On September 25, 2006, the FDA approved a new use of the antiepileptic drug (AED), Lamictal (R)(lamotrigine) Tablets for the treatment of Primary Generalized Tonic-Clonic (PGTC) seizures, formerly called “grand-mal” seizures. With this new indication, Lamictal is now approved as add-on therapy to treat PGTC seizures in children aged 2 and older as well as adults.

The FDA approval was based on a multicenter, placebo-controlled trial in pediatric (age 2 and older) and adult patients (n=117). In the study, Lamictal was given to patients whose PGTC seizures were not well-controlled, despite taking other AEDs. Patients with partial seizures were excluded from this particular study .Over the entire treatment period of the study, Lamictal reduced PGTC seizures by 66% compared to 34% for the placebo group, which was statistically significant (p=0.006). Similar effects were seen during the titration and maintenance phases of the study. Significantly more patients receiving Lamictal as maintenance therapy experienced at least a 50% reduction compared to placebo (72% versus 49%, p<0.05).Efficacy was similar across age groups.

To learn more go to: http://us.gsk.com/news/archive.htm and http://www.epilepsy.com/medications/b_lamictal_intro.html.