The FDA in its complete response letter issued to the company conveyed that the new drug application (NDA) for dasotraline could not be approved in its current form.
The regulator indicated that additional clinical data are required to further evaluate the dasotraline’s efficacy and tolerability for treating ADHD.
Sunovion executive vice president and chief medical officer Antony Loebel said: “While we are disappointed with the FDA’s decision, we remain confident in the future of dasotraline.
“We plan to discuss next steps for the dasotraline ADHD program with the FDA as soon as possible.”
Sunovion had submitted the NDA for dasotraline to the FDA in September 2017. The NDA was based on data collected from the clinical program for the drug in ADHD, which included four placebo-controlled safety and efficacy trials, and two long-term studies, that evaluated the safety of the drug in patients with ADHD for up to one year.
About 2,500 children and adults having ADHD took part in the dasotraline clinical program.
Dasotraline is a dual dopamine and norepinephrine reuptake inhibitor (DNRI). According to Sunovion, the drug has an extended half-life in the range of 47-77 hours which supports the potential for stable plasma concentrations yielding a continuous treatment effect throughout the 24-hour dosing interval.
The drug is also being studied as potential treatment of moderate to severe binge eating disorder (BED) in adults.
Sunovion said that data gathered from two positive pivotal studies will be used for submitting the marketing application for dasotraline as a treatment for BED by 31 March 2019.
In late July, the company announced that the phase 3 SEP360-321 trial assessing the efficacy and safety of dasotraline in adults with moderate to severe BED met its primary endpoint. The drug delivered a statistically significant reduction in number of binge days per week from baseline to Week 12 in the patient arm treated with dasotraline 6mg/day compared to the placebo-treated group.