More hope for control for Canadian adults with epilepsy
New add-on treatment for partial onset seizures approved by Health Canada
OAKVILLE, ON, Nov. 11 /CNW/ - UCB Canada Inc. announced today that Health Canada has approved Vimpat™ (lacosamide), a new antiepileptic drug (AED). Vimpat™ is indicated for use as adjunctive therapy in the management of partial onset seizures in adult patients 18 years of age and older who are not satisfactorily controlled with conventional therapy.
"Vimpat™ is an innovation in epilepsy therapy and has been shown to work effectively in conjunction with a broad range of existing treatments," says Dr. Fred Andermann, Professor in Neurology and Pediatrics, McGill University, and Epileptologist, Montreal Neurological Institute and Hospital. "Vimpat™ is an important consideration for use by physicians and their adult patients with partial onset seizures who are still uncontrolled despite their current treatment."
Controlling Partial Onset Seizures
Partial onset seizures are one of the most common types of seizures experienced by patients with epilepsy,1 and up to one-third of Canadian patients do not have seizure control.2,3
"After almost a decade, we are thrilled that there is a new treatment for people with epilepsy in Canada," says Gail Dempsey, President, Canadian Epilepsy Alliance. "Lack of seizure control severely impacts independence, productivity, and overall quality of life for Canadians living with epilepsy. These individuals and their families deserve better, and we're so pleased that patients now have a new option in Vimpat™."
Epilepsy and Quality of Life
Lack of seizure control severely impacts independence, productivity and overall quality of life for Canadians living with epilepsy. The disorder can cause significant challenges, including difficulty finding employment, loss of driving privileges in some Canadian provinces, cognitive decline and memory impairment, and higher mortality rates. People living with epilepsy also live with a significant social stigma associated with seizures. 4
New Way of Targeting Pathways Involved in Seizure Onset
Preclinical studies indicate that Vimpat™ has a novel mode of action. While the precise way in which Vimpat™ exerts its antiepileptic effect in humans is unknown, in preclinical studies Vimpat™ has been shown to modulate sodium channel activity differently compared with other sodium channel blocking AEDs.5,6,7
Sodium channels play a crucial role in regulating the activity of the nervous system to help nerve cells communicate. Sometimes sodium channels become abnormally overactive which may produce a seizure. Vimpat™ is thought to reduce this sodium channel over-activity, which may contribute to the control of seizures.5,6,7,8
Improved Seizure Control When Added to a Wide Range of Antiepileptic Drugs
The approval of Vimpat™ was based on efficacy and safety data from three multicentre, randomized, placebo-controlled clinical trials with approximately 1,300 people with epilepsy aged 16 and older who had uncontrolled partial-onset seizures. Before adding Vimpat™, patients experienced a median baseline seizure frequency ranging from 10 to 17 seizures per month, despite being on one to three other AEDs. In the trials, patients randomized to Vimpat™ experienced reductions in median seizure frequency and had their seizures reduced by half at rates that were significantly greater than those in placebo groups. The most common adverse events (>10 per cent and greater than placebo) reported in these trials included dizziness, headache, nausea and diplopia.8,9,10,11
Vimpat™ demonstrated efficacy and was generally well-tolerated when combined with a broad range of existing AEDs.10,12,13
About Epilepsy in Canada
Epilepsy is a chronic neurological disorder that affects approximately 300,000 people in Canada14 and 50 million people worldwide.15 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. This highlights the ongoing need for the development of new AEDs.
About UCB Canada Inc.
UCB Canada Inc. was officially incorporated in 2006 with the objective of bringing new-generation therapies to the Canadian market for auto-immune and central nervous system diseases. As a patient-focused organization, the company is dedicated to bringing new and innovative programs to patients, and to the specialists who treat them, to help improve the lives of people living with severe diseases.
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 8 000 people in about 40 countries, the company generated revenue of EUR 3.1 billion in 2009. UCB is listed on Euronext Brussels (symbol: UCB).
References:
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4 Lowenstein. Harrison's Principles of Internal Medicine. 2008.
5 Ben-Menachem,E lacosamide: an investigational drug for adjunctive treatment of partial-onset seizures. Drugs of Today. 2007; 43. Available at www.prous.com/journals
6 Beyreuther K, Joachim, Freitag, Cara Heers, Niels Krebsfanger, Ute Scharfenecker and Thomas Stohr. Lacosamide: A Review of Preclinical Properties. CNS Drug Reviews. 13: 1; 21;42 2007
7 Heers, C., Beyreuther, B., Freitag, J., Lees, G., Errington, A., Stohr, T. Lacosamide selectively enhances sodium channel slow inactivation. Poster Presentation, 11th EFNS, Brussels, 25-28, August 2007
8 VIMPAT™ Product Monograph, September 2010
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11 Halasz et al. Epilepsia. 2009; 50 (3) 443-453.
12 Halász P, Kälviäinen R, Mazurkiewicz-Beldzinska M, Rosenow F, Doty P, Sullivan P and the SP755 Study Group. Lacosamide: Efficacy and Safety as Oral Adjunctive Therapy in Adults with Partial Seizures. Poster Presentation, 11th EFNS, Brussels 25-28, August 2007
13 Ben-Menachem E, Biton V, Jatuzis D, Abou-Khalil B, Rudd GD and the SP667 Study Group. Efficacy and Safety of Adjunctive Oral Lacosamide for the Treatment of Partial Onset Seizures in Patients with Epilepsy as Oral Adjunctive Therapy in Adults with Partial Seizures. Poster Presentation, 11th EFNS, Brussels 25-28 August 2007
14 General Information. The Canadian League Against Epilepsy website. Available at http://www.clae.org/html/en/general_information.html. Accessed November 9, 2010.
15 Epilepsy Atlas. WHO website. Available at www.who.int/mental_health/neurology/Epilepsy_atlas_r1.pdf. Accessed November 9, 2010.
For further information:
Dita Kuhtey, Cohn & Wolfe
416-924-5700 ext. 4032
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