Treatment with daily dasotraline 4 mg significantly improved ADHD symptoms and behaviors in children aged 6 to 12 years, according to a 6- week, placebo-controlled study.
“Approximately one-third of patients treated with stimulant medication do not respond adequately and/or experience safety or tolerability issues,” Robert L. Findling, MD, MBA, of the Kennedy Krieger Institute, Johns Hopkins University, and colleagues wrote. “Therefore, there is a clear need for additional classes of treatments for ADHD.”
The pharmacological and pharmacokinetic profile of dasotraline (Sunovion) — a potent presynaptic dopamine and norepinephrine reuptake inhibitor which is characterized by slow absorption and a long elimination half-life — makes it a promising candidate for ADHD treatment, according to Findling and colleagues.
To examine its efficacy and safety, children aged 6 to 12 years with diagnosed ADHD were randomized to 6 weeks of double-blind once-daily treatment with dasotraline (2 mg or 4 mg) or placebo. At week 6, the researchers measured participants’ change from baseline in the ADHD Rating Scale Version IV–Home Version (ADHD RS-IV HV) total score.
In 342 patients, treatment with dasotraline 4 mg per day was linked to significant improvement at study endpoint in the ADHD RS-IV HV total score compared with placebo (–17.5 vs. –11.4; P < .001). However, the 2 mg per day dose did not outperform placebo in participants (–11.8 vs. –11.4). In addition, regression analysis confirmed a significant linear dose-response relationship for dasotraline, according to the results.
The investigators also found that dasotraline 4 mg per day outperformed placebo across most secondary efficacy endpoints, including:
- the Clinical Global Impression–Severity (CGI-S) score (P = .04);
- the Conners Parent Rating Scale-Revised scale ADHD index score (P = .015); and
- hyperactivity/impulsivity and inattentiveness (P = .038 and .074).
The dasotraline 4 mg per day group had higher discontinuation rates due to adverse events (12.2%) compared with the 2 mg per day group (6.3%) and placebo (1.7%); however, there were no serious adverse events or clinically meaningful changes in blood pressure/heart rate on dasotraline. The most frequent dasotraline-related adverse events included insomnia, decreased appetite, weight loss and irritability.
“The results of the current study provide efficacy and safety data indicating that dasotraline, dosed once-per-day, is a promising therapeutic option for the treatment of ADHD, with a reduced potential for abuse, and with a long elimination half-life permitting sustained efficacy across a 24-hour dosing interval,” Findling and colleagues concluded in the Journal of Child and Adolescent Psychopharmacology. – by Savannah Demko
Disclosures: Findling reports research support from, consulting for and/or serving on a speaker’s bureau for Aevi, Akili, Alcobra, Amerex, American Academy of Child & Adolescent Psychiatry, American Psychiatric Press, Bracket, Epharma Solutions, Forest, Genentech, Guilford Press, Ironshore, Johns Hopkins University Press, KemPharm, Lundbeck, Merck, NIH, Neurim, Nuvelution, Otsuka, Patient-Centered Outcomes Research Institute, Pfizer, Physicians Postgraduate Press, Purdue, Roche, Sage, Shire, Sunovion, Supernus Pharmaceuticals, Syneurx, Teva, Tris, TouchPoint, Validus and WebMD. Please see the study for all other authors’ relevant financial disclosures.