Data on Keppra XR® (levetiracetam) extended release tablets and Brivaracetam will also be presented
ATLANTA, Nov. 30, 2010 /PRNewswire/ -- New data on UCB's anti-epileptic drug (AED) Vimpat® (lacosamide) C-V will be presented at the 64th annual meeting of the American Epilepsy Society (AES), taking place at the San Antonio Convention Center in San Antonio, Texas from December 3 to 7. Data will also be presented on Keppra XR and the investigative epilepsy therapy, brivaracetam.
Vimpat® tablets and injection were launched in the U.S. in May 2009 as an add-on therapy for the treatment of partial-onset seizures (POS) in people with epilepsy who are 17 years and older. Vimpat® injection is a short-term replacement when oral administration is not feasible in these patients. Vimpat® oral solution was launched in June 2010. The availability of the oral tablets, oral solution, and intravenous (IV) injection allows for consistent treatment in a hospital setting. The maximum recommended daily dose for Vimpat® in the U.S. is 400 mg/day.
Keppra XR® was approved in September 2008 as an add-on therapy for POS in patients who are 16 years of age and older with epilepsy. UCB is investigating brivaracetam as an adjunctive treatment of POS in adults with epilepsy. Brivaracetam is not currently approved by the U.S. Food and Drug Administration.
Following is a guide to UCB-sponsored posters for Vimpat®, Keppra XR® and brivaracetam to be presented at the AES annual meeting. Additional UCB-sponsored data will be presented during a scientific exhibit on Sunday, December 5, 8 AM-11 AM EST.
To schedule an interview with an investigator, please contact Andrea Levin at 404.483.7329 or [email protected].
Vimpat® (lacosamide) C-V:
1. Improved Seizure Severity, Health-Related Quality of Life and Health Status Reported by Patients During Long-Term Treatment with Lacosamide
Abstract 1.262, Saturday, December 4, Noon - 2:00 pm, Hall A, Street Level
2. Long-Term Safety of Lacosamide as Adjunctive Therapy in Subjects With Uncontrolled POS: Results from a Phase III Open-Label Extension Trial
Abstract 1.265, Saturday, December 4, Noon - 2:00 pm, Hall A, Street Level
3. Long-term Efficacy of Lacosamide as Adjunctive Therapy in Subjects with Uncontrolled POS: Results from a Phase III Open-Label Extension Trial
Abstract 1.263, Saturday, December 4, Noon - 2:00 pm, Hall A, Street Level
4. Investigation of Lacosamide Binding to Collapsin Response Mediator Protein-2 (CRMP-2)
Abstract 1.247, Saturday, December 4, Noon - 2:00 pm, Hall A, Street Level
5. Safety of Lacosamide Monotherapy in Migraine Prophylaxis, Fibromyalgia, and Osteoarthritis: Placebo-controlled Evaluations
Abstract 1.284, Saturday, December 4, Noon - 2:00 pm, Hall A, Street Level
6. Lacosamide Does Not Alter Bone Densitometry Parameters in Juvenile Dogs
Abstract 2.191, Sunday, December 5, Noon - 2:00 pm, Hall A, Street Level
7. Levetiracetam Extended-Release Conversion to Monotherapy for the Treatment of Patients with Partial-Onset Seizures: A Double-Blind, Randomized, Multicenter, Historical Control Study
Abstract 1.282, Saturday, December 4, Noon - 2:00 pm, Hall A, Street Level
8. Pharmacokinetics, Safety and Tolerability of Levetiracetam Extended-Release in Children and Adults with Epilepsy
Abstract 1.278, Saturday, December 4, Noon - 2:00 pm, Hall A, Street Level
9. UCB Antiepileptic Drug Pregnancy Registry
Abstract 1.257, Saturday, December 4, Noon - 2:00 pm, Hall A, Street Level
10. The Impact of Standardization on the Magnitude of Treatment Effect When Analyzing Log-Transformed Seizure Outcome
Abstract 1.256, Saturday, December 4, Noon - 2:00 pm, Hall A, Street Level
11. Adjunctive Brivaracetam in Adults with Uncontrolled Generalized Seizures: Sub-Population Analysis of the Results of a Randomized, Double-Blind, Placebo-Controlled Trial
Abstract 1.267, Saturday, December 4, Noon - 2:00 pm, Hall A, Street Level
Important safety information about Vimpat® in the U.S.
AEDs increase the risk of suicidal behavior and ideation. Patients taking Vimpat® should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
Vimpat® oral solution contains aspartame, a source of phenylalanine. A 200 mg dose of Vimpat® oral solution (equivalent to 20mL) contains 0.32 mg of phenylalanine. Patients should be advised that Vimpat® 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® should be gradually withdrawn to minimize the potential of increased seizure frequency. Multiorgan hypersensitivity reactions have been reported with antiepileptic drugs. If this reaction is suspected, treatment with Vimpat® should be discontinued.
The most common adverse reactions occurring in greater than or equal to 10 percent of Vimpat®-treated patients, and greater than placebo, were dizziness, headache, nausea, and diplopia.
Dosage adjustments are recommended for patients with mild or moderate hepatic impairment or severe renal impairment. Use in severe hepatic impairment patients is not recommended.
Vimpat® is a Schedule V controlled substance.
Please see full prescribing information at http://www.vimpat.com/pdfs/PI.pdf.
(Accessed 28th May 2010)
Vimpat® is a registered trademark under license from Harris FRC Corporation.
Keppra XR® Important Safety Information
Keppra XR® extended-release tablets are indicated as adjunctive therapy in the treatment of POS in patients 16 years of age and older with epilepsy.
Keppra XR® causes somnolence, dizziness, and behavioral abnormalities. The most common adverse reactions observed with Keppra XR® in combination with other AEDs were somnolence and irritability.
The adverse reactions that may be seen in patients receiving Keppra XR® are expected to be similar to those seen in patients receiving immediate-release Keppra® (levetiracetam) tablets.
Keppra® 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 POS, the most common adverse reactions observed with Keppra® in combination with other AEDs were somnolence, asthenia, infection, and dizziness.
Keppra XR® 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® be used instead of Keppra XR®.
For full prescribing information, please see www.KeppraXR.com.
Epilepsy is a chronic neurological disorder affecting approximately three million people in the U.S.—making it as common as breast cancer. Anyone can develop epilepsy; it occurs across all ages, races and genders. Uncontrolled seizures and medication side effects pose challenges to independent living, learning and employment, so the goal of epilepsy treatment is seizure freedom with minimal side effects. However, only half of people diagnosed will achieve seizure freedom with the first medication they try and more than one million people in the U.S. continue to experience seizures despite trying two or more antiepileptic drugs. New medications and treatments give hope to those living with uncontrolled seizures.
Senior Manager, Communications & PR, CNS, UCB, Inc.
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 8,000 people in about 40 countries, the company generated revenue of EUR 3.1 billion in 2009. 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.