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.
Conference Call Details
The Company will hold a conference call and webcast
today, October 11, 2016, at 9:00 a.m. ET to discuss these topline
results. The call will be hosted by Jack Khattar, President and
Chief Executive Officer, and Greg Patrick, Vice President and Chief
Financial Officer. Presentation slides will be available via this
webcast link. A question and answer session with the Supernus
management team will follow the company’s remarks.
Please refer to the information below for
conference call dial-in information and webcast registration.
Callers should dial in approximately 10 minutes prior to the start
of the call.
Conference dial-in: (877) 288-1043
International dial-in: (970) 315-0267
Conference ID: 93788624
Conference Call Name: Supernus Pharmaceuticals
SPN-812 Phase IIb Topline Results
Webcast link: Click here
Following the live call, a replay will be available
on the company's website, www.supernus.com, under ‘Investors’.
About SPN-812
SPN-812 is a selective norepinephrine reuptake
inhibitor that Supernus is developing as a novel non-stimulant for
the treatment of ADHD. Based on data generated to date, the Company
believes SPN-812 could be more effective and have a better side
effect profile than other non-stimulant treatments for ADHD due to
its unique pharmacological and pharmacokinetic profile. The active
ingredient in SPN-812, viloxazine hydrochloride, has an extensive
safety record in Europe, where it was previously marketed for many
years as an antidepressant.
About Supernus Pharmaceuticals,
Inc.
Supernus Pharmaceuticals, Inc. is a specialty
pharmaceutical company focused on developing and commercializing
products for the treatment of central nervous system diseases. The
Company has two marketed products for epilepsy, Oxtellar XR®
(extended-release oxcarbazepine) and Trokendi XR® (extended-release
topiramate). The Company is also developing several product
candidates to address large market opportunities in psychiatry,
including SPN-810 for the treatment of Impulsive Aggression in ADHD
patients and SPN-812 for the treatment of ADHD.
Forward-Looking Statements:
This press release includes forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. These statements do not convey historical
information, but relate to predicted or potential future events
that are based upon management's current expectations. These
statements are subject to risks and uncertainties that could cause
actual results to differ materially from those expressed or implied
by such statements. In addition to the factors mentioned in this
press release, such risks and uncertainties include, but are not
limited to, the Company's ability to sustain and increase its
profitability; the Company's ability to raise sufficient capital to
fully implement its corporate strategy; the implementation of the
Company's corporate strategy; the Company's future financial
performance and projected expenditures; the Company's ability to
increase the number of prescriptions written for each of its
products; the Company's ability to increase its net revenue; the
Company's ability to enter into future collaborations with
pharmaceutical companies and academic institutions or to obtain
funding from government agencies; the Company's product research
and development activities, including the timing and progress of
the Company's clinical trials, and projected expenditures; the
Company's ability to receive, and the timing of any receipt of,
regulatory approvals to develop and commercialize the Company's
product candidates including SPN-812 and SPN-810; the Company's
ability to protect its intellectual property and operate its
business without infringing upon the intellectual property rights
of others; the Company's expectations regarding federal, state and
foreign regulatory requirements; the therapeutic benefits,
effectiveness and safety of the Company's product candidates; the
accuracy of the Company's estimates of the size and characteristics
of the markets that may be addressed by its product candidates; the
Company's ability to increase its manufacturing capabilities for
its products and product candidates; the Company's projected
markets and growth in markets; the Company's product formulations
and patient needs and potential funding sources; the Company's
staffing needs; and other risk factors set forth from time to time
in the Company's SEC filings made pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934, as amended. The Company
undertakes no obligation to update the information in this press
release to reflect events or circumstances after the date hereof or
to reflect the occurrence of anticipated or unanticipated
events.
Jack A. Khattar, President and CEO
Gregory S. Patrick, Vice President and CFO
Supernus Pharmaceuticals, Inc.
Tel: (301) 838-2591
Or
Investor Contact:
Peter Vozzo
Westwicke Partners
Office: (443) 213-0505
Mobile: (443) 377-4767
Email: peter.vozzo@westwicke.com
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