Boston, MA, May 1, 2007 -- Data from two clinical trials presented today at the American Academy of Neurology (AAN) meeting suggest that an investigational once daily extended release formulation of Lamictal (lamotrigine) is effective as add-on treatment in patients with partial epilepsy with and without secondary generalization. Lamictal XR Extended-Release Tablets are currently in development for the treatment of epilepsy. If approved, it will be the first extended release, new generation epilepsy treatment taken once-daily.
Data from the ARMOR study, an international, multi-center, randomized, double-blind, placebo-controlled trial, showed that the new once-daily, extended release formulation reduced partial seizures by 46 percent, while patients taking placebo experienced a reduction of 24 percent over the entire 19-week treatment period. The study also showed significant overall reduction in seizure frequency in both the escalation and maintenance treatment phases. In addition, the study showed that 42 percent of patients treated with Lamictal XR reduced their frequency of seizures by at least half by the end of the 19-week treatment period.
The second study, COMPASS, showed that patients could be switched from Lamictal immediate release (IR) to Lamictal XR while maintaining comparable blood levels of lamotrigine.
"These data are important because they show that the extended release formulation of Lamictal reduces the frequency of seizures. The once daily dosing regimen may also provide a more convenient treatment option for patients," said Dean Naritoku, M.D., Professor of Neurology and Pharmacology, Southern Illinois University, Springfield, IL. "In addition, when compared to Lamictal immediate release, given twice a day, the new investigational formulation demonstrated fewer daily fluctuations in serum concentration and more stable blood levels over time."
ABOUT THE ARMOR STUDY