FDA approves GSK’s Lamictal®XR™ (lamotrigine)

GlaxoSmithKline (GSK) announced today 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 anti-epileptic 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.

“We are committed to providing new and effective treatment options for patients,” said Atul Pande, MD, senior vice president, Neurosciences Medicines Development Center, GlaxoSmithKline. “The approval of Lamictal XR for conversion to monotherapy will provide an additional therapeutic option for appropriate patients.”

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 anti-epileptic drug. In ‘conversion to monotherapy’, an additional anti-epileptic drug is added to a patient’s existing anti-epileptic drug therapy regimen while the original therapy is gradually withdrawn.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.

Of the 226 patients treated with Lamictal XR, eight patients reported 10 treatment-emergent serious adverse events, including one serious adverse event of rash. Other serious adverse events were seizure related, trauma, neoplasm, upper gastrointestinal hemorrhage, pyrexia and respiratory failure. No deaths were reported during the study. 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 (n=1 in 300mg/day, n=7 in 250 mg/day group).

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).

About Lamictal XR

Lamictal XR Extended-Release Tablets are approved in the U.S. as adjunctive therapy for partial seizures and primary generalized tonic-clonic seizures in patients 13 years and older.

Safety and effectiveness of Lamictal XR for use in patients less than 13 years of age have not been established.