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11.18.20

FDA Approves Lacosamide for Primary Generalized Tonic-Clonic Seizures and Expanded Pediatric Use

  • KEYWORDS:
  • Epilepsy
  • FDA Approvals
  • primary generalized tonic-clonic seizure
  • Seizures

The Food and Drug Administration (FDA) has approved lacosamide (Vimpat; UCB, Atlanta, GA) as adjunctive therapy for primary generalized tonic-clonic seizures (PGTCS) in children age 4 years or more and lacosamide injection for intravenous use. Results from a phase 3 study (NCT02477839) show lacosamide was generally tolerated in children with idiopathic generalized epilepsy (IGE) and PGTCS.

Results of the study were recently published in the Journal of Neurology, Neurosurgery & Psychiatry and showed that adjunctive treatment with lacosamide lowered the risk of developing a second PGTCS during the 24-week treatment period, with risk reduction of 45% (P=.001) and a significantly higher rate of freedom from PGTCS during the treatment period compared with placebo (31.3% vs 17.2%, P=.011).

"These approvals underscore UCB's commitment to people living with epilepsy and our focus on finding solutions for specific unmet needs within the epilepsy community," said Mike Davis, Head of US Neurology at UCB. "We are pleased that lacosamide is now available as a treatment option for people living with primary generalized tonic-clonic seizures on their journey to seizure control. 

The phase 3 study enrolled 242 participants (≥4 years of age) with idiopathic generalized epilepsy (IGE) who were randomly assigned 1:1 to receive lacosamide or placebo (twice daily) in addition to their usual epilepsy treatment. Of all types of epilepsies, IGEs make up 20% to 40% and are characterized by different forms of generalized seizures (eg, absence, myoclonic, and PGTCS). Generalized tonic-clonic seizures are associated with an increased risk of injury, and having 3 or more in a year increases is associated with a fifteen times more likely occurrence of sudden unexpected death in epilepsy (SUDEP).

The most common adverse reactions (≥10%) reported in participants treated with lacosamide were dizziness (23%), somnolence (17%), headache (14%), and nausea (10%) compared to 7%, 14%, 10%, and 6%, respectively, of participants who received placebo.
 

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