Navigation Links
UCB Announces FDA Filing for lacosamide in the Treatment of Partial Onset Seizures in Adults with Epilepsy
Date:11/29/2007

U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for the use of lacosamide as adjunctive therapy in

the treatment of partial onset seizures in adults with epilepsy.

ATLANTA, Nov. 29 /PRNewswire/ -- UCB announced today that the U.S. Food and Drug Administration has accepted for filing the New Drug Application (NDA) for the use of lacosamide as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. The application includes three lacosamide formulations -- tablets, syrup and an intravenous injection. The proposed trade name for lacosamide is Vimpat(TM).

"This filing is another step in support of UCB's epilepsy franchise and its long-term commitment to advancing treatment options for patients with epilepsy," said Iris Loew-Friedrich, MD, PhD, Global Head of Development, UCB.

The NDA for lacosamide in epilepsy is supported by data from three clinical trials with a total of approximately 1,300 adults with uncontrolled partial onset seizures, despite taking one to three antiepileptic drugs (AEDs). In these studies, significantly greater 50% responder rates and reductions in median seizure frequency were seen versus placebo. The most common adverse events of lacosamide (greater than or equal to 10%) reported in these trials included dizziness, headache, nausea and diplopia.

A similar filing made to the European Medicines Agency (EMEA) earlier this year for the use of lacosamide as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy, was accepted and is currently under review.

About Epilepsy: Epilepsy is a chronic neurological disorder affecting 40 million people worldwide including 2.5 million people in the US. 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 and effective classification guides treatment and prognosis. Between 70-80% of individuals are successfully treated with one of the more than 20 antiepileptic drugs now available. However, 20-30% of patients have either intractable or uncontrolled seizures or significant adverse side effects secondary to medication highlighting the ongoing need for the development of new antiepileptic drugs.

About Lacosamide: Lacosamide has a novel and dual mode of action. It selectively enhances slow inactivation of sodium channels and interacts with the neuroplasticity-relevant target-collapsin-response mediator protein-2 (CRMP-2).

About UCB

UCB, Brussels, Belgium (http://www.ucb-group.com) is a global leader in the biopharmaceutical industry dedicated to the research, development and commercialisation of innovative pharmaceutical and biotechnology products in the fields of central nervous system disorders, allergy/respiratory diseases, immune and inflammatory disorders and oncology. UCB focuses on securing a leading position in severe disease categories. Employing more than 10,000 people in over 40 countries, UCB achieved revenue of 3.5 billion euro in 2006 on a pro forma basis. UCB S.A. is listed on the Euronext Brussels Exchange and, through its affiliate, owns approx. 89% of the shares of SCHWARZ PHARMA AG. SCHWARZ PHARMA (Monheim, Germany) is a member of the UCB Group.

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, Inc
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. HHS Announces $75 Million in Supplemental Funding to States for Pandemic Flu Preparedness
2. CRC Health Group Announces Acquisition of Bayside Marin Recovery Center, San Rafael
3. UHW Announces: Antelope Valley Hospital Caregivers and Board Vote to Ratify First Union Contract With SEIU UHW-West
4. HEI, Inc. Announces Sale of RFID Division Assets
5. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Zyloprim(R)
6. Mettler-Toledo International Inc. Announces Webcast of Presentation at Thomas Weisel Partners 2007 Healthcare Conference
7. Z Trim Announces Revocation of Gregory Halpern Severence Agreement
8. Brooke Franchise Corporation Announces Selected July Results
9. Manor Care, Inc. Announces Record Date for Special Stockholder Meeting
10. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Adipex-P(R)
11. Planet Technologies Announces Agreement to Acquire Antigen Laboratories
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... (PRWEB) , ... June 27, 2016 , ... Quality metrics ... yet in many ways they remain in the eye of the beholder, according to ... a publication of The American Journal of Managed Care. For the full issue, ...
(Date:6/26/2016)... ... ... legally blind and certified personal trainer is helping to develop a weight loss fitness plan ... fix the two major problems leading the fitness industry today:, , ... They don’t eliminate all the reasons people quit their exercise program ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... The temporary closing of Bruton Memorial Library ... City Observer , brings up a new, often overlooked aspect of head lice: the parasite’s ... for fumigation is not a common occurrence, but a necessary one in the event that ...
(Date:6/25/2016)... ... June 25, 2016 , ... ... non-athletes recover from injury. Recently, he has implemented orthobiologic procedures as a method ... —Johnson is one of the first doctors to perform the treatment. Orthobiologics are ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic events may suffer ... unhealthy avenues, such as drug or alcohol abuse, as a coping mechanism. To avoid ... healthy coping following a traumatic event. , Trauma sufferers tend to feel a range ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... , June 24, 2016 Research and ... Market for Companion Diagnostic Tests" report to their offering. ... for Companion Diagnostics The World Market for ... personalized medicine diagnostics. Market analysis in the report includes the ... Market (In Vitro Diagnostic Kits) by Region (N. America, EU, ...
(Date:6/24/2016)... , Belgium , June 24, ... VNRX), today announced the appointment of Dr. ... Directors as a Non-Executive Director, effective June 23, ... Audit, Compensation and Nominations and Governance Committees.  As ... Futcher will provide independent expertise and strategic counsel ...
(Date:6/23/2016)... June 23, 2016 Research and Markets ... Market - Forecast to 2022" report to their offering. ... method for the patients with kidney failure, it replaces the ... from the patient,s blood and thus the treatment helps to ... chloride in balance. Increasing number of ESRD ...
Breaking Medicine Technology: