Positive results from Supernus Pharmaceuticals' SPN 810 Phase IIa trial for ADHD

Jan 27 2010

Supernus Pharmaceuticals Inc., today announced that its Phase IIa U.S. clinical trial for SPN 810 in children with ADHD and persistent serious conduct problems met the primary endpoints of safety and tolerability, as well as showed statistically significant reduction versus baseline in conduct problems across all doses. The trial was initiated in 2009 and was a proof-of-concept, open-label study in children 6 to 12 years of age, assigned to one of four doses over a six-week treatment period, after 2-5 weeks' titration.

“The product showed reductions of 32% at the lowest tested dose and 55% at the highest tested dose in persistent serious conduct problems with aggression as a key feature”

“The product showed reductions of 32% at the lowest tested dose and 55% at the highest tested dose in persistent serious conduct problems with aggression as a key feature,” said Dr. Robert Findling, MD, the lead investigator for the study. “This is a clinically meaningful and very encouraging set of data. Serious conduct problems are quite prevalent in children with ADHD and there are currently no approved treatments for this unmet medical need.” Results were measured by the conduct problem subscale of the Nisonger Child Behavioral Rating Form (NCBRF).

“We are very excited about these positive results and the future development of SPN 810. The product is one of several programs in our emerging ADHD portfolio,” said Jack Khattar, Supernus President and CEO.

Source Supernus Pharmaceuticals, Inc.