Phase III study (SEP360-301) evaluating dasotraline in adults with attention deficit hyperactivity disorder fails to meet primary endpoint- Sunovion

Sunovion announced that the Phase III study (SEP360-301) evaluating dasotraline in adults ages 18 to 55 years with attention deficit hyperactivity disorder (ADHD) did not meet its primary endpoint. In study SEP360-301, fixed doses of dasotraline 4 mg/day and 6 mg/day did not demonstrate statistically significant improvement at the 8 week primary endpoint on the ADHD Rating Scale (RS) IV (with adult prompts) total score compared to the placebo-treated group. A trend toward greater improvement for the 6 mg/day group at study endpoint compared to placebo was observed (p=0.074). Statistically significant improvement on the CGI-S was observed for the 6 mg/day group (but not the 4 mg/day group) at study endpoint (p=0.011).

While the overall improvement associated with the dasotraline treatment groups was consistent with prior studies, a relatively large improvement was seen in the placebo group on the ADHD RS-IV, which may have contributed to the observed lack of statistical separation at primary endpoint.

The studies reported add to previously reported efficacy and safety data for dasotraline including a pivotal Phase II/III study in children ages 6 to 12 years with ADHD that met its primary endpoint for the 4 mg/day dose and a positive, pivotal adult ADHD Phase II study that met its primary endpoint for the 8 mg/day dose. Adverse events for study SEP360-301 were consistent with completed adult dasotraline studies and included insomnia, dry mouth, decreased appetite, anxiety, nausea and decreased weight. Full results are being analyzed and will be presented at upcoming scientific meetings.