A New Medication for Treating Adult ADHD?
Sunovion Pharmaceuticals completed its first clinical study of a drug designed to treat restlessness, impulsivity, and lack of focus in adults with ADHD.
UPDATE: In May 2020, Sunovion Pharmaceuticals Inc., halted its drug development program for dasotraline, withdrawing both New Drug Applications (NDA) for ADHD and BED (binge-eating disorder). “We believe that further clinical studies would be needed to support a regulatory approval for dasotraline in these indications,” the company said in a press release.
December 16, 2014
Researchers at Sunovion Pharmaceuticals Inc. are hopeful that they are on the road to uncovering a new therapeutic treatment option for people living with ADHD. In findings they presented at the 53rd Annual Meeting of the American College of Neuropsychopharmacology (ACNP) in December 2014, a positive result was shown when comparing the effect of the medication dasotraline on ADHD symptoms to a placebo. Dasotraline is a new dopamine and norepinephrine reuptake inhibitor (DNRI), which blocks pre-synaptic dopamine transporters to increase their levels in the brain.
The double-blind clinical trial ran for four weeks, and measured symptoms against the ADHD Rating Scale-IV, which tracks the frequency of DSM-IV criteria like hyperactivity, impulsivity, and inattentiveness. The ADHD adults who participated were randomly assigned doses of 4 mg./daily, 8 mg./daily, or a placebo. The results showed a significant improvement in symptoms for the 8-mg. dosage, and some improvement with the 4-mg. dosage. Some participants experienced side effects, including sleeplessness, anxiety, and panic attacks.
A second study is currently underway, with the goal of applying for a future New Drug Application with the Food and Drug Administration. Sunovion also intends to conduct clinical trials to evaluate the drug’s safety and usefulness in treating children with ADHD.
