New single loading dose option for VIMPAT® (lacosamide) in the European Union allows for rapid initiation of adjunctive treatment in adults with partial onset seizures

Brussels (Belgium), 4th February 2013 – 0850 CEST – UCB today announced that VIMPAT^® (lacosamide) has been approved in the European Union for initiation as a single loading dose (200 mg), followed approximately 12 hours later by a 100 mg twice daily lacosamide maintenance dose regimen. The single loading dose option means that healthcare professionals in the European Union may choose between initiating adjunctive lacosamide treatment for adults with partial onset seizures using the standard dosing regimen, or alternatively using the single loading dose option when warranted._¹

“As a leader in epilepsy, UCB is committed to delivering solutions aimed at improving the lives of people with epilepsy and advancing current standards of care. The single loading dose option is available for all formulations of lacosamide in the European Union and should help to fill an important treatment gap in adjunctive options for patients with partial onset seizures. It allows for the rapid attainment of lacosamide steady state plasma concentration in situations where it is deemed appropriate by the prescribing physician.” said Professor Dr Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President UCB.

“A single loading dose option allows for the rapid initiation of adjunctive lacosamide treatment for partial onset seizures in adults with epilepsy when required,” said Dr. Fountain, Professor of Neurology and Director of the Comprehensive Epilepsy Program at the University of Virginia in Charlottesville, Virginia, USA. “The open-label intravenous study showed that rapid initiation of adjunctive lacosamide treatment was generally well tolerated by patients requiring a loading dose.”

The single loading dose option is approved for all formulations of lacosamide – oral tablets, oral syrup and solution for infusion. A single loading dose should be administered under medical supervision in situations where rapid attainment of lacosamide steady state plasma concentration and therapeutic effect are warranted. Consideration should also be given to a potential increase in incidence of CNS adverse effects such as dizziness. Administration of a single loading dose has not been studied in acute conditions such as status epilepticus.¹

In patients with mild or moderate renal impairment or mild to moderate hepatic impairment, a single loading dose of 200 mg may be considered, but further dose titration should be performed with caution. In patients with severe renal impairment and in patients with end stage renal disease, a maximum maintenance dose of 250 mg/day is recommended. In these patients, the dose titration should be performed with caution. If a single loading dose is indicated, an initial dose of 100 mg followed by a 50 mg twice daily regimen for the first week should be used. The pharmacokinetics of lacosamide has not been evaluated in severely hepatic impaired patients.¹

VIMPAT^® was first launched in the European Union in September 2008, as adjunctive therapy for the treatment of partial onset seizures with or without secondary generalization in adult and adolescent (16-18 years) patients with epilepsy and is available as film-coated tablets, syrup and solution for infusion. VIMPAT^® solution for infusion can be used to initiate lacosamide treatment and is also an alternative for patients when oral administration is temporarily not feasible.¹

The most common adverse reactions occurring in 10 per cent or more of lacosamide-treated patients, and greater than placebo, were dizziness, headache, nausea, and diplopia.¹ Incidence of CNS adverse reactions such as dizziness may be higher after a loading dose.¹ Additional important safety information for lacosamide is available below.¹

About Vimpat^®

Important safety information about Vimpat® in the EU and EEA

Vimpat® (lacosamide) is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalization in adult and adolescent (16-18 years) patients with epilepsy. Vimpat® therapy can be initiated with either oral or IV administration. A loading dose may be initiated in patients in situations when the physician determines that rapid attainment of lacosamide steady state plasma concentration and therapeutic effect is warranted. It should be administered under medical supervision with consideration of the potential for increased incidence of CNS adverse reactions. Administration of a loading dose has not been studied in acute conditions such as status epilepticus. Contraindications: Hypersensitivity to the active substance or any of the excipients; known second- or third-degree atrioventricular (AV) block. Special warnings and precautions for use: Treatment with Vimpat® has been associated with dizziness which could increase the occurrence of accidental injury or falls. Therefore, patients should be advised to exercise caution until they are familiar with the potential effects of the medicine. Prolongations in PR interval with Vimpat® have been observed in clinical studies. Cases with second- and third-degree AV block associated with Vimpat® treatment have been reported in post-marketing experience. Vimpat® should be used with caution in patients with known conduction problems or severe cardiac disease such as a history of myocardial infarction or heart failure. Caution should especially be exerted when treating elderly patients as they may be at an increased risk of cardiac disorders or when Vimpat® is used in combination with products known to be associated with PR prolongation. In the placebo-controlled trials of Vimpat® in epilepsy patients, atrial fibrillation or flutter were not reported; however both have been reported in open-label epilepsy trials and in post-marketing experience. Patients should be made aware of the symptoms of second-degree or higher AV block (e.g. slow or irregular pulse, feeling of lightheaded and fainting) and of the symptoms of atrial fibrillation and flutter (e.g. palpitations, rapid or irregular pulse, shortness of breath). Patients should be counselled to seek medical advice should any of these symptoms occur. Suicidal ideation and behavior have been reported in patients treated with anti-epileptic agents in several indications. Therefore patients should be monitored for signs of suicidal ideation and behaviors and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behavior emerge. Vimpat® syrup contains sodium methyl parahydroxybenzoate (E219) which may cause allergic reactions (possibly delayed).Patients with rare hereditary problems of fructose intolerance should not take this medicine. The syrup contains aspartame (E951), a source of phenylalanine, which may be harmful for people with phenylketonuria. Vimpat® syrup and the solution for infusion contain sodium, which should be taken into consideration for patients on a controlled sodium diet. Effects on ability to drive and use machines: Vimpat® may have minor to moderate influence on the ability to drive and use machines. Vimpat® treatment has been associated with dizziness or blurred vision. Accordingly patients should be advised not to drive a car or to operate other potentially hazardous machinery until they are familiar with the effects of Vimpat® on their ability to perform such activities. Undesirable effects: The most common adverse reactions (≥10%) are dizziness, headache, diplopia, and nausea. They were usually mild to moderate in intensity. Some were dose-related and could be alleviated by reducing the dose. Incidence and severity of CNS and gastrointestinal (GI) adverse reactions usually decreased over time. Incidence of CNS adverse reactions such as dizziness may be higher after a loading dose. Other common adverse reactions (≥1% - <10%) are depression, confusional state, insomnia, balance disorder, coordination abnormal, memory impairment, cognitive disorder, somnolence, tremor, nystagmus, hypoesthesia, dysarthria, disturbance in attention, vision blurred, vertigo, tinnitus, vomiting, constipation, flatulence, dyspepsia, dry mouth, pruritus, rash, muscle spasms, gait disturbance, asthenia, fatigue, irritability, injection site pain or discomfort (specific to solution for infusion), irritation (specific to solution for infusion), fall, and skin laceration. The use of Vimpat® is associated with dose-related increase in the PR interval. Adverse reactions associated with PR interval prolongation (e.g. atrioventricular block, syncope, bradycardia) may occur. Laboratory abnormalities: Abnormalities in liver function tests have been observed in controlled trials with Vimpat® in adult patients with partial-onset seizures who were taking 1-3 concomitant antiepileptic drugs. Elevations of ALT to ≥3XULN occurred in 0.7% (7/935) of Vimpat® patients and 0% (0/356) of placebo patients. Multiorgan Hypersensitivity Reactions: Multiorgan hypersensitivity reactions have been reported in patients treated with some antiepileptic agents. These reactions are variable in expression but typically present with fever and rash and can be associated with involvement of different organ systems. Potential cases have been reported rarely with Vimpat® and if multiorgan hypersensitivity reaction is suspected, Vimpat® should be discontinued.
Refer to the European Summary of Product Characteristics for other adverse reactions and full prescribing information. Date of revision: 22nd November 2012.

http://ec.europa.eu/health/documents/community-register/html/h470.htm (Accessed December 2012)

References

1. http://ec.europa.eu/health/documents/community-register/html/h470.htm (Accessed December 2012)

For further information
Eimear O Brien, Brand Communications, UCB
T +32.2.559.9271, eimear.obrien@ucb.com

Antje Witte, Investor Relations, UCB
T +32.2.559.9414, antje.witte@ucb.com

France Nivelle, Global Communications, UCB
T +32.2.559.9178, france.nivelle@ucb.com

Laurent Schots, Media Relations, UCB
T +32.2.559.9264, laurent.schots@ucb.com

About UCB
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 8 500 people in about 40 countries, the company generated revenue of EUR 3.2 billion in 2011. UCB is listed on Euronext Brussels (symbol: UCB).

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