Brivaracetam, which is currently under review by the U.S. FDA, is effective and well-tolerated in patients with partial-onset seizures (POS), according to research published in Epilepsia.
The selective synaptic vesicle protein 2A ligand is in development as adjunctive treatment for POS in adults 16 years and older.
In this phase 3, randomized, double-blind, placebo-controlled study, researchers sought to confirm the efficacy, safety, and tolerability of brivaracetam in the target population. Seven hundred sixty-eight patients with uncontrolled POS despite ongoing treatment with one to two antiepileptic drugs were randomized to either placebo (n=259), brivaracetam 100 mg/d (n=252), or brivaracetam 200 mg/d (n=249). All patients participated in an eight-week prospective baseline period followed by a 12-week treatment period, without up-titration.
Researchers observed a 22.8% reduction in 28-day seizure frequency for patients randomized to brivaracetam 100 mg/d (13.3–31.2%; P< 0.001) compared to placebo, and a 23.2% reduction in patients randomized to brivaracetam 200 mg/d (13.8–31.6%; P< 0.001) compared to placebo. The ≥50% responder rate was 21.6% for placebo, 38.9% brivaracetam 100 mg/d (2.39; 1.6–3.6; P< 0.001), and 37.8% for brivaracetam 200 mg/d (2.19; 1.5–3.3; P< 0.001). Adverse events occurred in 155 (59.4%) of placebo patients and 340 (67.6%) of patients taking brivaracetam. Discontinuation rates due to adverse events were 3.8% for placebo, 8.3% for brivaracetam 100 mg/d, and 6.8% for brivaracetam 200 mg/d. The most common adverse events included somnolence (7.7% placebo vs. 18.1% brivaracetam), dizziness (5% vs. 12.3%), and fatigue (3.8% vs. 9.5%).
In all, four phase 3 studies have been conducted to evaluate the efficacy and safety of the drug, with a dose range of 5 mg-200 mg/d. In this study, adjunctive brivaracetam therapy (100, 200 mg/d) was effective in reducing POS in patients 16 years and older without concomitant levetiracetam use and was well-tolerated in the patient population.