RESEARCH TRIANGLE PARK, N.C., April 25, 2011 /PRNewswire/ -- 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drug is added to a patient's existing anti-epileptic drug therapy regimen while the original therapy is gradually withdrawn.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 LamictalXRLamictal 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.
Important Safety InformationPrescription Lamictal XR Extended-Release Tablets are not for everyone. LamictalXR may cause a serious skin rash that may cause patients to be hospitalized or to stop LamictalXR; 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 patients begin 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 patients take Lamictal XR while taking valproate [Depakene* (valproic acid) or Depakote* (divalproex sodium)], take a higher starting dose of Lamictal XR than their healthcare provider prescribed, or increase their dose of Lamictal XR faster than prescribed.
LamictalXR 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 patients to decide if they should continue taking Lamictal XR.
LamictalXR 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 worry the patient (see Medication Guide).LamictalXR may rarely cause aseptic meningitis, a serious inflammation of the protective membrane that covers the brain and spinal cord. Patients should call their healthcare provider right away if they have any of the following symptoms: headache, fever, nausea, vomiting, stiff neck, rash, unusual sensitivity to light, muscle pains, chills, confusion, or drowsiness.
Meningitis has many causes other than Lamictal XR, which a doctor would check for if a patient developed meningitis while taking Lamictal XR.
Patients should not stop taking Lamictal XR without talking to their healthcare provider. Stopping Lamictal XR suddenly may cause serious problems.
Patients should always check that they receive LamictalXR.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 LamictalXR. Taking the wrong medication can cause serious health problems. When a healthcare provider gives a patient a prescription for Lamictal XR, the patient should:
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, patients 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 more information, patients should ask their healthcare provider or pharmacist.
For more information about Lamictal XR please see the full Prescribing Information, including Boxed Warning at www.gsk.com.
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*Depakene and Depakote are registered trademarks of Abbott Laboratories.Cautionary statement regarding forward-looking statementsUnder 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 2010.Registered in England & Wales:No. 3888792Registered Office:980 Great West Road
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