Supernus Announces Publication of Phase III Study (PROSPER) Results on Oxtellar XR®
February 03 2014 - 6:30AM
Business Wire
Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN), a specialty
pharmaceutical company, today announced the publication of the
Prospective, Randomized Study of Oxcarbazepine extended release in
Subjects with Partial Epilepsy Refractory (PROSPER) data on
Oxtellar XR. Results of this Phase III pivotal trial will appear in
the upcoming March issue of Acta Neurologica Scandinavica, Volume
129, Issue 3, pages 143–153 and is available online at
http://onlinelibrary.wiley.com/doi/10.1111/ane.12207/abstract.
“We are pleased to see the PROSPER study results published in a
renowned peer-reviewed journal in neurology such as Acta
Neurologica Scandinavica. This represents the first publication for
Supernus in such a journal, allowing physicians to have access to
the study results. The publication highlights the important role
Oxtellar XR can play in improving the lives of patients with
epilepsy. These results mirror those seen in numerous patient cases
since the launch of our product,” said Jack A. Khattar, President
and CEO of Supernus.
The PROSPER study evaluated and demonstrated the safety and
efficacy of our novel once-daily 1200 mg and 2400 mg
doses of Oxtellar XR when added to 1-3 concomitant antiepileptic
drugs in adults with refractory partial-onset seizures, with or
without secondary generalization. Oxtellar XR also showed the
potential to improve tolerability when compared to what is known
about the immediate release versions of oxcarbazepine.
This was the Phase III pivotal study that formed the basis of
approval by the FDA. It was a randomized, double-blind,
parallel-group, placebo controlled study conducted at 88 sites in
eight countries throughout North America and Eastern Europe. The
primary efficacy endpoint was median percent reduction from
baseline in monthly (28-day) seizure frequency for the 16-week
double-blind treatment period in the intent-to-treat (ITT)
population with analyzable seizure data. Other efficacy analyses
included proportion of patients with ≥ 50% seizure reduction,
proportion of patients that are seizure free, and the relationship
between clinical response and plasma concentration.
Median percent reduction was significant for once-daily Oxtellar
XR compared to placebo at 2400 mg (P = 0.003). In
the placebo, 1200mg/day and 2400mg/day treatment groups,
respectively, responder rates were 28.1%, 36.1% (P = 0.08), and
40.7% (P = 0.02); 16-week seizure-free rates in a pragmatic ITT
analysis were 3.3%, 4.9% (P = 0.59), and 11.4% (P = 0.008). Post
hoc analyses demonstrated that both Oxtellar XR dosages were
significantly superior to placebo in median percent seizure
reduction (placebo: −13.3%; 1200 mg: −34.5%,
P = 0.02; 2400 mg: −52.7%, P = 0.006) in
the North American study site cluster. A concentration–response
analysis also supported a clinically meaningful effect for
1200 mg. Adverse event frequency was consistent with a
pharmacokinetic profile of Oxtellar XR producing lower peak plasma
concentrations versus oxcarbazepine immediate-release. Once-daily
dosing was not associated with any new safety signals.
About Oxtellar XR®
Oxtellar XR is the only approved novel once-daily extended
release formulation of oxcarbazepine for the treatment of epilepsy.
It is an antiepileptic drug indicated for adjunctive therapy in the
treatment of partial seizures in adults and in children 6 to 17
years of age. The product is available in 150 mg, 300 mg and 600 mg
extended-release tablets.
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, or CNS, 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 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 potential of Oxtellar XR, its safety and efficacy profile.
Actual results may differ materially from those in these
forward-looking statements as a result of various factors,
including, but not limited to, risks regarding the company's
ability to commercialize the product successfully, whether
physicians will prescribe and patients will use the product, and
competition in the market. 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
15, 2013 and under the caption "Risk Factors" and the updates to
these risk factors in the Company's quarterly report form 10-Q that
was filed with the Commission on August 14, 2013. 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.
Supernus Pharmaceuticals, Inc.Jack A. Khattar,
301-838-2591President and CEOorGregory S. Patrick, 301-838-2591Vice
President and CFOorInvestors:COCKRELL
GROUP877-889-1972investorrelations@thecockrellgroup.comwww.cockrellgroup.com
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