Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN), a pharmaceutical
company focused on developing and commercializing products for the
treatment of central nervous system diseases, today announced
positive topline results from a pivotal Phase III study of SPN-812
in adolescents (P302) for the treatment of attention deficit
hyperactivity disorder (ADHD).
At daily doses of 200 mg and 400 mg, the trial met the primary
endpoint with robust statistical significance in improvement in the
symptoms of ADHD from baseline to end of study as measured by the
ADHD Rating Scale-5. Both active doses were well tolerated.
The Company expects to announce topline data from the final
Phase III trial of SPN-812, study P304 in adolescents, by the end
of the first quarter of 2019. The Company expects to submit a New
Drug Application for SPN-812 in the second half of 2019, and to
launch it, pending U.S. Food and Drug Administration approval, in
the second half of 2020.
“These data further reinforce the effectiveness of SPN-812 in
patients with ADHD, showing a clinically meaningful reduction in
the symptoms of ADHD, with a favorable safety and tolerability
profile,” stated Jack Khattar, President and Chief Executive
Officer of Supernus Pharmaceuticals. “We now have positive data
proving the efficacy and safety of SPN-812 in all ADHD patient
populations; positive Phase III data in children 6-11 years old and
adolescents 12-17 years old, and positive Phase IIa data in
adults.”
About the P302 Study
The study is a randomized, double-blind, placebo controlled,
multicenter, parallel group clinical trial in adolescents 12 to 17
years of age diagnosed with ADHD. Each treatment was administered
orally once a day over six weeks, including the titration phase of
the 400 mg dose group.
A total of 310 patients were randomized across placebo and two
doses of SPN-812 (200mg/400mg). The primary objective was to assess
the effect of SPN-812 in reducing the symptoms of ADHD in
adolescents 12-17 years old. The primary outcome measure was the
change from baseline to the end of the study in the ADHD-RS-5 total
score. Safety and tolerability of SPN-812 were assessed by the
monitoring of adverse events (AEs), 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
P302 Study
At the end of the study, SPN-812 200 mg and 400 mg doses reached
statistical significance compared to placebo in the primary
endpoint. Patients receiving SPN-812 200 mg and 400 mg had a -16.0
point change (p=0.0232) and a -16.5 point change (p=0.0091) from
baseline, respectively, in the primary endpoint vs. -11.4 for
placebo at week 6.
This primary result, based on Mixed Model Repeated Measures
(MMRM) analysis in the Intent-To-Treat (ITT) population, was
confirmed by sensitivity analyses using Analysis of Covariance
(ANCOVA) (200 mg, p=0.0163; 400 mg, p=0.0055). With respect to the
effect size, patients receiving 200 mg and 400 mg had an effect
size of 0.47 and 0.50, respectively, within the range of 0.46 to
0.63 observed in the first two Phase III studies and the Phase IIb
study.
The study demonstrated fast onset of action, reaching
statistical significance for the 400 mg dose as early as week 1
with a p-value of 0.0085, and maintaining statistical significance
on a weekly basis through the end of the trial at week 6. Onset of
action for the 200 mg dose showed clear differences compared to
placebo starting by week 1, reaching statistical significance at
week 3, which was sustained through the rest of the trial.
Similar to the P301 and P303 studies, at the end of the P302
study, SPN-812 200 mg and 400 mg reached statistical significance
compared to placebo on the hyperactivity/impulsivity and
inattention subscales of the ADHD-RS-5 scale with p-values ranging
from 0.0005 to 0.0424.
In addition, SPN-812 200 mg and 400 mg met the Clinical Global
Impression-Improvement secondary endpoint with p-values of 0.0042
and 0.0003, respectively, compared to placebo.
Safety and tolerability
Overall, the trial exhibited favorable tolerability and safety
profiles with low incidence of AEs across all doses. AEs were mild
leading to low discontinuation rates due to AEs of 1.9% to 4.1%.
Treatment related AEs that reported at more than or equal to 5% for
SPN-812 were somnolence, fatigue, decreased appetite, headache and
nausea.
“We are pleased with the positive topline results of the P302
study, in which SPN-812 showed statistical significance on the
primary endpoint and main secondary endpoint. It’s exciting to see
a consistency in the data across the first three Phase III
studies,” stated Dr. Stefan Schwabe, Executive Vice President
R&D, Chief Medical Officer of Supernus Pharmaceuticals.
Additional topline data for the P302 study can be accessed by
visiting ‘Events & Presentations’ in the Investor Relations
section on the Company’s website at www.supernus.com.
About SPN-812
SPN-812 is a norepinephrine reuptake inhibitor with selective
serotonin modulation activity 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 a
well-differentiated ADHD treatment compared to other non-stimulant
treatments for ADHD due to its different 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 pharmaceutical company
focused on developing and commercializing products for the
treatment of central nervous system (CNS) diseases. The Company
currently markets Trokendi XR® (extended-release topiramate) for
the prophylaxis of migraine and the treatment of epilepsy, and
Oxtellar XR® (extended-release oxcarbazepine) for the treatment of
epilepsy. The Company is also developing several product candidates
to address large market opportunities in the CNS market, including
SPN-810 for the treatment of Impulsive Aggression in ADHD patients,
SPN-812 for the treatment of ADHD and SPN-604 for the treatment of
bipolar disorder.
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 successfully complete the development of its product
candidates including SPN-812, obtain regulatory approval and
commercially market them; 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; 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
filings with the Securities and Exchange Commission 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.
CONTACT:
Jack A. Khattar, President and CEOGregory S. Patrick, Vice
President and CFOSupernus Pharmaceuticals, Inc.Tel: (301)
838-2591
Or
Investor Contact:Peter VozzoWestwicke PartnersOffice: (443)
213-0505Mobile: (443) 377-4767Email: peter.vozzo@westwicke.com
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