Supernus Receives FDA Tentative Approval for Expanded Label of Trokendi XR® to Include Migraine Prophylaxis in Adults
August 19 2016 - 2:37PM
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 that the Food and Drug Administration (FDA) has
granted tentative approval to the Company’s Supplemental New Drug
Application (sNDA) requesting a label expansion for Trokendi XR to
include prophylaxis of migraine headache in adults.
The approval of the sNDA is tentative because the FDA has
determined that the drug meets all of the required quality, safety,
and efficacy standards for approval, but is subject to the
pediatric exclusivity which expires March 28, 2017. Final approval
may not be made effective until this exclusivity period has
expired.
In addition, the Company announced today that the FDA has
granted final approval to expand the label for Trokendi XR for
monotherapy treatment of partial onset seizures to include adults
and pediatric patients 6 years and older, rather than 10 years and
older.
“We will continue to work with the FDA to gain final approval
upon the expiration of pediatric exclusivity,” stated Jack Khattar,
President and Chief Executive Officer of Supernus Pharmaceuticals.
“We are prepared and ready to launch the migraine indication upon
receiving full FDA approval.”
About Trokendi XR
Trokendi XR is the first approved novel once-daily extended
release formulation of topiramate for the treatment of epilepsy.
Trokendi XR is an antiepileptic drug indicated for initial
monotherapy in patients 6 years of age and older with partial onset
or primary generalized tonic-clonic seizures; adjunctive therapy in
patients 6 years of age and older with partial onset or primary
generalized tonic-clonic seizures; and adjunctive therapy in
patients 6 years of age and older with seizures associated with
Lennox-Gastaut syndrome. The product is available in 25mg, 50mg,
100mg and 200mg extended-release capsules.
For current full prescribing and safety information, click
here
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; 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.
CONTACT:
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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