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New Keppra XR(TM) Data Highlight Its Role for Patients with Partial-Onset Seizures
Date:12/9/2008

-daily experienced statistically significantly lower rates of adverse events related to nervous system disorders (i.e., headache, somnolence and dizziness) versus levetiracetam IR twice-daily.

-- Keppra XR-treated patients reported numerically lower rates of psychiatric disorders (i.e., nervousness, anxiety and depression) and nutrition/metabolism disorders.

--No other differences in rates of adverse events were statistically significant.

Poster Session 3, Monday, December 8, 8:00 am - 1:30 pm(Abstract 3.243)

Florent Richy, MPH, PhD, Soutrik Banerjee, MD, PhD, Christophe Gervasoni, MS, Patricia Grossman, PharmD, MBA, Sandra Helmers, MD

UCB Pharma, Inc.; University of Liege, Belgium; Joseph Fourier University, France; Stendhal University, France; Emory University Hospital, USA

Single Dose Bioequivalence between Levetiracetam 2 x 750 mg XR Tablets and 3 x 500 mg XR Tablets and Food Effect on 2 x 750 mg XR Tablets in Healthy Subjects

This study demonstrated that an investigational 750 mg tablet strength of Keppra XR is bioequivalent to the approved 500 mg tablet when these are each combined to achieve a 1,500 mg dose. Results show that a single dose of 2 x 750 mg Keppra XR tablets was bioequivalent to a 3 x 500 mg single dose of Keppra XR in healthy adults, and that food intake did not significantly modify Keppra XR 2 x 750 mg disposition.

-- The median time to peak plasma concentration was approximately 4 to 5 hours for each dose.

-- Each dose resulted in a similar half-life (the time required for half the quantity of a drug in the body to be metabolized or eliminated), apparent total clearance (the rate at which a drug in the body is metabolized or eliminated), and apparent total distribution (the amount of fluid that would be required t
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SOURCE UCB
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