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The most common adverse events reported in clinical studies of VYVANSE included: pediatric - loss of appetite, insomnia, abdominal pain, and irritability. The most common adverse events reported in clinical studies of ADDERALL XR included: pediatric - loss of appetite, insomnia, abdominal pain, and emotional lability; adolescent - loss of appetite, insomnia, abdominal pain, and weight loss; adult - dry mouth, loss of appetite, insomnia, headache, and weight loss.
About SPD465 (triple-bead mixed amphetamine salts):
SPD465 recently received an approvable letter from 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.
Notes to editors
SHIRE PLC
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 ADHD, human
genetic therapies (HGT), gastrointestinal (GI) and renal diseases.
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