Reportedly, in a clinical study, the addition of Lamictal XR reduced seizure frequency more than placebo in patients with uncontrolled primary generalised tonic-clonic seizures, when used in adjunctive therapy for patients 13 years of age and older. The patients in the study were not adequately controlled despite being on one or two anti-epileptic drugs.
The company said that Lamictal XR was initially approved in May 2009 for the treatment of partial onset seizures, with or without secondary generalisation in adults or adolescents. The safety and effectiveness of Lamictal XR have not been established in patients under the age of 13.
Patients with generalised tonic-clonic seizures currently taking immediate-release Lamictal twice-daily, can be converted directly to once-a-day Lamictal XR using the same total daily dose.
Victor Biton, director of the Arkansas Epilepsy Program and Clinical Trials, said: “We were encouraged that the study showed such a reduction in the number of primary generalised tonic-clonic seizures in patients who received Lamictal XR in addition to their current regimen. Over the 19 week treatment period, the median percent reduction in weekly seizure frequency was 75% in patients treated with Lamictal XR compared to 32% for those taking placebo. The approval of once-a-day Lamictal XR for this very serious seizure type gives us a convenient and effective new option for improving the care of our patients with epilepsy.”