Supernus Announces Publication of Phase III Study (PROSPER) Results on
ROCKVILLE, Md. -- February 3, 2014
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
“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 1200mg and 2400mg 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 2400mg (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%; 1200mg: −34.5%,
P=0.02; 2400mg: −52.7%, P=0.006) in the North American study site
cluster. A concentration–response analysis also supported a clinically
meaningful effect for 1200mg. 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, 301-838-2591
President and CEO
Gregory S. Patrick, 301-838-2591
Vice President and CFO
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