US-based biopharmaceutical company Sunovion has reported results from its Phase II/III (SEP360-221) study of dasotraline to treat moderate-to-severe binge eating disorder (BED).
Sunovion also reported that the Phase III study (SEP360-301) evaluating dasotraline in adults aged 18 to 55 years with attention deficit hyperactivity disorder (ADHD) did not meet its primary endpoint.
The Phase II/III SEP360-221 study is the first of two planned pivotal studies, evaluating its novel drug candidate dasotraline in adults ages 18 to 55, met the primary efficacy endpoint and all important secondary efficacy endpoints.
Sunovion chief medical officer and executive vice-president and Sumitomo Dainippon Pharma Group global clinical development head Antony Loebel said: “We are pleased to see such strong results in our first major study of dasotraline in patients with binge eating disorder.
“We remain confident in the potential for dasotraline to offer a new, differentiated therapeutic option for adults with BED, as well as children and adults with ADHD.”
In the SEP360-221 study, flexibly dosed dasotraline 4mg per day (p/d) to 8mg p/d demonstrated statistically significant improvement at the 12 week primary endpoint on the change from baseline in number of binge days per week compared to the placebo-treated group.
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In addition, dasotraline treatment was associated with a statistically significant improvement on all key secondary assessments: Clinical Global Impression of Severity of Illness Scale (CGI-S), the Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) and percent of subjects with four-week cessation from binge eating.
In study SEP360-301, fixed doses of dasotraline 4mg p/d and 6mg p/d did not demonstrate statistically significant improvement at the eight-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 6mg p/d group at study endpoint compared to placebo was observed.
Statistically significant improvement on the CGI-S was observed for the 6mg p/d group, but not the 4mg p/d group at study endpoint.
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 led to the lack of statistical separation at primary endpoint.
The studies reported an addition to previously reported efficacy and safety data for dasotraline, including a pivotal Phase 2/3 study in children ages 6 to 12 years with ADHD that met its primary endpoint for the 4mg p/d dose and a positive, adult ADHD Phase 2 study that met its primary endpoint for the 8mg p/d dose.
Adverse events for studies SEP360-221 and SEP360-301 were consistent with completed adult dasotraline studies and included insomnia, dry mouth, decreased appetite, anxiety, nausea and decreased weight.
The total results of study SEP360-221 and SEP360-301 are being analysed.
Following the successful completion of ongoing studies and discussions with the US Food and Drug Administration (FDA), Sunovion plans to submit a New Drug Application (NDA) to the FDA in 2017 for ADHD in children and adults.