Supernus Receives Final FDA Approval for Trokendi XR® for Migraine Prophylaxis in Adults and Adolescents
06 April 2017 - 8:44AM
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 final approval to the Company’s Supplemental New Drug
Applications (sNDAs) requesting a label expansion for Trokendi XR
to include prophylaxis of migraine headache in adults and
adolescents 12 years and older. Supernus was granted tentative
approval of one of the two sNDAs in August 2016, with final
approval subject to the pediatric exclusivity of the innovator’s
drug in the adolescent population, which expired March 28, 2017.
Based on IMS prescription data, Topiramate is the most
prescribed drug for the treatment of migraine prophylaxis with more
than 9 million prescriptions annually. This represents
approximately 50% of all IMS prescriptions written for migraine
prophylaxis.
“This approval and our imminent launch in migraine represent an
opportunity for Supernus to further strengthen its leadership
position in this market with Trokendi XR,” stated Jack Khattar,
President and Chief Executive Officer of Supernus Pharmaceuticals.
“Trokendi XR, with its novel formulation, provides full 24 hour
coverage for patients with smooth pharmacokinetics compared to the
immediate-release topiramate products, making it an important new
treatment option for adult and adolescent patients suffering from
migraine headache. This is an important advancement for patients
and another step towards realizing the full potential of Trokendi
XR.”
About Trokendi XR
Trokendi XR is a novel once-daily extended release formulation
of topiramate for the treatment of epilepsy, and migraine
prophylaxis. Trokendi XR is indicated for the prophylaxis of
migraine headache in adults and adolescents 12 years of age and
older, 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 contains forward-looking statements regarding
the Company’s ability to market Trokendi XR® in the migraine
market. Actual results may differ materially from those in these
forward-looking statements as a result of various factors,
including, but not limited to, the ability of the Company to
increase the number of prescriptions written for each of its
products and the Company's ability to increase its net revenue. For
a further description of these and other risks facing the Company,
please see the risk factors described in the Company’s 2016 Annual
Report Form 10-K that was filed with the United States Securities
and Exchange Commission on March 16, 2017 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:
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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