Attention-deficit/hyperactivity disorder (ADHD) is a chronic neurodevelopmental disorder that has been diagnosed in up to 10% of school-age children in the US and frequently persists into adulthood. A study in a large Danish cohort found that ADHD was associated with higher mortality rates in children, adolescents, and adults, mainly due to accidents. Pharmacologic treatment of ADHD in children has been reported to decrease the risk of substance abuse in adolescents, and use of ADHD medications in adults has been associated with a reduced risk of serious traffic accidents and criminal behavior.4-6 Drugs approved by the FDA for treatment of ADHD are listed in Table 1.

The FDA has approved an extended-release oral suspension formulation of amphetamine (Adzenys ER – Neos) for treatment of attention deficit hyperactivity disorder (ADHD) in patients ≥6 years old. The same extended-release amphetamine product is available as an orally disintegrating tablet and is marketed as Adzenys XR-ODT. Another extended-release oral suspension formulation of amphetamine, Dyanavel XR, was approved earlier.

Two new extended-release amphetamine products have been approved by the FDA for once-daily treatment of attention-deficit/hyperactivity disorder (ADHD) in patients ≥6 years old: Adzenys XR-ODT (Neos Therapeutics), an orally distintegrating tablet, and Dyanavel XR (Tris Pharma), an oral suspension.

The FDA has approved racemic amphetamine sulfate (Evekeo – Arbor) for oral treatment of attention-deficit/hyperactivity disorder (ADHD) in children ≥3 years old. It was also approved for treatment of narcolepsy in patients ≥6 years old and for short-term treatment of obesity in patients ≥12 years old.

Attention-deficit/hyperactivity disorder (ADHD) is a disruptive behavior disorder that has been diagnosed in up to 10% of school-age children in the US, most often in boys, and frequently persists into adulthood. A recent study in a large Danish cohort found that ADHD was associated with increased mortality in children, adolescents, and adults, mainly due to accidents. Pharmacologic treatment of ADHD has been reported to lower the risk of serious traffic accidents and criminal behavior.

Lisdexamfetamine dimesylate (Vyvanse), a prodrug of dextroamphetamine previously approved for treatment of attention-deficit/hyperactivity disorder, has now been approved for treatment of moderate-to-severe binge eating disorder (recurrent episodes of compulsive overeating without purging) in adults.

FDA approval of lisdexamfetamine for this indication was based on two unpublished, 12-week trials, summarized in the package insert, that randomized patients with moderate-to-severe binge eating disorder to lisdexamfetamine 30 mg/day, which was titrated to 50 mg or, if needed, 70 mg, or to placebo. In both studies, patients treated with the active drug had a significantly greater reduction from baseline in binge days/week than those treated with placebo. In the first study (n=374), the placebo-subtracted difference was 1.35 binge days/week. In the second study (n=350), the difference was 1.66 binge days/week.

The recommended dosage of lisdexamfetamine for treatment of binge eating disorder is 30 mg/day, which can be titrated in 20-mg increments per week to a maximum of 70 mg/day. The cost of 30 days' treatment is about $217.1

Patients with eating disorders have an increased risk of overuse of stimulants for weight loss. The long-term effectiveness and safety of lisdexamfetamine in this population remain to be determined.

1. Approximate WAC. WAC = wholesaler acquisition cost or manufacturer’s published price to wholesalers; WAC represents a published catalogue or list price and may not represent an actual transactional price. Source: AnalySource® Monthly. March 5, 2015. Reprinted with permission by First Databank, Inc. All rights reserved. ©2015. www.fdbhealth.com/policies/drug-pricing-policy.

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Attention-deficit/hyperactivity disorder (ADHD) is a disruptive behavior disorder that occurs in about 5% of school-age children, most often in boys, and frequently persists into young adulthood.

Lisdexamfetamine dimesylate (Vyvanse - Shire), a prodrug in which d-amphetamine is covalently bonded to L-lysine, has been approved by the FDA for treatment of attention-deficit/hyperactivity disorder (ADHD) in children 6-12 years old. It was designed to have less potential than amphetamine itself for abuse, diversion or overdose toxicity. Like methylphenidate and amphetamines, lisdexamfetamine is a Schedule II controlled substance.