Vyvanse™ Provided Significant Efficacy Throughout the Day, Even at 6pm

• Conners’ Parent Rating Scale (CPRS) was used to assess the duration of therapeutic response in 285 patients by separately analyzing the assessments performed per protocol in the morning (approximately 10am), afternoon (approximately 2pm), and evening (approximately 6pm)^[5] (Figure 4-1)

• Significant improvements (P < .0001 vs placebo) in patient behavior were maintained throughout the day based on parent ratings (CPRS) in the morning (~ 10am), afternoon (~ 2pm), and early evening (~ 6pm)^[1]
• Vyvanse provided significant efficacy throughout the day, even at 6pm^[1]
• The most common adverse events (AEs) with Vyvanse in this study were decreased appetite, insomnia, upper abdominal pain, and irritability^[1]

Vyvanse should not be taken by patients who have advanced arteriosclerosis; symptomatic cardiovascular disease; moderate to severe hypertension; hyperthyroidism; known hypersensitivity or idiosyncrasy to sympathomimetic amines; agitated states; glaucoma; a history of drug abuse; or during or within 14 days after treatment with monoamine oxidase inhibitors (MAOIs).

Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Sudden deaths, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses in ADHD. Physicians should take a careful patient history, including family history, and physical exam, to assess the presence of cardiac disease. Patients who report symptoms of cardiac disease such as exertional chest pain and unexplained syncope should be promptly evaluated. Use with caution in patients whose underlying medical condition might be affected by increases in blood pressure or heart rate.

New psychosis, mania, aggression, growth suppression, and visual disturbances have been associated with the use of stimulants. Use with caution in patients with a history of psychosis, seizures or EEG abnormalities, bipolar disorder, or depression. Growth monitoring is advised during prolonged treatment.

Amphetamines have a high potential for abuse. Administration of amphetamines for prolonged periods of time may lead to drug dependence. Particular attention should be paid to the possibility of subjects obtaining amphetamines for non-therapeutic uses or distribution to others and the drugs should be prescribed or dispensed sparingly. Misuse of amphetamine may cause sudden death and serious cardiovascular adverse events.

The most common adverse events reported in clinical studies of Vyvanse were loss of appetite, insomnia, abdominal pain, and irritability.