Supernus Pharmaceuticals, Inc.
) 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
Although the competition in the US ADHD market is severe, with
generic versions of
Johnson & Johnson's
) Concerta and
) 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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