Supernus (SUPN) Reports Encouraging Data From ADHD Study
Zacks Investment Research | Oct 13, 2016 02:25AM ET
Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN) announced encouraging top-line data from a phase IIb dose-ranging study (n=222) on one of its lead pipeline candidate, SPN-812, for the treatment of attention deficit hyperactivity disorder (ADHD) in children. SPN-812 is being developed as a novel non-stimulant treatment for ADHD.
The randomized, double-blind, placebo-controlled, multicenter study evaluated children aged 6 to 12 years diagnosed with ADHD. Data showed that the candidate’s 400 mg, 300 mg and 200 mg doses led to a statistically significant reduction in ADHD symptoms in comparison to placebo. On the safety front, SPN-812 was found to be well tolerated with no serious adverse events or deaths reported in the study.
Based on the results in children with ADHD and the positive phase IIa results in adult ADHD patients, Supernus plans to conduct an end-of-phase II meeting with the FDA. A positive outcome of the meeting would allow the company to move the candidate into phase III development early.
We note that SPN-812 is the company's second psychiatry candidate. The other candidate in Supernus’ psychiatry pipeline is SPN-810 (molindone hydrochloride), which is currently being evaluated in a couple of phase III studies for impulsive aggression in ADHD patients. SPN-810 enjoys Fast Track status in the U.S.
Currently, Supernus has two marketed products in its portfolio Oxtellar XR and Trokendi XR for the treatment of epilepsy.
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