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FDA Approves Once-A-Day Lamictal(R)XR(TM) as Add-On Epilepsy Therapy for Primary Generalized Tonic-Clonic Seizures

January 29, 2010

RESEARCH TRIANGLE PARK, N.C., Jan. 29 /PRNewswire-FirstCall/ — GlaxoSmithKline (NYSE: GSK) announced today that the U.S. Food and Drug Administration has approved Lamictal®XR(TM) (lamotrigine) Extended-Release Tablets as once-a-day, add-on therapy for epilepsy in patients ages 13 years and older with primary generalized tonic-clonic seizures. This is an expanded label, as Lamictal XR is approved for partial onset seizures (with or without secondary generalization) for patients in this age group.

Primary generalized tonic-clonic seizures, known formerly as “grand mal” seizures, are considered the most common form of generalized (affecting both sides of the brain) seizure, occurring in approximately 20 percent of patients with epilepsy. Patients experiencing a generalized tonic-clonic seizure usually lose consciousness and collapse. This is followed by muscle stiffening (the tonic phase) and then jerking involving both sides of the body (the clonic phase).

In a clinical study, the addition of Lamictal XR reduced seizure frequency more than placebo in patients with uncontrolled primary generalized tonic-clonic seizures, when used in adjunctive therapy for patients 13 years of age and older. The patients in the study were not adequately controlled despite being on one or two anti-epileptic drugs.

“We were encouraged that the study showed such a significant reduction in the number of primary generalized tonic-clonic seizures in patients who received Lamictal XR in addition to their current regimen. Over the 19 week treatment period, the median percent reduction in weekly seizure frequency was 75 percent in patients treated with Lamictal XR compared to 32 percent for those taking placebo,” said Victor Biton, M.D., director of the Arkansas Epilepsy Program and Clinical Trials, Inc., in Little Rock, Ark. “The approval of once-a-day Lamictal XR for this very serious seizure type gives us a convenient and effective new option for improving the care of our patients with epilepsy.”

The most common adverse event was headache, which was reported among 14 percent of patients taking Lamictal XR and 16 percent of patients taking placebo. Other common adverse events in patients taking Lamictal XR included vomiting (10 percent), nausea (7 percent), fever (7 percent), dizziness (6 percent), double vision (6 percent), tremor (6 percent), nasopharyngitis (3 percent), rash (3 percent) and anxiety (3 percent).

Lamictal XR was initially approved in May 2009 for the treatment of partial onset seizures with or without secondary generalization in adults or adolescents. Partial onset seizures, which are limited to one part of the brain, are the most common type of seizure experienced by people with epilepsy. Partial seizures may sometimes spread to both sides of the brain, an occurrence classified as secondary generalization. The safety and effectiveness of Lamictal XR have not been established in patients under the age of 13.

Patients with generalized tonic-clonic seizures currently taking immediate-release Lamictal twice-daily can be converted directly to once-a-day Lamictal XR using the same total daily dose.

Patented GlaxoSmithKline Extended-Release Technology

Lamictal XR Extended-Release Tablets are enteric-coated and contain a modified release formulation in the center of the tablet. There is a specially designed opening in the enteric coating on both sides of the tablet that utilizes a new technology called DiffCORE(TM), discovered and developed by GlaxoSmithKline. This allows a controlled release of the medicine in the acidic environment of the stomach, leading to a gradual release of lamotrigine into the bloodstream.

Safety Information

Prescription Lamictal XR Extended-Release Tablets are not for everyone.

Lamictal XR may cause a serious skin rash that may cause the patient to be hospitalized or to stop Lamictal XR; it may rarely cause death. There is no way to tell if a mild rash will develop into a more serious reaction. These serious skin reactions are more likely to happen when the patient begins taking Lamictal XR, within the first two to eight weeks of treatment. But it can happen in people who have taken Lamictal XR for any period of time. Children between 2 to 16 years of age have a higher chance of getting this serious skin reaction while taking lamotrigine. Lamictal XR is not approved for use in children less than 13 years old.

The risk of getting a rash is higher if the patient: takes Lamictal XR while taking valproate [Depakene* (valproic acid) or Depakote* (divalproex sodium)], takes a higher starting dose of Lamictal XR than a healthcare provider prescribed, or increases the dose of Lamictal XR faster than prescribed.

Lamictal XR can also cause other types of allergic reactions or serious problems which may affect organs and other parts of the body like the liver or blood cells. Patients may or may not have a rash with these types of reactions.

Patients should call their healthcare provider right away if they have any of the following: a skin rash, hives, fever, swollen lymph glands, painful sores in the mouth or around the eyes, swelling of the lips or tongue, yellowing of the skin or eyes, unusual bruising or bleeding, severe fatigue or weakness, severe muscle pain, or frequent infections. These symptoms may be the first signs of a serious reaction. A healthcare provider should examine the patient to decide if they should continue taking Lamictal XR.

Like other antiepileptic drugs, Lamictal XR may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Patients should call a healthcare provider right away if they have worsening depression, any unusual changes in mood or behavior, or thoughts or actions about suicide or self-harm, especially if they are new, worse, or worrisome.

Patients prescribed Lamictal have sometimes been given the wrong medicine because many medicines have names similar to Lamictal, so patients should always check that they receive Lamictal XR.

Taking the wrong medication can cause serious health problems. When a healthcare provider prescribes Lamictal XR, patients should:

  • Make sure they can read it clearly.
  • Talk to their pharmacist to check that they are being given the correct medicine.
  • Each time they fill their prescription, check the tablets against the pictures of the tablets in the Medication Guide that comes with their prescription.

Patients should not take Lamictal XR if they have had an allergic reaction to lamotrigine or to any of the inactive ingredients in Lamictal XR.

Common side effects include dizziness, tremor, double vision, nausea, vomiting, trouble with balance and coordination and anxiety. Other common side effects that have been reported with another form of Lamictal include headache, sleepiness, blurred vision, runny nose, and rash. Patients should tell their healthcare provider about any side effect that bothers them or does not go away. Also, they should tell their healthcare provider if they have any changes in menstrual pattern, such as breakthrough bleeding, while taking Lamictal XR and birth control pills. These are not all the possible side effects of Lamictal XR.

For full prescribing information for Lamictal XR, including Boxed Warning, please visit www.gsk.com.

Editor’s Note: About the Clinical Trial

The approval of Lamictal XR (lamotrigine) as add-on therapy for primary generalized tonic-clonic seizures was based upon data from a 19-week, international, multicenter, double-blind, randomized, placebo-controlled study in 143 patients 13 years of age and older (n = 70 on Lamictal XR and n = 73 on placebo). Patients with at least three primary generalized tonic-clonic seizures during an eightweek baseline phase were randomized to 19 weeks of treatment with Lamictal XR or placebo added to their current antiepileptic drug (AED) regimen of up to two drugs. Patients were dosed on a fixed-dose regimen, with target doses ranging from 200 mg/day to 500 mg/day of Lamictal XR based on concomitant AED(s) (target dose = 200 mg for valproate, 300 mg for AEDs not altering plasma lamotrigine, and 500 mg for enzyme-inducing AEDs).

The primary efficacy endpoint was percent change from baseline in primary generalized tonic-clonic seizure frequency during the double-blind treatment phase. For the intent-to-treat population, the median percent reduction in primary generalized tonic-clonic seizure frequency was 75 percent in patients treated with Lamictal XR and 32 percent in patients treated with placebo, a difference that was statistically significant, defined as a two sided p value < 0.05.

The proportion of patients achieving any particular level of reduction in primary generalized tonic-clonic seizure frequency was consistently higher for the group treated with Lamictal XR compared with the placebo group. For example, 70 percent of patients randomized to Lamictal XR experienced a 50 percent or greater reduction in primary generalized tonic-clonic seizure frequency, compared with 32 percent of patients randomized to placebo.

The most common adverse event was headache, which was reported among 14 percent of patients taking Lamictal XR and 16 percent of patients taking placebo. Other common adverse events in patients taking Lamictal XR included vomiting (10 percent), nausea (7 percent), fever (7 percent), dizziness (6 percent), double vision (6 percent), tremor (6 percent), nasopharyngitis (3 percent), rash (3 percent) and anxiety (3 percent).

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.

*Depakene and Depakote are registered trademarks of Abbott Laboratories.

GlaxoSmithKline cautionary statement regarding forward-looking statements

Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK’ s operations are described under ‘Risk Factors’ in the ‘Business Review’ in the company’ s Annual Report on Form 20-F for 2008.

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SOURCE GlaxoSmithKline


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