Sunovion Pharmaceuticals Inc. (Sunovion) announced that results of a pivotal Phase 2/3 study (SEP360-202) evaluating novel drug candidate dasotraline in children ages 6 to 12 years with attention deficit hyperactivity disorder (ADHD) showed statistically significant improvement in the 4mg/day dose arm compared to placebo. The 2mg/day dose arm did not demonstrate a statistically significant difference from placebo. Sunovion announced top-line results from this study on September 20, 2016.
The full study results will be presented today at the 2017 American Professional Society of ADHD and Related Disorders (APSARD) Annual Meeting, being held January 13-15 in Washington, D.C.
Pending successful completion of ongoing studies and discussions with the U.S. Food and Drug Administration (FDA), Sunovion intends to submit a New Drug Application (NDA) to the FDA in 2017 for ADHD in children and adults.
“Sunovion is dedicated to advancing the treatment of serious neuropsychiatric conditions, such as ADHD,” said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer at Sunovion, Head of Global Clinical Development for Sumitomo Dainippon Pharma Group. “These study results are encouraging and support the efficacy and safety of dasotraline for the treatment of ADHD.”
Results from SEP360-202 pivotal study
Children taking dasotraline 4mg/day experienced a statistically significant improvement in ADHD symptoms compared to placebo, as measured by the ADHD Rating Scale IV: Home Version (ADHD RS-IV HV) total score (least squares [LS] mean change from Baseline at Week 6: -17.53 [95% CI:-20.12, -14.95] vs -11.36 [-13.89, -8.83], respectively; effect size (ES)=0.48, p<0.001).1 This statistically significant and clinically relevant improvement over placebo was maintained each week through Week 6. Improvements in Clinical Global Impression-Severity of Illness Scale (CGI-S) scores were also statistically significant in the 4 mg/day dose arm compared to placebo. The 2 mg/day dose arm did not demonstrate a statistically significant difference from placebo in the ADHD RS-IV total score and did not statistically separate from placebo in the CGI-S scores.
Both dasotraline 4mg and 2mg arms were generally well tolerated with an adverse event (AE) profile consistent with completed adult dasotraline studies.1 The most common treatment-emergent adverse events (TEAE) (reported in 5 percent or more of patients and greater than placebo) included insomnia, decreased appetite and weight decreased.