The Food and Drug Administration (FDA) has approved Vimpat® (lacosamide; UCB) as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older.
The approval was based on data from a double-blind, placebo-controlled phase 3 study that included patients 4 years of age and older with idiopathic generalized epilepsy experiencing primary generalized tonic-clonic (PGTC) seizures. The study included a 12-week historical baseline period, a 4-week prospective baseline period, and a 24-week treatment period.
Patients were randomized to receive lacosamide (n=121) or placebo (n=121) if they were on a stable dose of 1-3 antiepileptic drugs and experienced at least 3 PGTC seizures during the 16-week combined baseline period. The primary end point of the study was the time to second PGTC seizure during the 24-week treatment period.
Results showed that the risk of developing a second PGTC seizure was 45.2% lower among patients treated with lacosamide compared with placebo (hazard ratio: 0.548; [95% CI, 0.381-0.788]; P =.001). Moreover, a greater percentage of patients in the lacosamide group did not experience a PGTC seizure during the 24-week treatment period (31.3% vs 17.2% of the placebo group; adjusted difference: 14.1%; [95% CI, 3.2-25.1]; P =.011).
Additionally, the FDA approved Vimpat Injection for use in pediatric patients 4 years of age and older; previously, this formulation was only indicated for use in adults. The safety of Vimpat Injection was evaluated in an open-label study of 77 pediatric patients 4-17 years of age with epilepsy. Findings from the study showed no serious or severe adverse reactions; adverse reactions associated with Vimpat Injection in this patient population are expected to be similar to those in adults.
Vimpat, a Schedule V controlled substance, is also indicated for the treatment of partial-onset seizures in patients 4 years of age and older. In addition to the tablet (50mg, 100mg, 150mg, 200mg) and injection (200mg/20mL) formulations, the product is available as a 10mg/mL oral solution.
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1. UCB’s VIMPAT® (lacosamide) CV now approved by FDA for primary generalized tonic-clonic seizures and expanded pediatric use for people living with epilepsy. [press release]. November 17, 2020.
2. Vimpat® [package insert]. Smyrna, GA: UCB; 2020.