Supernus Pharmaceuticals, Inc. (SUPN) recently announced encouraging top-line results from a phase IIb study, which is evaluating its attention deficit and hyperactivity disorder (:ADHD) candidate, SPN-810, across three doses. The company plans to advance the candidate into phase III trials and will meet the US Food and Drug Administration (:FDA) to discuss the trial design and protocol for the same.
The multicenter randomized, double-blind, placebo controlled trial enrolled 121 children aged between 6 to 12 years with ADHD and characterized by impulsive aggression that is insufficiently controlled by optimal stimulant and psychosocial treatment. The study aims to identify the optimum dose of the candidate in children of different weight groups.
Reduction in impulsive aggression, measured with change in the score of the Retrospective - Modified Overt Aggression Scale (R-MOAS) and the rate of remission of aggression were the primary endpoints of the study.
The candidate demonstrated promising efficacy at low and medium doses withdoses with a reduction in the R-MOAS scores of of 62.6% and 57.9%, respectively, in score for the R-MOAS. .versus placebo. Low and medium dose of SPN-810 also showed significant reduction in rate of remission of aggression. However, we note that the high dose of SPN-810 did not exhibit efficacy with statistical significance.
Although the competition in the US ADHD market is severe, with generic versions of Johnson & Johnson's (JNJ) Concerta and Novartis’ (NVS) Ritalin available in the market, we note that currently there are no products approved for the treatment of impulsive aggression in ADHD patients.
We currently have a Neutral recommendation on Supernus. The stock carries a Zacks #3 Rank (Hold rating) in the short run.
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