Lamictal is an anti-seizure medication that will now be used to treat Primary Generalized Tonic-Clonic (PGTC) seizures as a result of the approval. With this new indication, Lamictal can now be used as add-on therapy to treat PGTC seizures in children aged 2 and older as well as adults.
This new use marks the fifth FDA approval for Lamictal in epilepsy, making it one of the few antiepileptic drugs with established efficacy in a broad spectrum of seizure types, including partial and generalized seizures. Lamictal is also approved as maintenance therapy for adults with bipolar I disorder.
“Primary generalized tonic-clonic seizures represent one of the most serious forms of epilepsy and one in which additional effective treatments are needed,” said Victor Biton, Director of the Arkansas Epilepsy Program. “There are few treatments approved for generalized seizures and fewer approved for both PGTC and partial seizures.”
PGTC seizures are the most common type of generalized seizures, occurring in approximately 20% of patients with epilepsy. These seizures usually occur without warning and are associated with wide-ranging physical and behavioral changes with potentially life-threatening complications.
“PGTC seizures can be a scary and dangerous experience, especially for young children and their parents,” said Edwin Trevathan, Director of the Division of Pediatric and Developmental Neurology at Washington University School of Medicine, “Since generalized seizures are more common in children than in adults, and since there have been very few new medications approved for use in primary generalized tonic-clonic seizures, this approval is particularly important.”