FDA grants expanded approval for lacosamide in epilepsy
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The FDA expanded its approval of lacosamide to include adjunctive therapy for primary generalized tonic-clonic seizures as well as an IV formulation for patients aged 4 years and older, according a press release.
Lacosamide — marketed as Vimpat (UCB Inc.) — first received approval in the U.S. as an add-on therapy for partial-onset seizures in adults with epilepsy in 2008. The newest approval follows additional approvals in 2014, as monotherapy for adults, and in 2017 as monotherapy or adjunctive therapy in patients aged 4 years and older with partial-onset seizures.
The FDA based the latest approval of lacosamide for primary generalized tonic-clonic seizures (PGTCS) in part on results from a phase 3 study demonstrating that lacosamide decreased the risk for a second PGTCS during the 24-week treatment period by 45% (P = .001). Lacosamide also resulted in a significantly higher rate of PGTCS freedom during the treatment period compared with placebo (31.3% vs. 17.2%; P = .011).
Findings from the phase 3 study showed that lacosamide was well tolerated in patients with idiopathic generalized epilepsy and PGTCS. Common adverse events occurring in 10% or more of the study population who received the drug included dizziness (23%), somnolence (17%), headache (14%) and nausea (10%) compared with 7%, 14%, 10%, and 6%, respectively, of patients treated with placebo.
"The treatment of primary generalized tonic-clonic (convulsive) seizures is challenging, with about one-third of patients still being refractory while on therapy," David Vossler, MD, FAAN, FACNS, FAES, of the department of neurology at the University of Washington, said in the release. Vossler was involved in the phase 3 study that was partially responsible for this new approval. "Bolstered by a wealth of data demonstrating the efficacy and safety of lacosamide, this new indication gives people suffering from PGTCS a chance at freedom from these seizures, which many have never experienced."