Supernus expects to enroll 50 subjects in the study at 5 sites across the US. Supernus Pharma claimed that SPN812 is one of three compounds being developed by the company to treat patients with ADHD.
SPN812 study’s primary objective is to measure safety and tolerability, with a secondary measure of efficacy in reducing symptoms of ADHD.
Earlier, Supernus Pharma has reported positive results from its Phase IIa proof-of-concept study of SPN810 for the treatment of children with ADHD who exhibit persistent serious conduct problems.
Reportedly, the trial met the primary endpoints of safety and tolerability, which demonstrated reduction versus baseline in conduct problems across all doses in children 6 to 12 years of age diagnosed with ADHD.
Jack Khattar, president and CEO of Supernus Pharma, said: “We are excited to advance our second ADHD portfolio product into Phase II. The mechanism of action of SPN812 appears to be promising as a new treatment of ADHD and we believe it represents an alternative to existing ADHD regimens in the US.”