and can be serious enough to interfere beyond academics, leading to problems maintaining friendships, difficulties focusing on sports or other after-school activities, and challenges in relating well with other family members.

The NDA amendment includes data from a phase III study involving 270 patients and from a phase II study involving 79 patients. Both trials examined MTS treatment for seven weeks in children aged 6 to 12 years who had been previously diagnosed with ADHD. In these studies, use of MTS was well tolerated and the primary endpoints were achieved. The most common side effects in MTS-treated patients were decreased appetite, sleeplessness, sadness/crying, twitching, weight loss, nausea, vomiting, nasal congestion, inflammation of the nasal passages, and irritation (redness, itching) at site of application.

About MTS

The transdermal delivery of MTS allows continuous delivery of medication throughout the day, delivering the medication through the skin and into the blood stream.

The active ingredient in MTS is methylphenidate, a stimulant medication widely used in oral formulations for more than 50 years to treat ADHD symptoms in both children and adults. Methylphenidate is a central nervous system stimulant.

Each strength of MTS is a different size patch based on the dosage of methylphenidate. The patch, which is applied to the child's hip each morning before he or she leaves for school or starts the day's activities, is discreet, colorless, and water-resistant.

Source: Shire Pharmaceuticals Group plc

Posted: July 2005

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