Oxtellar XR® (oxcarbazepine) Clinical Information

These images are fictionalized for illustrative purposes only.

Powerful, Established Efficacy with Oxtellar XR®1,2

Clinically significant partial seizure reduction and partial seizure freedom rates in the 2400 mg group1-3

Study design1-3

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

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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.

Partial Seizure Freedom Rates

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

Oxtellar XR (oxcarbazepine) Adverse Events

  • 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

 

MHD Plasma Concentration for Oxtellar XR 1200 mg QD in Healthy Adults at Steady State1,3

Single-center, multiple-dose, open-label, randomized, 2-treatment crossover study1

Oxtellar XR MHD Plasma Concentration

  • Slow rate of rise1
  • Continued absorption throughout the day1
  • Low peak-to-trough fluctuation1,3

 

 

 

 

 

 

References

  1. Data on file. Supernus Pharmaceuticals, Inc. Rockville, MD.
  2. 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.
  3. Oxtellar XR [package insert]. Rockville, MD: Supernus Pharmaceuticals, Inc.; December 2015.