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About SPD465 (triple-bead mixed amphetamine salts):

SPD465 is currently under review with the U.S. Food and Drug Administration (FDA) for the treatment of ADHD in adults. SPD465, a single entity, mixed amphetamine salt formulation was studied to determine if it provides symptom control for up to 16 hours in adults with ADHD. The most commonly reported treatment-emergent adverse events were decreased appetite, insomnia, dry mouth, headache, upper abdominal pain and anorexia.

About SPD503 (guanfacine HCl extended release):

SPD503 is currently under review with FDA for the treatment of ADHD in children aged 6 to 17 years. SPD503 is a once-daily formulation of the selective alpha-2A-adrenoceptor agonist guanfacine and was studied to determine if it provided control of ADHD symptoms throughout the day in children aged 6 to 17 years. The most commonly reported treatment-emergent adverse events were headache, somnolence, fatigue, upper abdominal pain and sedation.

About ADHD

Approximately 7.8 percent of all school-age children, or about 4.4 million U.S. children aged 4 to 17 years, have been diagnosed with ADHD at some point in their lives, according to the CDC. 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 U.S. 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 wh
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