The FDA has approved a long-acting fixed-dose combination of the stimulant dexmethylphenidate and the prodrug serdexmethylphenidate (Azstarys – Corium) for once-daily treatment of attention-deficit/hyperactivity disorder (ADHD) in patients ≥6 years old. Azstarys is the first product containing serdexmethylphenidate to become available in the US.

The FDA has approved Aptensio XR (Rhodes), an extended-release formulation of methylphenidate hydrochloride, for treatment of attention-deficit/hyperactivity disorder (ADHD). The Aptensio XR capsules contain multilayer beads designed to provide both a rapid onset and a long duration of action. This formulation of methylphenidate has been available in Canada as Biphentin since 2006.

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FDA approval of lisdexamfetamine for this indication was based on two unpublished, 12-week trials, summarized in the package insert, that randomized patients with moderate-to-severe binge eating disorder to lisdexamfetamine 30 mg/day, which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.

Download complete U.S. English article

The FDA has approved a once-daily, extended-release oral suspension of methylphenidate (Quillivant XR – Pfizer) for treatment of attention-deficit/hyperactivity disorder (ADHD). It is the first liquid formulation of the drug to be marketed for once-daily use. A short-acting oral solution (Methylin, and generics) has been available since 2003.

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.

The FDA has approved an extended-release formulation of clonidine hydrochloride (Kapvay– Shionogi) for treatment of attention-deficit/hyperactivity disorder (ADHD) in children 6-17 years old. It is the second alpha₂-adrenergic agonist approved for this indication; guanfacine hydrochloride (Intuniv) was the first, but only clonidine is approved for use with stimulants.

Short-acting methylphenidate (MPH) is effective for treatment of attention-deficit/hyperactivity disorder (ADHD), but its 3-5 hour duration of action usually requires mid-day dosing in school, which children may find disruptive or stigmatizing.

The American Heart Association (AHA) recently published a statement saying that it would be reasonable to obtain an electrocardiogram (ECG) in children being evaluated for stimulant drug therapy for attention deficit hyperactivity disorder (ADHD). A subsequent news release in conjunction with the American Academy of Pediatrics provided a clarification, saying that it would be reasonable to consider obtaining an ECG in such children.

Attention-deficit/hyperactivity disorder (ADHD) is a disruptive behavior disorder that occurs in 5-7% of school-age children and has also been estimated to occur in about 4% of adults. ADHD is characterized by a persistent pattern of frequent, severe inattention and/or hyperactivity/impulsivity that starts before the age of 7, is present in 2 or more settings (such as home and school), causes significant impairment in function, and is not caused by another mental disorder. The drugs approved for treatment of ADHD by the FDA are listed in this article. Except for atomoxetine, they are all stimulants and are classified as controlled substances by the US Drug Enforcement Administration (DEA).

Atomoxetine (Strattera - Lilly), a nonstimulant drug that is not a controlled substance, was approved by the FDA in early 2003 for the treatment of attention deficit hyperactivity disorder (ADHD). At that time, The Medical Letter concluded that it was unclear whether atomoxetine was as effective as stimulants such as methylphenidate (Concerta, and others) (Medical Letter 2003; 45:11). Since then, the drug has been heavily advertised directly to the public for use in both children and adults.

With the 2004 Olympics only weeks away, performance-enhancing drugs will once again be receiving a great deal of attention. The US Anti-Doping Agency has published a list of drugs banned in Olympic sports (www.usantidoping.org) that includes, at least for some sports, all but 2 of the drugs reviewed here.