FDA Approves Vyvanse (lisdexamfetamine) for Binge Eating Disorder in Adults

Lisdexamfetamine is a prodrug of dextroamphetamine, a central nervous system (CNS) stimulant. The exact mechanism of action in binge eating disorder is unknown, but it is thought to involve increasing levels of norepinephrine and dopamine in the brain.

Vyvanse is indicated for the treatment of moderate to severe binge eating disorder (BED) in adults. It is also indicated for attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older. Limitations of use: Not recommended in pediatric patients younger than 6 years; not indicated for weight loss; safety and effectiveness for obesity not established.

For BED in adults: Starting dose 30 mg once daily in the morning. Titrate in increments of 20 mg at approximately weekly intervals to achieve target dose of 50-70 mg once daily. Maximum recommended dose is 70 mg once daily. Discontinue if binge eating does not improve. For severe renal impairment (GFR 15 to <30 mL/min/1.73 m2): maximum dose 50 mg/day. For end stage renal disease (GFR <15 mL/min/1.73 m2): maximum dose 30 mg/day. Administer orally with or without food; avoid afternoon doses due to potential insomnia. Capsules can be swallowed whole or opened and mixed with yogurt, water, or orange juice; consume immediately. Chewable tablets must be chewed thoroughly. Do not divide doses.

Trial data not available in label for BED. The label references clinical studies for ADHD but does not provide specific efficacy data for BED.

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. Vyvanse is not indicated for weight loss. Acidifying agents (e.g., ascorbic acid) decrease blood levels; alkalinizing agents (e.g., sodium bicarbonate) increase blood levels; adjust dosage accordingly.

Vyvanse is a first-line pharmacologic option for moderate to severe binge eating disorder in adults. It is also approved for ADHD. It should not be used for weight loss or obesity. Clinicians should monitor for cardiovascular effects and potential for abuse.