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Supernus Pharmaceuticals, Inc.
, 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.
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