Drug maker GlaxoSmithKline said it has received an approval for LamictalXR from the U.S. Food and Drug Administration for the treatment of tonic-clonic seizures as an once-a-day, add-on therapy for epilepsy in patients aged 13 years and older. The drug is already approved for partial onset seizures for patients in this age group.
The addition of LamictalXR to therapy for patients 13 years of age and older, reduced seizure frequency more than placebo in patients with uncontrolled primary generalized tonic-clonic seizures in the study.
Victor Biton, director of the Arkansas Epilepsy Program and Clinical Trials, Inc., in Little Rock, Arkansas said, "We were encouraged that the study showed such a significant reduction in the number of primary generalized 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 percent in patients treated with Lamictal XR compared to 32 percent for those taking placebo."
Also known as "grand mal" seizures, primary generalized tonic-clonic seizures, are most common form of seizure occurring in approximately 20% of patients with epilepsy. Usually, patients experiencing a generalized tonic-clonic seizure lose consciousness and, collapse following which they experience muscle stiffening (the tonic phase) and then jerking involving both sides of the body (the clonic phase).
Lamictal XR may cause a serious skin rash that may cause the patient to be hospitalized or to stop the drug, though it may rarely cause death. Lamictal XR can also cause other types of allergic reactions or serious problems which may affect organs and other parts of the body like the liver or blood cells.
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The addition of LamictalXR to therapy for patients 13 years of age and older, reduced seizure frequency more than placebo in patients with uncontrolled primary generalized tonic-clonic seizures in the study.
Victor Biton, director of the Arkansas Epilepsy Program and Clinical Trials, Inc., in Little Rock, Arkansas said, "We were encouraged that the study showed such a significant reduction in the number of primary generalized 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 percent in patients treated with Lamictal XR compared to 32 percent for those taking placebo."
Also known as "grand mal" seizures, primary generalized tonic-clonic seizures, are most common form of seizure occurring in approximately 20% of patients with epilepsy. Usually, patients experiencing a generalized tonic-clonic seizure lose consciousness and, collapse following which they experience muscle stiffening (the tonic phase) and then jerking involving both sides of the body (the clonic phase).
Lamictal XR may cause a serious skin rash that may cause the patient to be hospitalized or to stop the drug, though it may rarely cause death. Lamictal XR can also cause other types of allergic reactions or serious problems which may affect organs and other parts of the body like the liver or blood cells.
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