Navigation Links
Data Presented at AAN Support Potential for Adjunctive use of Intravenous Lacosamide as Short-Term Replacement for Oral Treatment in Partial Epilepsy
Date:4/18/2008

SMYRNA, Ga., April 18 /PRNewswire/ -- Data presented today at a platform session of the 60th Annual Meeting of the American Academy of Neurology (AAN) in Chicago support the potential for adjunctive use of intravenous lacosamide 200-600 mg/day using infusion durations as fast as 10 minutes for short term replacement of oral lacosamide in adult patients with partial onset seizures.

Regulatory filings for lacosamide oral tablet, oral syrup and intravenous formulation are currently under review by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) for use as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy.

"When patients are temporarily hospitalized or undergo surgical procedures making it difficult to swallow, they may not be able to take their oral antiepileptic drug. In these circumstances, and in order to maintain seizure control, a short-term, alternative administration of their antiepileptic medication is desirable," said Gregory Krauss, MD, Department of Neurology, Johns Hopkins Epilepsy Center, Baltimore. "In this study, short-term intravenous therapy with lacosamide was well tolerated when substituted for oral lacosamide treatment in patients with certain epilepsy types."

The study was a multi-center, multi-national, open-label trial of 160 patients who were receiving oral lacosamide for at least eight weeks. For the last two weeks of the trial, these patients were on a stable twice daily dosing regimen of lacosamide (200-800 mg/day), as well as concomitant antiepileptic drugs with or without vagus nerve stimulation. During the treatment period (two to five days), oral lacosamide was replaced with intravenous lacosamide, infused at a rate of 10, 15 and 30 minutes.

Intravenous lacosamide was generally well-tolerated and the frequency of adverse events did not increase with more days of exposure or shorter infusion durations. The incidence of adverse events was comparable across all infusion durations (10-, 15- and 30-minute infusions), with headache (5%, 7%, 8%) and dizziness (5%, 6%, 8%) being the most commonly reported. Plasma concentrations were proportional to the actual daily dose given and similar across all infusion duration groups. Intravenous lacosamide was also locally well-tolerated with no serious infusion site reactions. In this study, intravenous lacosamide was administered directly via injection, with no diluent required.

These results support data from an earlier multi-center, double-blind, randomized, inpatient trial that evaluated intravenous lacosamide (200-600 mg/day) as replacement for oral lacosamide in patients with partial onset seizures. In that double-blind trial, intravenous lacosamide showed a similar profile to oral lacosamide when administered as 30- or 60-minute twice daily infusions. The data presented at AAN demonstrated that intravenous lacosamide was also generally well-tolerated at shorter infusion durations.

Intravenous lacosamide was developed as an alternative for patients who temporarily cannot receive oral therapy. Doses of intravenous lacosamide are equivalent to the oral form of the drug and do not require conversion.

About lacosamide: Lacosamide has a dual mode of action and is the first agent of its kind to be clinically studied for the treatment of epilepsy. It selectively enhances slow inactivation of sodium channels and interacts with the neuroplasticity-relevant target-collapsin-response mediator protein-2 (CRMP-2). Lacosamide is also being investigated for its potential effect in reducing diabetic neuropathic pain.

Lacosamide-oral tablet, oral syrup and intravenous formulation-has been filed with the U.S. FDA and the EMEA for use as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy and is currently under review.

Applications for marketing authorization for lacosamide in epilepsy are 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 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% and greater than placebo) reported in these trials included dizziness, headache, nausea and diplopia.

Further information

Andrea Levin

Public Relations Manager, CNS, UCB

T 770.970.8352

M 404.483.7329

Andrea.levin@ucb-group.com

Sarah Handza

Cooney/Waters Group

T 212.886.2206

M 646.236.1458

Shandza@cooneywaters.com

About UCB

UCB (Euronext: UCB) is a global leader in the biopharmaceutical industry dedicated to the research, development and commercialization of innovative pharmaceutical and biotechnology products in the fields of central nervous system disorders, allergy/respiratory diseases, immune and inflammatory disorders and oncology. Employing approximately 12,000 people in more than 40 countries, UCB achieved revenue of 3.6 billion euro in 2007. UCB is listed on the Euronext Brussels Exchange. Worldwide headquarters is located in Brussels, Belgium; U.S. headquarters is located in Atlanta, Georgia. For more information about UCB, visit http://www.ucb-group.com.


'/>"/>
SOURCE UCB
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Data Presented at the American Academy of Neurology Show XP13512/GSK1838262 Significantly Improved Symptoms of Moderate-to-Severe Primary Restless Legs Syndrome
2. Data Presented at AAN Show That Lacosamide Significantly Reduced Pain and was Generally Well Tolerated in Patients With Diabetic Neuropathic Pain
3. Preclinical Study Presented at AACR Annual Meeting Shows Peregrines Anti-PS Immunocytokines Can Generate Protective Immune Responses in a Highly Aggressive Breast Cancer Model
4. Data Presented at AACR Annual Meeting Shows Bavituximab Equivalent Plus Docetaxel Reduces Tumor Growth By Up to 95% and Halts Metastasis in a Model of Hormone-Refractory Prostate Cancer
5. Preclinical Study Presented at AACR Annual Meeting Shows Broad Anti-Cancer Potential of Peregrines anti-PS Vascular Targeting Antibodies
6. Additive Anti-Tumor Activity of NKTR-102 in Combination With Bevacizumab Highlighted in Positive Preclinical Data Presented at AACR Meeting
7. PG500 Series Presented at the AACR Annual Meeting in San Diego
8. Research Presented at ISHLT Shows Promise of Addressing Critical Organ Shortage and Better Organ Preservation
9. Poniard Pharmaceuticals Announces Presentation of Clinical Data From Picoplatin Phase 2 Small Cell Lung Cancer Trial to be Presented at 1st IASLC-ESMO European Lung Cancer Conference
10. Data From Ortho Biotech-Sponsored Studies to be Presented at National Kidney Foundation 2008 Spring Clinical Meetings
11. Senescos Preclinical Pancreatic Islet Data to be Presented at Upcoming Conferences
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/10/2017)... -- NDS received FDA 510(k) clearance in May 2017 for its highly ... designed for endoscopy environments. An innovative secondary monitor solution, ZeroWire ... support the improvement of patient outcomes, procedural efficiency, and the lowering ... ... ...
(Date:10/4/2017)... 4, 2017  South Korean-based healthcare product Development Company ... "cprCUBE" on Kickstarter. The device will educate the user ... with better efficiency compared to the dated and pricey ... on efficacy of the compression for a more informed ... goal to raise $5,000. ...
(Date:10/2/2017)... 2017  Eli Lilly and Company (NYSE: ... third quarter of 2017 on Tuesday, October 24, 2017. ... day with the investment community and media to further ... call will begin at 9 a.m. Eastern time. Investors, ... webcast of the conference call through a link that ...
Breaking Medicine Technology:
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Apple ... care services, staged a mock evacuation of the facility as part of a disaster ... Fire Department, Echo Hose EMS and Shelton City Emergency Manager, as well as the ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Global Healthcare Management’s ... Alexandria Park in Milford, NJ. This free event, sponsored by Global Healthcare Management’s ... The fun run is geared towards children of all ages; it is a ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the ... danger possible to save lost souls in the Philippines. “The Journey: From the Mountains ... a dedicated teacher of the Bible. She has taught all ages and currently teaches ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest and ... plans to open a flagship location in Covington, LA at 401 N. U.S. Highway ... store next to Office Depot in the Holiday Square shopping center. Its location allows ...
(Date:10/12/2017)... ... 2017 , ... Asante, a nationally recognized health system in ... existing home health joint venture through an agreement, effective October 1, 2017, to ... home health company with Asante, delivering clinically integrated care, for the past eight ...
Breaking Medicine News(10 mins):