RESEARCH TRIANGLE PARK, NC, September 25, 2006 -- The Food and Drug Administration today approved a new use of the anti-seizure medicine Lamictal (lamotrigine) Tablets for the treatment of one of the most serious forms of epilepsy -- Primary Generalized Tonic-Clonic (PGTC) seizures, also known as "grand mal" seizures. 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, M.D., Director of the Arkansas Epilepsy Program, Little Rock, AR, a key investigator for the clinical study supporting this indication. "There are few treatments approved for generalized seizures and fewer approved for both PGTC and partial seizures. The approval of lamotrigine as add-on therapy for patients with PGTC seizures is a testament to the drug's broad spectrum of activity in the treatment of epilepsy."
PGTC seizures are the most common type of generalized seizures, occurring in approximately 20 percent 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. People who experience PGTC seizures become stiff, lose consciousness, and jerk repetitively. Patients may fall to the ground, bite their tongue, and lose bladder control. Serious injury, including broken bones, can occur. The seizure will typically last for a few minutes and then be followed by a perio
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