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.
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.