November 5, 2008
Keppra XR(TM) Offers Convenient Dosing For People With Partial Onset Seizures
ATLANTA, Nov. 5 /PRNewswire/ -- press release, regulated information: UCB announced today that Keppra XR(TM) offers convenient dosing for people with epilepsy. Keppra XR(TM) was approved by the U.S. Food and Drug Administration (FDA) in September 2008 for use as an add-on to other antiepileptic treatments for people with partial-onset seizures who are 16 years of age and older.
While many people with epilepsy are successfully treated with one or more of the currently available antiepileptic drugs, a significant percentage still live with uncontrolled seizures or intolerable side effects.
A recent online survey of 451 people living with epilepsy showed that almost half missed at least one dose of their epilepsy medication in the last month, and 37 percent who missed a dose reported having a breakthrough seizure. More than 80 percent of these people missed a dose of an antiepileptic drug (AED) that was taken multiple times daily and the most common reason reported for having missed a dose was forgetfulness. The survey was conducted by UCB.
Keppra XR(TM) offers once-daily dosing and is made specifically for epilepsy. Keppra XR(TM) is the only extended-release formulation of levetiracetam, and there is no generic version available.
UCB - The Epilepsy Company(TM)
"The launch of Keppra XR(TM) is the first of many upcoming milestones for UCB's epilepsy franchise," said Rich Denness, vice president & general manager, CNS, UCB. "At UCB, we are committed to developing innovative treatments for epilepsy and improving the lives of people and their families living with this condition."
The immediate release tablet form of Keppra(R) (levetiracetam) was first approved by the FDA in 1999 as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. Since then, Keppra(R) has become a leading antiepileptic drug in the U.S.
In addition, a new epilepsy therapy, Vimpat(R) (lacosamide) was approved by the FDA in late October 2008 and will be commercially available in early 2009. Vimpat(R) is approved for use as an add-on therapy for the treatment of partial-onset seizures in people with epilepsy who are 17 years and older.
About the Survey
The online survey was conducted by UCB. Email invitations were sent to 4,000 randomly selected email addresses from a database. Survey responses were limited to 500 complete responses in order to achieve a minimum 95 percent confidence interval, 5 percent margin of error and 50 percent proportion. The 500 responses were collected and validated, resulting in 451 usable respondents.
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 Keppra(R) (levetiracetam) 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). Please see Keppra.com for Keppra(R) immediate-release tablets full prescribing information.
For full prescribing information, please see http://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).
Important Safety Information about Vimpat(R) in the U.S.
AEDs, including Vimpat(R), increase the risk of suicidal behavior and ideation in patients taking these drugs. Patients should be monitored for the emergence or worsening of depression, suicidal thoughts, or behavior and/or any unusual changes in mood or behavior. Patients should be advised that Vimpat(R) may cause dizziness, ataxia, and syncope. Caution is advised for patients with known cardiac conduction problems, who are taking drugs known to induce PR interval prolongation, or with severe cardiac disease. In patients with seizure disorders, Vimpat(R) should be gradually withdrawn to minimize the potential of increased seizure frequency. Multiorgan sensitivity reactions have been reported with anticonvulsants. If this reaction is suspected, Vimpat(R) should be discontinued and an alternative treatment started.
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 (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 http://www.epilepsyadvocate.com/.
Further information Andrea Levin, Public Relations Manager, CNS, UCB Group. T +1.770.970.8352, [email protected] About UCB
UCB (Brussels, Belgium, http://www.ucb-group.com/) is a global leader in the biopharmaceutical industry dedicated to the research, development and commercialization of innovative medicines with focus on the fields of central nervous system and immunology disorders. Employing around 12,000 people in over 40 countries, UCB achieved revenue of EUR 3.6 billion in 2007. UCB is listed on Euronext Brussels (symbol: UCB).
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.
CONTACT: Andrea Levin, Public Relations Manager, CNS, of UCB Group,+1-770-970-8352, [email protected]
Web Site: http://www.keppraxr.com/