Powerful, Established Efficacy with Oxtellar XR®1,2
Clinically significant partial seizure reduction and partial seizure freedom rates in the 2400 mg group1-3
Multinational, multicenter, double-blind, randomized, placebo-controlled, 3-arm, parallel-group, phase 3 trial of 366 adult patients having a diagnosis of epilepsy with uncontrolled partial seizures with or without secondary generalization, taking a stable regimen of 1 to 3 concomitant antiepileptic drugs (AEDs), experiencing an average of 6 partial seizures per 28 days
The most commonly observed (≥5%) adverse reactions seen in association with the Oxtellar XR 2400 mg/day group and more frequently than in placebo-treated patients were (2400 mg/day v placebo): dizziness (41% v 15%), headache (15% v 7%), vomiting (15% v 9%), somnolence (14% v 9%), diplopia (13% v 4%), balance disorder (7% v 5%), asthenia (7% v 1%), fatigue (3% v 1%), and tremor (1% v 2%)2,3
Reduction = median percentage reduction, treatment phase, as adjunctive therapy in controlled phase 3 clinical trial in refractory epilepsy.
Abbreviation: ITT, intent to treat.
Established Safety Profile1-3
Adverse events occurring in ≥5% of adult patients receiving Oxtellar XR with concomitant AEDs and more frequent than with placebo1-3
- Cognitive adverse events were similar to placebo1
- Incidence of nausea was similar to placebo: 12%
(2400 mg/day), 12% (1200 mg/day), and 12% (placebo)2
- Incidence of clinically significant hyponatremia was similar to placebo: 0.8% (2400 mg/day), 1.6%
(1200 mg/day), and 0% (placebo)3
- For a complete listing of adverse events ≥2%, see the full Prescribing Information
- Discontinuation rate due to adverse events was 30% in the 2400 mg/day treatment group, 15% in the 1200 mg/day treatment group, and 8% in the placebo group2
- Data on file. Supernus Pharmaceuticals, Inc. Rockville, MD.
- French JA, Baroldi P, Brittain ST, Johnson JK; on behalf of PROSPER Investigators Study Group. Efficacy and safety of extended-release oxcarbazepine (Oxtellar XR™) as adjunctive therapy in patients with refractory partial-onset seizures: a randomized controlled trial. Acta Neurol Scand. 2014;129:143-153.
- Oxtellar XR [package insert]. Rockville, MD: Supernus Pharmaceuticals, Inc.; December 2015.