Supernus Provides Regulatory Update for SPN-830
April 08 2024 - 8:00AM
Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical
company focused on developing and commercializing products for the
treatment of central nervous system (CNS) diseases, today announced
a regulatory update for SPN-830. SPN-830 is an investigational
apomorphine infusion device for the continuous treatment of motor
fluctuations (“off” episodes) in Parkinson’s disease (PD) under
U.S. Food and Drug Administration (FDA) review.
The FDA has issued a Complete Response Letter
(CRL) in response to the Company’s New Drug Application (NDA) for
SPN-830. The CRL indicates that the review cycle for the
application is complete, but that the application is not ready for
approval in its present form.
The CRL mentions two areas that require
additional review by the FDA or additional information to be
provided to the FDA. The first area relates to product quality. The
Company recently submitted additional product quality data to the
FDA which it has not yet reviewed. The second relates to the master
file for the infusion device which is proprietary to the device
manufacturer. The Company plans to discuss with the device
manufacturer the provision of the requested information and the
steps required for the resubmission of the NDA for SPN-830. No
clinical safety or efficacy issues were identified as a requirement
for approval. The FDA completed in February 2024 a successful
preapproval inspection of the device manufacturer’s facility.
“We remain committed to bringing SPN-830 to the
market as an important treatment option for PD patients who
experience motor fluctuations associated with off episodes. We will
work with the FDA to address the CRL and to successfully resubmit
our SPN-830 NDA,” said Jack Khattar, President & CEO of
Supernus.
About Supernus Pharmaceuticals,
Inc.
Supernus Pharmaceuticals, Inc. is a
biopharmaceutical company focused on developing and commercializing
products for the treatment of central nervous system (CNS)
diseases.
Our diverse neuroscience portfolio includes
approved treatments for epilepsy, migraine, ADHD, hypomobility in
Parkinson’s disease (PD), cervical dystonia, chronic sialorrhea,
dyskinesia in PD patients receiving levodopa-based therapy, and
drug-induced extrapyramidal reactions in adult patients. We are
developing a broad range of novel CNS product candidates including
new potential treatments for hypomobility in PD, epilepsy,
depression, and other CNS disorders.
For more information, please visit
www.supernus.com.
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 and the products of its subsidiaries; the Company’s
ability to increase its net revenue; the Company’s ability to
commercialize its products and the products of its subsidiaries;
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-830; the Company’s ability to
protect its intellectual property and the intellectual property of
its subsidiaries 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 including SPN-830; 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 including SPN-830; 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; the Company’s ability to
increase the number of prescriptions written for each of its
products and the products of its subsidiaries; the Company’s
ability to increase its net revenue from its products and the
products of its subsidiaries; 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.
CONTACTS:
Jack A. Khattar, President and CEO Timothy C. Dec, Senior Vice
President and CFOSupernus Pharmaceuticals, Inc.Tel: (301)
838-2591
or
INVESTOR CONTACT:
Peter VozzoICR WestwickeOffice: (443) 213-0505Email:
peter.vozzo@westwicke.com
Supernus Pharmaceuticals (NASDAQ:SUPN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Supernus Pharmaceuticals (NASDAQ:SUPN)
Historical Stock Chart
From Apr 2023 to Apr 2024