Supernus Announces FDA Acceptance of sNDA to Add Migraine to Trokendi XR(R) Label
October 22 2015 - 6:21PM
Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN) announced today that
the United States Food and Drug Administration (FDA) has accepted
for review the company's supplemental new drug application (sNDA)
for Trokendi XR®. The application requests FDA approval to expand
the indication for Trokendi XR beyond the current indication for
the treatment of epilepsy to include treatment for adults for
prophylaxis of migraine headache. Under the Prescription Drug User
Fee Act (PDUFA) guidelines, the FDA has set a target date in the
second quarter of 2016 to complete its review.
"Now that our application is under review, we look forward to
working with the FDA to ensure a timely approval of the new
indication," said Jack Khattar, president and chief executive
officer of Supernus Pharmaceuticals. "If approved for use in
migraine, Trokendi XR would represent an important new treatment
option for adult patients suffering from this condition."
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, or CNS, diseases. The Company
markets two products for epilepsy, Oxtellar XR® (extended-release
oxcarbazepine) and Trokendi XR® (extended-release topiramate).
The Company is also developing several product candidates in
psychiatry to address large market opportunities in ADHD, including
ADHD patients with impulsive aggression. These product candidates
include SPN-810 for impulsive aggression in ADHD and SPN-812 for
ADHD.
Forward Looking Statements
This press release contains forward-looking statements regarding
the timing of the Company's ability to market Trokendi XR® for
migraine. Actual results may differ materially from those in these
forward-looking statements as a result of various factors,
including, but not limited to, the Company's ability to obtain
final regulatory approval for the migraine indication,
commercialize its products successfully, whether physicians will
prescribe and patients will use its products, once available, and
competition in their respective markets. For a further description
of these and other risks facing the Company, please see the risk
factors described in the Company's Annual Report Form 10-K that was
filed with the United States Securities and Exchange Commission on
March 12, 2015 under the caption "Risk
Factors". Forward-looking statements speak only as of the date
of this press release, and the Company undertakes no obligation to
update or revise these statements, except as may be required by
law.
CONTACT: Contact:
Jack A. Khattar, President and CEO
Gregory S. Patrick, Vice President and CFO
Supernus Pharmaceuticals, Inc.
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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