FDA Approves Lamictal XR for Monotherapy
April 25, 2011
RESEARCH TRIANGLE PARK, N.C., April 25, 2011-- GlaxoSmithKline (GSK) announced that the U.S. Food and Drug Administration (FDA) has approved Lamictal® XR™ (lamotrigine) Extended-Release Tablets for conversion to monotherapy in patients 13 years and older with partial seizures taking one antiepileptic drug. This is a new indication for Lamictal XR, which is already approved as add-on treatment for partial seizures and primary generalized tonic-clonic seizures in patients in this age group. Safety and effectiveness of Lamictal XR have not been established as initial monotherapy or for simultaneous conversion to monotherapy from two or more concomitant AEDs.
The approval was based on data from study LAM30055, an international, multicenter, historical control study evaluating 300 mg/day and 250 mg/day of Lamictal XR for conversion to monotherapy in patients 13 years and older with partial seizures taking one antiepileptic drug. In "conversion to monotherapy," an additional antiepileptic drug is added to a patient's existing antiepileptic drug therapy regimen while the original therapy is gradually withdrawn. LAM30055 used a historical control based on a pooled analysis of previously conducted conversion to monotherapy studies.
Four percent of patients treated with 300 mg/day and 10 percent treated with 250 mg/day discontinued treatment due to adverse events. The only adverse event leading to withdrawal in more than one patient was rash. Treatment-emergent adverse events were reported by 53 percent and 61 percent of patients in the 300 mg/day and 250 mg/day groups, respectively. The most common adverse events occurring in at least 5 percent of patients in either the 300 mg/day or 250 mg/day treatment group, respectively, were: headache (26 and 28 percent), dizziness (11 and 9 percent), rash (4 and 11 percent), nasopharyngitis (6 and 6 percent), nausea (5 and 5 percent), somnolence (4 and 5 percent) and insomnia (0 and 5 percent).
Source: PR Newswire
Reviewed by Epilepsy Foundation Professional Advisory Board Member Brian Alldredge, PHARM.D.