Healthcare Industry News: UCB
News Release - April 10, 2009
New Keppra XR(TM) Dosage Strength Offers Simplified Treatment Option for People Living With Partial-Onset SeizuresATLANTA, April 10 -- (Healthcare Sales & Marketing Network) -- Once-daily Keppra XR(TM) (levetiracetam) extended-release tablets are now available in a new dosage strength--750 mg--enabling doctors to simplify patients' treatment plans by decreasing the number of tablets they take each day.
According to studies published in Epilepsy & Behavior and Neurology, patients are more likely to adhere to their medication regimen when it is taken once daily, and therefore may be more likely to reach the goal of epilepsy therapy--seizure freedom with minimal side effects.
Keppra XR(TM), from UCB, The Epilepsy Company(TM), was approved last year as an add-on therapy for partial-onset seizures in patients who are 16 years of age and older with epilepsy. Keppra XR(TM) is the only extended-release formulation of levetiracetam and cannot be substituted with generic levetiracetam, immediate-release levetiracetam or any other antiepileptic medication at the pharmacy counter.
Keppra XR(TM) was approved by the U.S. Food and Drug Administration (FDA) based on data from an international clinical study of 158 epilepsy patients with partial-onset seizures who added 1,000 mg of Keppra XR(TM) or placebo to their other epilepsy medications once daily. The study consisted of an 8-week baseline period followed by a 12-week treatment period.
- The study showed that 10.1 percent of Keppra XR(TM) patients experienced complete partial-onset seizure freedom vs. 1.3 percent in the placebo group over the treatment period.
- Keppra XR(TM) patients experienced a 46.1 median percent reduction in weekly partial-onset seizure frequency versus 33.4 percent in the placebo group.
Treatment with Keppra XR(TM) should be initiated with a dose of 1,000 mg once daily. The daily dosage may be adjusted in increments of 1,000 mg every two weeks, to a maximum recommended dose of 3,000 mg per day.
Keppra XR(TM) 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 Keppraź (levetiracetam) tablets.
Keppraź 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 Keppraź 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 Keppraź be used instead of Keppra XR(TM). Please see Keppra.com for Keppraź immediate-release tablets full prescribing information.
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).
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. Less than half of patients (47 percent) will attain seizure control with their first AED, and more than 30 percent will continue to experience seizures despite trying two or more AEDs. This highlights the ongoing need for the development of new AEDs. For more information about epilepsy, visit http://www.epilepsyfoundation.org/, http://www.epilepsy.com/, or www.epilepsyadvocate.com.
Andrea Levin, Public Relations Manager, CNS, UCB U.S.
T +1.770.970.8352, Andrea.email@example.com
UCB, Brussels, Belgium (www.ucb.com) is a biopharmaceutical company dedicated to the research, development and commercialization of innovative medicines with a focus on the fields of central nervous system and immunology disorders. Employing more than 10 000 people in over 40 countries, UCB aims to achieve revenues of 3.3 billion euro in 2008. UCB is listed on Euronext Brussels (symbol: UCB). UCB U.S. headquarters is based in Atlanta.
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