Vyvanse™ Produced a Significantly Less Abuse-Related Liking Effect

• The Drug Rating Questionnaire Subject (DRQS) was used to assess the abuse-related effects of Vyvanse at equivalent doses to d-amphetamine
• DRQS is a validated 29-point scale designed to measure the abuse potential of controlled substances

Oral study^[3]

• Design: Randomized, double-blind, placebo- and active-controlled crossover study^[3]
• Objectives^[3]:

• Evaluate the safety and tolerability of Vyvanse administered orally in adults with a history of drug abuse (N = 36)
• Assess the abuse liability of Vyvanse using a validated scale

• Results:

• Vyvanse 100 mg did not produce a statistically significant difference in liking effect versus placebo (Figure 5-1) ^[2,3]
• Oral administration of Vyvanse 150 mg produced increases in positive subjective responses that were statistically indistinguishable from the positive subjective responses produced by 40 mg of oral immediate-release d-amphetamine ^[2,3]
• Vyvanse produced a significantly lower abuse-related liking effect than d-amphetamine at an equivalent dose^[3]

• Amphetamines have a high potential for abuse. Administration of amphetamines for prolonged periods of time may lead to drug dependence

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.