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Tuesday, 10/11/2016 8:51:20 AM

Tuesday, October 11, 2016 8:51:20 AM

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Supernus Announces Positive Results from Phase IIb Clinical Trial For SPN-812 in Children with ADHD
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Supernus Announces Positive Results from Phase IIb Clinical Trial For SPN-812 in Children with ADHD
-- Study confirms efficacy and tolerability of SPN-812, a novel

non-stimulant product, in children with ADHD

-- Study meets primary endpoint with statistically significant reduction in

ADHD symptoms

-- Conference call and webcast to discuss results at 9:00 a.m. ET, October

11, 2016

ROCKVILLE, Md., Oct. 11, 2016 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN), a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, today announced positive topline results from its Phase IIb dose-ranging clinical trial of SPN-812 in children for the treatment of attention deficit hyperactivity disorder (ADHD).

The trial was successful in meeting the primary endpoint, demonstrating that SPN-812 at daily doses of 400 mg, 300 mg and 200 mg achieved a statistically significant improvement in the symptoms of ADHD from baseline to end of study as measured by the ADHD Rating Scale-IV. All SPN-812 doses tested in the trial were well tolerated. Based on these positive results in children with ADHD and the positive Phase IIa results in adults with ADHD, Supernus plans to have an end-of-Phase II meeting with the U.S. Food and Drug Administration (FDA) after which it will initiate Phase III clinical testing.

"We are very excited about these results and that SPN-812 met the objectives of the study with an encouraging and strong clinical profile, " stated Jack Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals. "We believe SPN-812 has the potential of being a well differentiated treatment for ADHD that sets itself apart from current treatment options."

Phase IIb Study Design

The study was a randomized, double-blind, placebo controlled, multicenter, dose-ranging clinical trial in children 6 to 12 years of age diagnosed with ADHD. Each treatment was administered orally once a day over five weeks, after a three week titration phase. A total of 222 patients were randomized in the study across placebo and four doses of SPN-812 (100/200/300/400mg). The primary objective of the study was to assess the effect of SPN-812 in reducing the symptoms of ADHD in children. The primary outcome measure was the change from baseline to the end of the study in the ADHD-RS-IV total score. Safety and tolerability of SPN-812 were assessed by the monitoring of adverse events, clinical laboratory tests, vital signs, ECGs, suicidality and physical examinations. Patients who completed the study were offered the opportunity to continue into an open-label phase that is currently on-going.

Topline Results

At the end of the study, SPN-812 400 mg, 300 mg and 200 mg doses were statistically significant compared to placebo in the primary endpoint. Patients receiving SPN-812 400 mg, 300 mg and 200 mg had a -19.0 point change (p=0.021), -18.6 point change (p=0.027) and a -18.4 point change (p=0.031) from baseline, respectively, in the primary endpoint vs. -10.5 for placebo.

This primary analysis using the Intent-To-Treat (ITT) population with last observation carried forward (LOCF) was confirmed with sensitivity analyses using the Per Protocol population and Mixed Model Repeated Measures (MMRM).

With respect to the effect size, patients receiving SPN-812 400 mg, 300 mg and 200 mg had a median effect size of 0.63, 0.60 and 0.55, respectively. Patients receiving SPN-812 100 mg had a -16.7 point change from baseline in the primary endpoint and a median effect size of 0.46, which did not quite reach statistical significance (p=0.089) in this relatively low number of patients.

In addition, SPN-812 400 mg, 300 mg and 200 mg met the Clinical Global Impression Severity (CGI-S) secondary endpoint with p- values of 0.014, 0.015 and 0.031, respectively, compared to placebo.

"These results exhibit a strong clinical efficacy profile with effect sizes that are typically not seen with non-stimulants. In addition, of the 160 patients who completed the trial, 87% or 139 patients chose to enter the open-label phase showing a high level of confidence in SPN-812," stated Dr. Stefan Schwabe, Executive Vice President R&D, Chief Medical Officer of Supernus Pharmaceuticals.

SPN-812 was well tolerated in the study. All four active doses were well tolerated, with adverse events almost entirely mild or moderate in severity. Two subjects experienced three adverse events that were classified as severe and related to the medication; one on 400 mg with easy tearfulness and intermittent irritability and another on 200 mg with decreased appetite. There were no serious adverse events or deaths in the study. The most frequent adverse events across all the active doses were primarily somnolence, headache, decreased appetite, fatigue, vomiting and nausea. On average, the percentage of patients discontinuing the study due to adverse events for all active doses of SPN-812 was low at 6.7%.

"We believe this side effect profile compares very well with existing treatments in the market," added Dr. Schwabe.

Product Pipeline

SPN-812 is the company's second psychiatry product in late stage development. Supernus is also developing SPN-810 (molindone hydrochloride), a novel treatment for impulsive aggression in patients with ADHD. SPN-810 is currently in clinical development with two Phase III trials in children with ADHD.

"We are excited about our psychiatry pipeline, with two late-stage novel product candidates with positive Phase II clinical results. With SPN-812 now proceeding towards Phase III clinical testing, Supernus expects to have two product candidates in Phase III testing in 2017. We believe these two product candidates represent a significant platform for future growth for Supernus in multi-billion dollar markets," added Jack Khattar.

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