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Lamotrigine Now Available in Orally Disintegrating Tablet

RESEARCH TRIANGLE PARK, N.C., May 11 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE:GSK) announced today that the U.S. Food and Drug Administration (FDA) has approved Lamictal(R) ODT(TM) (lamotrigine) Orally Disintegrating Tablets. Lamictal ODT uses a novel drug-delivery formulation to provide Lamictal in a tablet that has a pleasant taste and disintegrates on the tongue.

One factor physicians should consider when treating chronic disorders is whether patients can swallow the medications they need. In one large survey study, 23 percent of patients in a general practice setting reported difficulty swallowing.

"Patients with epilepsy or bipolar disorder can have difficulty swallowing tablets. Unfortunately, this problem may go unrecognized, because many patients don't discuss this issue with their healthcare providers," said Daniel Lieberman, M.D., associate professor and clinical director of the George Washington University Department of Psychiatry and Behavioral Sciences. "Orally disintegrating tablets, like Lamictal ODT, offer an option for patients who have difficulty swallowing tablets."

Lamictal ODT was approved based on the demonstrated bioequivalence of Lamictal ODT to Lamictal Tablets and was developed in collaboration with Eurand N.V. (NASDAQ:EURX) . Lamictal ODT is the only antiepileptic treatment that is available in an orally disintegrating formulation.

Lamictal ODT is indicated for the long-term treatment of Bipolar I Disorder to lengthen the time between mood episodes in people 18 years or older who have been treated for mood episodes with other medicine. It is not known if Lamictal ODT is safe or effective in children or teenagers under the age of 18 with mood disorders such as bipolar disorder or depression. Lamictal ODT is also used together with other medicines to treat certain types of seizures (partial seizures, primary generalized tonic-clonic seizures, generalized seizures of Lennox-Gastaut syndrome) in people two years or older or alone when changing from other medicines used to treat partial seizures in people 16 years or older. It is not known if Lamictal ODT is safe or effective when used alone as the first treatment of seizures in adults.

Lamictal ODT will be available in 25 mg, 50 mg, 100 mg, and 200 mg strengths and is expected to be available in pharmacies in early July. For patients switching from Lamictal Tablets to the ODT formulation, the recommended dose of Lamictal ODT matches the dose of Lamictal Tablets. For patients new to Lamictal, Patient Titration Kits containing five weeks of treatment will be available. Lamictal ODT will also be available in four Maintenance Packs, one Pack for each dose strength. These Packs each contain 30 tablets and are designed to help make it easy for patients to keep up with their daily dose.

Source: GlaxoSmithKline

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