Supernus Provides Update on Trokendi XR® Migraine sNDA and Reiterates Guidance
June 16 2016 - 4:30PM
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 it remains in discussions with the FDA
regarding its Supplemental New Drug Application, or sNDA, for
migraine. The FDA requested that the Company resubmit the Trokendi
XR product label with migraine as an indication in a different
format prior to completing its review. No additional new data,
studies or analyses for efficacy or safety were requested by the
FDA.
The Company will resubmit the revised label before the end of
June, and a new PDUFA date will be assigned by the FDA. At this
point, the Company believes that such a PDUFA date is likely to be
in the third quarter of 2016.
“Supernus is ready to launch the new indication, and a launch
later this year or next year should not have any material effect on
our business,” stated Jack Khattar, President and Chief Executive
Officer of Supernus Pharmaceuticals. “Upon final approval for
prophylaxis of migraine headache in adults, we believe Trokendi XR
will represent an important new treatment option for adult patients
suffering from this condition.”
For full year 2016, the Company reiterates its guidance for net
product sales to range from $200 million to $210 million, and
operating income to range from $28 million to $35 million.
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 10 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 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 patients with ADHD 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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