Abstract Details

Title Efficacy and Tolerability of SPN-804, a Novel, Once-Daily, Extended-Release Formulation of Oxcarbazepine: Adjunctive Treatment of Refractory Partial Seizures in a North American Subpopulation

Topic Epilepsy

Presentation(s) P02 - (-)

Poster/Presentation
Number 213

Objective

Background BACKGROUND: A novel, extended-release formulation of oxcarbazepine, SPN-804 is a once-daily antiepilepsy treatment. Overall aggregate study results across 8 countries showed a significant primary endpoint difference vs placebo for SPN-804 2400 mg/d (P=0.003) and a trend toward significance with 1200 mg/d (P=0.078). We conducted the following subanalysis in North American sites to identify any differences in response by geography.

Design/Methods DESIGN/METHODS: Adults 18-65y with refractory partial epilepsy despite 1-3 concomitant antiepilepsy drugs (AEDs) were enrolled. Seizure frequency was assessed over 4-8 weeks (inclusion: minimum 3 seizures/28d). Patients were randomized to receive SPN-804 1200 mg/d, 2400 mg/d, or placebo while continuing stable AEDs. SPN-804 was titrated to target dose over 4 weeks, then maintained for 12 weeks. Primary endpoint was median percentage change in partial seizure frequency per 28d from baseline (PCHT). Secondary endpoints included seizure-free rates and safety assessments.

Results RESULTS: Of 366 intent-to-treat patients, 116 (31.7%) were studied in Canada, Mexico, and the US (mean age, 38.9y; 45.7% male). Both SPN-804 doses provided significant reductions in median PCHT vs placebo (1200 mg/d: -34.50, P=0.022; 2400 mg/d: -52.65, P=0.006; placebo: -13.30). In the maintenance period, 17% (2400 mg/d), 5% (1200 mg/d), and 2% (placebo) achieved seizure freedom. No new adverse events or safety signals were evident.

Conclusions CONCLUSIONS: SPN-804 1200 mg/d and 2400 mg/d were significantly superior to placebo in reducing partial seizure frequency in this North American subpopulation. Seizure reduction for placebo in this subgroup was <50% of that in the total population (-28.70), perhaps contributing to differences between full and subpopulation analyses. Secondary end point results generally supported primary results. SPN-804 is an effective, well-tolerated option for adjunctive treatment of partial seizures in adults.

Authors/Disclosures
Janet Johnson PRESENTER	No disclosure on file
Scott Brittain (Supernus Pharmaceuticals, Inc.)	No disclosure on file
	No disclosure on file
	No disclosure on file

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