Review of: Childress AC et al, J Child Adolesc Psychopharmacol 2017;28(5):306–313

In 2015, the FDA approved Dyanavel XR (amphetamine extended release oral suspension), which was the first long-acting liquid version of amphetamine on the market. To provide some context, Quillivant XR, a long-action liquid methylphenidate formulation, was approved in 2012 and appears to be fairly popular for kids who can’t or won’t swallow pills. Seeing a market opportunity, Tris Pharmaceuticals developed Dyanavel XR and funded a placebo-controlled trial that was successful enough to gain FDA approval. Recently, this study was published, and some readers might be curious to look at the quality of the data.

The study took place at 5 investigational sites in the US. A total of 108 boys and girls with ADHD (ages 6–12) were initially enrolled in a 5-week open-label phase in which all patients were given Dyanavel XR, starting at 2.5–5 mg and titrated up to a target dose of 10–20 mg/day. Nine of the children dropped out of this first phase, and 99 continued on to the placebo-controlled phase of the study. Participants were randomly assigned to either Dyanavel XR (51 patients, mean dose 17.3 mg) or placebo (48 patients). After 1 week on the medication, the children’s ADHD symptoms were evaluated with a teacher-rated instrument called the SKAMP (for the Swanson, Kotkin, Agler, M-Flynn, and Pelham Rating Scale).

The primary outcome variable was improvement in SKAMP scores from pre-dose to post-dose of medication. Dyanavel XR was more effective than placebo beginning 1 hour after the dose and continuing for 13 hours. The effect size was a very robust 1.8, in line with effect sizes reported in similar trials of other long-acting stimulants. In terms of side effects, patients on Dyanavel XR reported decreased appetite (26%), insomnia (13%), and affect lability (9%), with no substantial differences in blood pressure or pulse between the treatment and control group.

CCPR’s take
Not too surprisingly, Dyanavel XR is an effective stimulant treatment for ADHD. This study was not huge but was well-designed, and the results were judged to be robust enough to merit FDA approval. It’s another arrow in our ever-expanding quiver of stimulant options, and this liquid formulation will likely be just as popular as Quillivant XR. Being a brand-name option, its cost is high. For families that want cheaper liquid stimulants, go with either generic ProCentra (short-acting dextroamphetamine) or Methylin oral solution (short-acting methylphenidate).