FDA Approves Once-Daily Levetiracetam as Adjunctive Therapy for Partial Onset Seizures

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Title: FDA Approves Once-Daily Levetiracetam as Adjunctive Therapy for Partial Onset Seizures
URL: http://www.pslgroup.com/dg/22C20A.htm
Doctor's Guide
September 15, 2008

NEW YORK -- September 15, 2008 -- The US Food and Drug Administration (FDA) has approved levetiracetam extended-release tablets (Keppra XR) for use as adjunctive therapy for patients with partial onset seizures aged 16 years and older.

"With solid clinical trial data supporting [levetiracetam] efficacy and tolerability, this once-daily antiepileptic drug can play an important role in treating people with epilepsy," said lead investigator Jukka Peltola, MD, Department of Neurology, Tampere University Hospital, Tampere, Finland.

"We found in the clinical trial that [levetiracetam] provided significant partial onset seizure control in once-daily dosing when added to other antiepileptic drugs and that it was generally well-tolerated."

Levetiracetam causes somnolence, dizziness, and behavioural abnormalities. The most common adverse reactions observed with levetiracetam in combination with other antiepileptic drugs were somnolence and irritability.

SOURCE: UCB

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