FDA Approves Vyvanse (lisdexamfetamine) for Binge Eating Disorder

Lisdexamfetamine is a prodrug of dextroamphetamine, a central nervous system (CNS) stimulant. The exact mechanism of action in ADHD and BED is not fully understood, but it is thought to involve the increase of norepinephrine and dopamine in the synaptic cleft.

Vyvanse is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older, and for moderate to severe binge eating disorder (BED) in adults. It is not recommended in pediatric patients younger than 6 years due to higher plasma exposure and increased adverse reactions. Vyvanse is not indicated for weight loss.

For ADHD: Starting dose 30 mg once daily in the morning; may be adjusted by 10 mg or 20 mg weekly up to 70 mg/day. For BED: Starting dose 30 mg once daily; titrate by 20 mg weekly to target 50-70 mg/day; maximum 70 mg/day. Discontinue if no improvement. In severe renal impairment (GFR 15-<30 mL/min/1.73 m2), maximum 50 mg/day; in ESRD (GFR <15 mL/min/1.73 m2), maximum 30 mg/day. Administer orally in the morning with or without food. Capsules may be swallowed whole or opened and mixed with yogurt, water, or orange juice. Chewable tablets must be chewed thoroughly.

For ADHD in pediatric patients ages 6-12: A double-blind, randomized, placebo-controlled study (Study 1) enrolled 290 patients meeting DSM-IV criteria for ADHD. Patients received VYVANSE 30 mg, 50 mg, or 70 mg or placebo once daily for 4 weeks. All patients started on 30 mg for the first week. Trial data for BED: Not reported in label.

Prior to treatment, assess for cardiac disease (history, family history of sudden death or ventricular arrhythmia, physical exam). Evaluate for motor or verbal tics or Tourette's syndrome. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. Avoid afternoon doses due to potential insomnia. Acidifying agents (e.g., ascorbic acid) decrease amphetamine blood levels; alkalinizing agents (e.g., sodium bicarbonate) increase levels; adjust dosage accordingly.

Vyvanse is a first-line pharmacologic option for ADHD in adults and children 6 years and older, and for moderate to severe BED in adults. It is not recommended for weight loss or obesity. For BED, treatment should be discontinued if no improvement is observed.