October 12, 2016
Supernus Announces Positive Clinical Trial Results
Supernus Pharmaceuticals, Inc., a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, today 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 (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.
“We are very excited about these results and that SPN-812 met the objectives of the study with an encouraging and strong clinical profile,” stated Jack Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals. “We believe SPN-812 has the potential of being a well differentiated treatment for ADHD that sets itself apart from current treatment options.”