Supernus announces results from Phase IIb clinical trial for SPN-812
Supernus Pharmaceuticals announced positive topline results from its Phase IIb dose-ranging clinical trial of SPN-812 in children for the treatment of attention deficit hyperactivity disorder, or ADHD. The trial was successful in meeting the primary endpoint, demonstrating that SPN-812 at daily doses of 400 mg, 300 mg and 200 mg achieved a statistically significant improvement in the symptoms of ADHD from baseline to end of study as measured by the ADHD Rating Scale-IV. All SPN-812 doses tested in the trial were well tolerated. Based on these positive results in children with ADHD and the positive Phase IIa results in adults with ADHD, Supernus plans to have an end-of-Phase II meeting with the U.S. Food and Drug Administration (FDA) after which it will initiate Phase III clinical testing.