GSK wins FDA approval for dissolvable version of epilepsy drug

GlaxoSmithKline has received the FDA’s approval for Lamictal ODT 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, said GlaxoSmithKline (GSK).

Lamictal ODT was approved based on the demonstrated bioequivalence of Lamictal ODT to Lamictal tablets and was developed in collaboration with Eurand. Lamictal ODT is the only antiepileptic treatment that is available in an orally disintegrating formulation, claims GSK.

Lamictal ODT will be available in 25mg, 50mg, 100mg, and 200mg strengths and is expected to be available in pharmacies in early July 2009. 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, said GSK.

According to GSK, 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.