ATLANTA, Dec. 9 /PRNewswire-FirstCall/ -- UCB today announced findings from new studies of the once-daily antiepileptic drug (AED) Keppra XR(TM) (levetiracetam) extended-release tablets comparing tolerability versus levetiracetam immediate release (IR) and reporting on additional dosing schedules. The data were among five studies that were presented at the 62nd annual meeting of the American Epilepsy Society (AES) in Seattle.
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Keppra XR was approved by the U.S. Food and Drug Administration in September 2008 for use as adjunctive treatment for people with partial-onset seizures who are 16 years of age and older.
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"In this new meta-analysis, patients taking Keppra XR experienced fewer nervous system side effects than those taking the same dose of twice daily levetiracetam," said James Zackheim, Medical Director, CNS, UCB. "Keppra XR is the only once-daily, extended-release formulation of levetiracetam, and there is no generic alternative available."
Summary of Keppra XR Data Presented at 2008 AES Annual Meeting
Safety Profile of Levetiracetam Extended Release Compared to Immediate Release: An Indirect Comparison Using a Meta-Analytic Approach
Researchers conducted a meta-analysis of Phase III data to determine whether Keppra XR is associated with any tolerability advantages versus the same daily dose of levetiracetam IR. According to the meta-analysis, patients taking Keppra XR once-daily had lower rates of some adverse events versus levetiracetam IR twice-daily.
-- In terms of overall tolerability, 52.8% of Keppra XR patients reported any adverse event, compared with 79% of patients taking levetiracetam IR.
-- While adverse events associated with levetiracetam IR were also observed with Keppra XR, patients treated with Keppra XR once-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 to dissolve the total amount of drug needed to achieve the same concentration as that found in the blood).
-- When the 2 x 750 mg Keppra XR dose was taken with food, the time to peak concentration was increased by 2 hours relative to fasted intake, while Cmax (the peak concentration of a drug in the body) remained within bioequivalence limits.
-- For all three Keppra XR dosing schedules (3 x 500 mg, 2 x 750 fasted and 2 x 750 fed), tolerability was good and the rates of treatment-emergent adverse events were similar across all groups; in addition, adverse events were virtually all mild, and all resolved by the end of the study.
Poster Session 3, Monday, December 8, 8:00 am - 1:30 pm (Abstract 3.239)
Christian Otoul, Elisabeth Rouits, Ingrid Burton, Evelyne Guenole, Mona Troenaru, Ans Valgaeren, Pierre Boulanger, Maria Laura Sargentini-Maier
UCB Pharma SA, Braine-L'Alleud, Belgium; Department of Pharmacokinetics, SGS Life Science Services, Wavre, Belgium; Therapharm Recherches, Caen, France
Additional Keppra XR Data Presented at 2008 AES Annual Meeting:
-- Population Pharmacokinetics of Levetiracetam Extended-Release 500 mg Tablets
Poster Session 3, Monday, December 8, 8:00 am - 1:30 pm (Abstract 3.247)
Elisabeth Rouits, M. Lovern, Maria Laura Sargentini-Maier and Armel Stockis
UCB Pharma, Braine-L'Alleud, Belgium
-- Population Dose-Response Modeling of Levetiracetam Extended- and Immediate-Release Formulations in Adults with Partial-Onset Seizures
Poster Session 3, Monday, December 8, 8:00 am - 1:30 pm (Abstract 3.25)
Rik Schoemaker, Eric Snoeck, Armel Stockis, Christian Otoul, Maria Laura Sargentini-Maier
Exprimo NV, Mechelen, Belgium; Pharmacometrics Department, UCB Pharma SA, Braine-L'Alleud, Belgium
-- Dose-Proportionality of Levetiracetam 500 mg Extended-Release Tablets from 1 g to 3 g Once Daily
Poster Session 3, Monday, December 8, 8:00 am - 1:30 (Abstract 3.263)
Ans Valgaeren, Nathalie Toublanc, Ingrid Burton, Sandrine Gelu-Mantoulet, Mona Troenaru, Christian Otoul, Maria Laura Sargentini-Maier, Armel Stockis
UCB Pharma SA, Braine-L'Alleud, Belgium; Department of Pharmacokinetics, SGS Life Science Services, Wavre, Belgium; Therapharm Recherches, Caen, France
Keppra XR cannot be substituted with any IR levetiracetam or any other antiepileptic medication at the pharmacy counter without a physician's approval.
Important Safety Information
Keppra XR(TM) extended-release tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in patients 16 years of age and older with epilepsy.
Keppra XR(TM) causes somnolence, dizziness, and behavioral abnormalities. The most common adverse reactions observed with Keppra XR(TM) in combination with other AEDs were somnolence and irritability.
The adverse reactions that may be seen in patients receiving Keppra XR(TM) are expected to be similar to those seen in patients receiving immediate-release Keppra(R) tablets.
Keppra(R) immediate-release tablets cause somnolence and fatigue, coordination difficulties, and behavioral abnormalities (e.g., psychotic symptoms, suicidal ideation, and other abnormalities), as well as hematological abnormalities. In adults experiencing partial onset seizures, the most common adverse reactions observed with Keppra(R) in combination with other AEDs were somnolence, asthenia, infection and dizziness.
Keppra XR(TM) should be gradually withdrawn to minimize the potential of increased seizure frequency.
Dosing must be individualized according to the patient's renal function status. In patients with end-stage renal disease on dialysis, it is recommended that immediate-release Keppra(R) be used instead of Keppra XR(TM).
For full prescribing information, please see www.KeppraXR.com.
In order to ensure patient access to this valuable medication in the U.S., UCB is initiating a co-pay support program. For more information, contact U.S. UCB Medical Information at 1-866-822-0068 (press 9).
About Epilepsy
Epilepsy is a chronic neurological disorder affecting approximately three million people in the U.S. -- making it more common than multiple sclerosis and Parkinson's disease combined. It is caused by abnormal, excessive electrical discharges of the nerve cells, or neurons, in the brain. Epilepsy is characterized by a tendency to have recurrent seizures and defined by two or more unprovoked seizures. There are many different seizure types and epileptic syndromes. Forty percent of patients taking only one AED continue to experience seizures, and approximately 30% of patients taking adjunctive therapy continue to experience seizures. This highlights the ongoing need for the development of new AEDs. For more information about epilepsy, visit www.epilepsyfoundation.org, www.epilepsy.com, or www.epilepsyadvocate.com.
About UCB
UCB is a global leader in the biopharmaceutical industry dedicated to the research, development and commercialization of innovative medicines with a focus on the fields of central nervous system and immunology disorders. Employing approximately 12,000 people in more than 40 countries, UCB achieved revenue of 3.6 billion euro in 2007. UCB is listed on NYSE Euronext (symbol: UCB). Worldwide headquarters is located in Brussels, Belgium; U.S. headquarters is located in Atlanta, Georgia. For more information about UCB, visit www.ucb-group.com.
Forward looking statement
This press release contains forward-looking statements based on current plans, estimates and beliefs of management. Such statements are subject to risks and uncertainties that may cause actual results to be materially different from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, effects of future judicial decisions, changes in regulation, exchange rate fluctuations and hiring and retention of its employees.
Further information Andrea Levin Public Relations Manager, CNS, UCB Phone: 770-970-8352 Email: [email protected]
SOURCE UCB
