For the Media:

FDA Approves New Use for Seizure Drug Lamictal^®

Earlier this week, the Food and Drug Administration approved the use of lamotrigine, or Lamictal^®, (manufactured by GlaxoSmithKline ) as an adjunctive therapy for children (2-20 years) and adults who experience grand mal seizures, also known as primary generalized tonic-clonic (PGTC) seizures. Approximately 20 percent of people with epilepsy experience these types of seizures, which are more common in children than in adults.

“This approval provides another important treatment option for children and adults who suffer from epilepsy. We applaud the FDA for making this therapeutic option available,” said Eric Hargis, President and CEO of the Epilepsy Foundation.

Few treatments are approved for PGTC seizures, particularly for children. Fewer still can be used to treat both generalized and partial seizures. Grand mal seizures involve the entire body and result in muscle stiffness, muscle contractions and loss of consciousness. This type of seizure is more common in children than adults, and the approval of Lamictal adds to the choice of available options for treating this type of seizures.

The FDA's decision was based on a recent study that revealed promising data on the use of Lamictal^® as an adjunctive therapy for patients aged 2-20 years with PGTC seizures. The approval marks the fifth time the FDA has granted a marketing extension for the drug's use in combating epilepsy.

Researchers conducted a randomized, double-blind, placebo-controlled clinical trial to study the efficacy of adjunctive therapy with Lamictal ® on a subgroup of children. The trials indicated that grand mal seizures declined by 66 percent in patients receiving Lamictal. Patients receiving a placebo experienced a 34 percent decline.

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The Epilepsy Foundation, a national non-profit with affiliated organizations throughout the United States, has led the fight against epilepsy since 1968. The Foundation’s goals are to ensure that people with seizures are able to participate in all life experiences; and to prevent, control and cure epilepsy through research, education, advocacy and services. For additional information, please visit www.epilepsyfoundation.org.