Supernus Submits New Drug Application for SPN-812 for the Treatment of ADHD
November 11 2019 - 3:15PM
Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical
company focused on developing and commercializing products for the
treatment of central nervous system (CNS) diseases, today announced
that it has submitted a New Drug Application (NDA) to the U.S. Food
and Drug Administration (FDA) for SPN-812 for the treatment of
patients with attention deficit hyperactivity disorder
(ADHD).
SPN-812 is a well differentiated product candidate that, if
approved by the FDA, can become a unique multi-symptom treatment
option for many patients with ADHD. It is a non-controlled
substance that is easy to use and that has shown in clinical
studies a reduction in ADHD symptoms observed as early as week one
and continued until the end of the studies.
“This NDA submission is an important milestone in the
development of SPN-812, which if approved by the FDA, has the
potential of becoming the first novel treatment to be introduced in
the ADHD market in more than a decade,” said Jack A. Khattar,
President and Chief Executive Officer of Supernus Pharmaceuticals.
“In addition, SPN-812 represents the foundation on which we will be
building a strong presence in psychiatry.”
The NDA for SPN-812 includes data from an extensive development
program consisting of four Phase III clinical trials that studied
the pediatric patient population from the age of 6 to 17 years, two
Phase II clinical trials, several Phase I trials, long-term open
label extension study, preclinical testing, and drug manufacturing
data.
In addition, we announced last week that we initiated a Phase
III program to study SPN-812 in the adult ADHD patient
population.
About SPN-812
SPN-812 is a serotonin norepinephrine modulating agent (SNMA)
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 treatments for ADHD due to its novel mechanism of
action and 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 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-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 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; 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,
Senior Vice President and CFOSupernus Pharmaceuticals, Inc.Tel:
(301) 838-2591
Or
Investor Contact:Peter VozzoWestwicke, an ICR CompanyOffice:
(443) 213-0505Mobile: (443) 377-4767Email:
peter.vozzo@westwicke.com
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