Strong data for GSK's Lamictal in new indication
UK drug major GlaxoSmithKline has welcomed data published in the August 1 issue of Pediatrics showing that its drug Lamictal (lamotrigine) is an effective add-on therapy for the treatment of primary generalized tonic-clonic seizures in a subgroup of children and adolescents.
According to GSK, this is the first published analysis of data from a randomized, double-blind, controlled clinical trial of PGTC seizures focusing on patients two to 20 years of age, adding that Lamictal is not currently indicated for the treatment of this clinical manifestation.
In a subgroup analysis of 45 patients in this young age group, the median percentage decrease from baseline in PGTC seizures during the entire treatment period was 77% among those receiving Lamictal and 40% in the placebo group (p=0.044). GSK noted that median PGTC seizure counts per month were significantly improved for all treatment phases in patients on the drug rather than placebo.
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