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news.Shire Pharmaceuticals and Noven Pharmaceuticals have resubmitted to the FDA a new drug application for MTS, a drug to treat attention deficit hyperactivity disorder in children aged six to 12. MTS is delivered through the patient's skin via a patch.
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The NDA amendment includes new clinical data that address the efficacy, dosing, duration of wear, and tolerability of MTS. The FDA has confirmed that the amendment will receive a six-month review.
“The children in clinical trials who received the methylphenidate transdermal system (MTS) for the treatment of ADHD symptoms tolerated it well,” said Dr Robert Findling, professor of psychiatry at 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 3-5% of all school-age children, or approximately two million US 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.
The 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 six to 12 years who had been previously diagnosed with ADHD.