New Oral Solution Formulation of Antiepileptic Drug Vimpat® (lacosamide) (C-V)

ATLANTA, June 14 /PRNewswire/ -- UCB today announced the availability of an oral solution formulation of Vimpat® (lacosamide) C-V, an antiepileptic drug (AED) for add-on treatment of partial-onset seizures in people with epilepsy age 17 years and older. Vimpat 10 mg/mL solution is now available in U.S. pharmacies.

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Vimpat is now conveniently available in three formulations: oral tablets, oral solution and IV injection, ensuring that patients can maintain consistent Vimpat treatment in any clinical setting.  Vimpat injection is available as an alternative for patients when oral administration is temporarily not feasible.  Vimpat therapy can be initiated with either oral or IV administration, and patients can be converted between formulations -- with equivalent dosing -- without titration.

"Having Vimpat available as an oral solution is very good news," said Ilo E. Leppik, MD, Director, Epilepsy Research and Education Program, University of Minnesota.  "There are many people for whom swallowing pills is difficult and the oral solution, which can be substituted milligram for milligram to the oral tablet, will be helpful to adults with swallowing difficulties. This will be particularly useful for elderly in nursing homes who may have gastric tubes in place."

"Bringing Vimpat to market in a third formulation spotlights UCB's commitment to providing a wide range of treatment options to people living with epilepsy," said James Zackheim, Ph.D., CNS Medical Director at UCB.  "Long-term efficacy and safety data, and more than 50,000 global patient exposures, further strengthens Vimpat's role as an add-on therapy for the treatment of partial-onset seizures in adults."  

In pivotal studies, 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.

About Vimpat Oral Solution

Vimpat oral solution 10 mg/mL is a clear, colorless to yellow or yellow-brown, strawberry-flavored liquid.  It will be supplied in 465 mL PET bottles (NDC 0131-5410-70).

Vimpat oral solution does not require refrigeration and should be stored at controlled room temperature (68 degrees to 77 degrees F).

Vimpat oral solution should be administered with a calibrated measuring device. A household teaspoon or tablespoon is not an adequate measuring device. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

Vimpat oral solution contains aspartame, a source of phenylalanine. A 200 mg dose of Vimpat oral solution (equivalent to 20 mL) contains 0.32 mg of phenylalanine.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

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.

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.

For full prescribing information on Vimpat, visit http://www.vimpat.com/prescribing-information.aspx, and for more information on Vimpat, visit Vimpat.com or contact UCB at (800) 477-7877.

Vimpat® is a registered trademark under license from Harris FRC Corporation.

About Epilepsy

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.

About UCB

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 9,000 people in over 40 countries, UCB produced revenue of EUR 3.1 billion in 2009. UCB is listed on Euronext Brussels (symbol: UCB). U.S. headquarters is located in Atlanta.

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.

SOURCE UCB

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