Supernus Pharmaceuticals' Phase IIb clinical trial involving SPN-812 to determine dosing ranges has turned in positive topline results for the treatment of attention deficit hyperactivity disorder (ADHD) in children.
“We are very excited about these results and that SPN-812 met the objectives of the study with an encouraging and strong clinical profile,” Supernus President and CEO Jack Khattar said. “We believe SPN-812 has the potential of being a well differentiated treatment for ADHD that sets itself apart from current treatment options.”
The Phase IIb study was able to meet its primary objective by proving that 400 mg, 300 mg and 200 mg of SPN-812 in daily doses caused a noteworthy statistical improvement for ADHD symptoms compared to the end of study baseline that was measured by the ADHD Rating Scale-IV. All three doses administered during the trial were tolerated by patients.
Supernus has plans to hold an end-of-Phase II meeting with the U.S. Food and Drug Administration and then begin a Phase III trial.