Shire plc has received an approvable letter from the US Food and Drug Administration (FDA) for SPD465 (triple-bead mixed amphetamine salts MAS), an investigational oral stimulant intended to provide symptom control of ADHD in adults for up to 16 hours with one daily dose. Following receipt of this approvable letter, Shire is evaluating its options related to SPD465.

Shire submitted a New Drug Application for SPD465 on July 21, 20061. If approved, SPD465 will be a treatment option for adults with ADHD and part of Shire's overall ADHD portfolio.

Approximately 7.8 per cent of all school-age children, or about 4.4 million US children aged 4 to 17 years, have been diagnosed with ADHD at some point in their lives, according to the CDC.2 ADHD is one of the most common psychiatric disorders in children and adolescents. The disorder is also estimated to affect approximately 9.8 million adults across the U.S. based on a retrospective survey of adults aged 18 to 34, projected to the full US adult population. ADHD is a neurobiological psychiatric 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 level of development. To be properly diagnosed with ADHD, a child needs to demonstrate at least six of nine symptoms of inattention; and/or at least six of nine symptoms of hyperactivity/impulsivity; the onset of which appears before age 7 years; that some impairment from the symptoms is present in two or more settings (e.g., at school and home); that the symptoms continue for at least six months; and that there is clinically significant impairment in social, academic or occupational functioning and the symptoms cannot be better explained by another psychiatric disorder.

Although there is no "cure" for ADHD, there are accepted treatments that specifically target its symptoms. The most common standard treatments include educational approaches, psychological or behavioural modification, and medication.

SPD465, a single entity formulation of mixed amphetamine salts, was designed to provide extended release of medication with symptom control for up to 16 hours, is being studied for the treatment of ADHD in adults. The most common adverse events reported include insomnia, decreased appetite, dry mouth, headache and weight decrease.

Shire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit and hyperactivity disorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) and renal diseases.