FDA Approves Lamictal(R)XR(TM); An Extended-Release Once-Daily, New Generation Treatment fo...(ther Lamictal XR or placebo. The treat...),Health

Study results showed that the new once-daily, extended-release formulation of Lamictal XR reduced partial seizures by 47 percent, compared to 25 percent with placebo over the entire 19-week treatment period (P=0.0001).

A second study, COMPASS, was an open-label study evaluating the conversion from the immediate-release form of Lamictal given twice daily to the same total daily dose of Lamictal XR given once daily in 44 patients 13 years or older with epilepsy. Patients enrolled in the study were divided into three treatment groups based on the type of adjunctive antiepileptic drug they were taking. The rate at which Lamictal clears the bloodstream varies depending upon the other antiepileptic drugs a patient may be taking at the same time. The study results from COMPASS showed that patients could be switched from the immediate-release formulation of Lamictal taken twice daily to the same total daily dose of Lamictal XR taken once daily while maintaining comparable minimum blood levels of lamotrigine, regardless of the other antiepileptic medicines being taken concurrently.

The most common adverse events in the ARMOR study are presented above in the About Lamictal XR section. The most common drug-related adverse event in the COMPASS study was headache. No serious rashes were observed in either treatment group in both the ARMOR and COMPASS studies. However, the risk of serious rash caused by Lamictal XR is not expected to differ from that of with the immediate-release formulation of Lamictal. The prescribing information for Lamictal XR contains a boxed warning on serious rash that is further described in the About Lamictal XR section above.

GlaxoSmithKline - one of the wo
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