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Sep 25, 2006

New Drug Approved for Primary Generalized Tonic-Clonic Seizures

  • GlaxoSmithKline’s antiseizure drug, Lamictal® (lamotrigine), was approved for a new epilepsy indication—one of the most serious forms of epilepsy, primary generalized tonic-clonic (PGTC) seizures. Lamictal can now be used as an add-on therapy for PGTC, or grand mal seizures, in children two years and older, as well as adults.

    “Since generalized seizures are more common in children than in adults, and since there have been very few new medications approved for use in primary generalized tonic-clonic seizures, this approval is particularly important,” points out Edwin Trevathan, M.D., an investigator on this clinical study and director of the division of pediatric and developmental neurology at Washington University School of Medicine and neurologist-in-chief, St. Louis Children’s Hospital.

    This is the fifth use for Lamictal in epilepsy, making it one of the few antiepileptic drugs with established efficacy in a broad spectrum of seizure types, including partial and generalized seizures, notes GlaxoSmithKline.

    “Primary generalized tonic-clonic seizures represent one of the most serious forms of epilepsy and one in which additional effective treatments are needed,” adds Victor Biton, M.D., director of the Arkansas Epilepsy Program and another investigator on the clinical study. “There are few treatments approved for generalized seizures and fewer approved for both PGTC and partial seizures. The approval of lamotrigine as add-on therapy for patients with PGTC seizures is a testament to the drug’s broad spectrum of activity in the treatment of epilepsy.”

    The approval was based on a multicenter, placebo-controlled trial in 117 volunteers, including children, age two and older, and adults. Lamictal was given to patients on one or two other antisiezure drugs whose seizures were still not well controlled. Patients with partial seizures were excluded.

    The study found Lamictal effectively reduced the frequency of PGTC seizures. Over the entire treatment period, Lamictal reduced PGTC seizures by 66%, compared to 34% for the placebo group (p=0.006). In addition, 72% of the patients receiving Lamictal as a maintenance therapy experienced at least a 50% reduction, compared to 49% in the placebo group. Overall, Lamictal was well tolerated.



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