Investigational Extended-Release Formulation Reduced Seizures in Patients
Who Were Inadequately Controlled
RESEARCH TRIANGLE PARK, N.C., Oct. 15 /PRNewswire-FirstCall/ -- New recently published data show that Lamictal(R)XR(TM) (lamotrigine) Extended- Release Tablets significantly reduced the frequency of partial seizures in inadequately controlled patients with epilepsy.
Lamictal XR is an extended-release formulation of Lamictal(R) (lamotrigine) currently in development as adjunctive therapy for patients with partial epilepsy with or without secondary generalization. Partial seizures, which are the most common form of epilepsy, involve a restricted area of the brain. Secondarily generalized seizures start out affecting only one side of the brain and evolve to affect both sides.
Results from this study, published in the October 16, 2007 edition of Neurology demonstrated that Lamictal XR reduced partial seizures by 46 percent over the entire 19-week treatment period compared to 24 percent with placebo. All patients enrolled in the study were inadequately controlled on one or two antiepileptic drugs. The study also showed that 42 percent of patients treated with Lamictal XR achieved at least a 50 percent reduction in seizure frequency compared to 24 percent of patients receiving placebo, a reduction that was reached by some patients as early as Day 18 of the study and was sustained over the entire 19-week treatment period.
"Many patients require multiple doses of one or more medications to control their epilepsy, which makes taking their medicines correctly and at the right times even more challenging," said Dean Naritoku, M.D., Professor of Neurology and Pharmacology, Southern Illinois University, Springfield, IL. "These data are important as they show investigational Lamictal XR taken once- daily significantly reduced seizure frequency among previously uncontrolled patients.
About This Study
This study was an international, multi-center, randomized, double-blind, placebo-controlled trial of patients naive to Lamictal, 13 years of age or older who were experiencing eight or more partial seizures during the eight- week baseline period despite taking a stable regimen of one or two antiepileptic drugs (AEDs). Two hundred and thirty-nine patients were randomized to receive either once-daily Lamictal XR or placebo (118 Lamictal XR, 121 placebo). The 19-week treatment period of the study consisted of a seven-week Escalation Phase and a 12-week Maintenance Phase.
The study's primary endpoint was median percent reduction from baseline in partial seizure frequency. Study results showed that Lamictal XR significantly reduced partial seizures by 46.1 percent, compared to 24.2 percent with placebo over the entire 19-week treatment period (P=0.0004). The study also showed significant overall reduction in seizure frequency with Lamictal XR in both the Escalation and Maintenance treatment phases of the study (P=0.028 and P=0.0001, respectively).
The percentage of patients who achieved a .50 percent reduction in partial seizure frequency during the 19-week treatment phase of the study was also significantly higher in the Lamictal XR group compared to placebo (42.2 percent versus 24.2 percent). In addition, the time to achieve and maintain a .50 percent reduction in partial onset seizure frequency was significantly shorter for the group treated with Lamictal XR compared to placebo. Statistical significance was evident at Day 18 and was maintained throughout the 19-week treatment phase of the study.
The median percent reduction from baseline in weekly frequency of secondarily generalized seizures was also significantly higher in patients receiving Lamictal XR compared to placebo (55.2 percent vs. 3.2 percent). Similar results were observed for the escalation and maintenance phases of the study.
The percentage of patients with at least one adverse event during the study was 69 percent for Lamictal XR and 62 percent for placebo. The most common adverse events in this study were headache (Lamictal XR, 17 percent vs. placebo, 15 percent) and dizziness (Lamictal XR, 18 percent vs. placebo, 5 percent). Non-serious rash was reported as an adverse event in two patients receiving Lamictal XR and in one patient receiving placebo. One of the two patients taking Lamictal XR withdrew prematurely from the study due to non- serious rash. No serious rashes were observed in either treatment group.
Epilepsy is defined by recurrent unprovoked seizures, or changes in sensation, awareness, or behavior brought about by electrical disturbances in the brain. The kind of seizure a person has depends on which part and how much of the brain is affected by the electrical disturbance that produces seizures. Generalized seizures are seizures that involve the entire brain from the outset. Partial seizures, which are the most common form of epilepsy, involve a restricted area of the brain. In approximately 70 percent of cases, the cause of epilepsy is unknown. According to the Epilepsy Foundation, more than 3 million Americans of all ages are living with epilepsy.
Lamictal XR is an investigational therapy currently under review by the Food and Drug Administration. The immediate-release formulation of Lamictal is indicated 1) as adjunctive therapy for partial seizures, primary generalized tonic-clonic seizures, and the generalized seizures of Lennox-Gastaut syndrome in adults and pediatric patients as young as 2 years and 2) for conversion to monotherapy in adults with partial seizures taking carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single AED.
Safety and effectiveness of Lamictal have not been established 1) as initial monotherapy, 2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate, 3) for simultaneous conversion to monotherapy from two or more concomitant AEDs.
Lamictal is also approved for maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in adult patients treated for acute mood episodes with standard therapy. The effectiveness of Lamictal in the acute treatment of mood episodes has not been established.
Serious rashes requiring hospitalization and discontinuation of treatment have been reported in association with the use of Lamictal. The incidence of these rashes, which have included Stevens-Johnson syndrome, is approximately 0.8 percent (8 per 1000) in pediatric patients under the age of 16 years receiving Lamictal as adjunctive therapy for epilepsy, and 0.3 percent (3 per 1000) in adults on adjunctive therapy for epilepsy. In clinical trials of bipolar and other mood disorders, the rate of serious rash was 0.08 percent of adult patients who received Lamictal as initial monotherapy and 0.13 percent of adult patients who received Lamictal as adjunctive therapy. In a prospectively followed cohort of 1,983 pediatric patients taking adjunctive Lamictal, there was one rash-related death.
GlaxoSmithKline (NYSE: GSK), with U.S. operations in Philadelphia, P.A. and Research Triangle Park, N.C., is one of the world's leading research-based pharmaceutical and healthcare companies. GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better, and live longer. More information on GlaxoSmithKline is available at the company's Web site at http://www.gsk.com.
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