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Supernus Pharma Needs Your Attention...

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Supernus Pharmaceuticals Inc. (SUPN) is all set to report results of its final phase III study for SPN-812 in patients 12-17 years old, dubbed P304, for the treatment of attention deficit hyperactivity disorder on Thursday, March 28, 2019, at approximately 8:00 a.m. ET.

SPN-812 is an investigational non-stimulant for the treatment of Attention-Deficit-Hyperactivity Disorder, or ADHD, under phase III development, which is believed to have a better side effect profile than other non-stimulant treatments for ADHD.

An estimated 6% to 9% of all school-age children and 3% to 5% of adults in the United States are reportedly affected by ADHD. About 25% of children with ADHD also exhibit persistent conduct problems, such as impulsive aggression, according to a report published in the Journal of the American Academy of Child and Adolescent Psychiatry.

The phase III program of SPN-812 includes four three-arm, placebo-controlled trials namely, P301 and P303 trials in patients 6-11 years old, and P302 and P304 trials in patients 12-17 years old.

The Company reported positive results from the P301 and P303 trials on December 6, 2018. Both the studies met the primary endpoint of improvement in the symptoms of ADHD from baseline to end of study as measured by the ADHD Rating Scale-5 with robust statistical significance.

The results from P302 - a pivotal phase III study of SPN-812 in adolescents 12 to 17 years of age for the treatment of attention deficit hyperactivity disorder - were reported on December 20, 2018. In this study too, the primary endpoint was achieved with robust statistical significance.

The trial dubbed P304, whose results are to be reported today marks the final study in the phase III program of SPN-812.

The Company expects to submit the New Drug Application for SPN-812 in the second half of 2019.

Our detailed report on Supernus Pharma, alerting our premium subscribers to this stock, was first published on June 11, 2012, when it was trading around $5, and then again on August 26, 2013, when it was trading around $7.

SUPN has traded in a range of $30.05 to $61.25 in the last 1 year. The stock closed Wednesday's trading at $34.38, up 0.50%.

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