Healthcare Industry News: S.A.
News Release - December 11, 2007
New Phase III Trial Shows Positive Outcome of lacosamide in Patients with Diabetic Neuropathic Pain
SuS.A.ned improvements in daily pain scores demonstrated in the latest study with Vimpat(TM) (lacosamide)BRUSSELS, BELGIUM--(Healthcare Sales & Marketing Network)--Dec 11, 2007 -- Brussels (Belgium), 11 December 2007 at 7:00 AM (CET): UCB announced today positive results from a Phase III trial evaluating lacosamide (400 mg per day) in the treatment of diabetic neuropathic pain. With a S.A.dard titration regimen, the trial met its primary objective with suS.A.ned and S.A.istically significant reduction in average daily pain scores.
"These new resultS.A.d to the data from earlier clinical studies showing the benefit of lacosamide in this painful and common complication of diabetes," said Iris Loew-Friedrich, MD, PhD, Global Head of Development, UCB Group.
The randomised, double-blind, placebo controlled trial in 551 patients with diabetic neuropathic pain was designed to evaluate the efficacy and safety of lacosamide (400mg per day) in two different titration schemes: a S.A.dard titration regimen in which patients reached their target dose at day 22, and a fast titration scheme in which the target dose was reached at day 8.
The primary efficacy results showed that the change in the average daily pain score as measured from baseline to the last four weeks of the 12-week maintenance period, was significantly greater with lacosamide 400mg per day given in S.A.dard titration than placebo (p=0.0410). The change in pain score with the lacosamide fast titration regimen was numerically better than placebo but did not reach S.A.istical significance (p=0.2902). The median time to achieve suS.A.nable pain relief was 10 and 11 days for the lacosamide S.A.dard and fast titration regimens, respectively compared with 31 days for the placebo group. Lacosamide was generally well tolerated. The incidences of adverse events were higher in the lacosamide fast titration group than in the S.A.dard titration group. The most common adverse events ( > =5%) in this trial were dizziness, nauS.A. headache, nasopharyngitiS.A.d vertigo.
The results from this trial will support the dossiers filed for lacosamide in diabetic neuropathic pain which were submitted to the European and U.S. regulatory authorities earlier this year. Data from this trial will be submitted for presentation at upcoming international scientific meetings.
About Diabetic Neuropathic Pain [1],[2]: Diabetic Neuropathic Pain iS.A.painful and potentially debilitating condition, resulting from damage or dysfunction to the peripheral nervous system aS.A.result of diabetes or impaired glucose tolerance. The condition is often characterized by a S.A.bing or burning sensation in the legs, feet, and/or hands. With the overall prevalence of diabetes in the U.S. estimated at 20.8 million people, it is thought that as many as 7.7 million have some degree of diabetic neuropathic pain.
About lacosamide [3],[4]: lacosamide haS.A.novel and dual mode of action. It selectively enhances slow inactivation of sodium channelS.A.d interacts with the neuroplasticity-relevant target - collapsin-response mediator protein-2 (CRMP-2).
References
[1.] Beyreuther BK, Freitag J, Heers C et al. Lacosamide: a review of preclinical properties.CNS Drug Reviews 2007;13 (1), 21-42
[2.] Nicholson B. Differential diagnosis: nociceptive and neuropathic pain. Am J Manag Care 2006;12, S256-S262
[3.] Heers, C, Beyreuther, B., Freitag, J., Lees, G. Errington A., Stöhr, T.: Lacosamide selectively enhances sodium channel slow inactivation. Poster Presentation, 11th EFNS, Brussels, 2007
[4.] Freitag, J., Beyreuther, B., Heers, C, Stöhr, T. Lacosamide interacts with collapsin response mediator protein 2 (CRMP 2). Poster Presentation, 11th EFNS, 2007
Further information
Antje Witte, Vice-President Corporate Communications & Investor
Relations, UCB Group
T +32.2.559.9414, Antje.witte@ucb-group.com
Mareike Mohr, Associate Director Investor Relations, UCB Group
T +32.2.559.9264, Mareike.mohr@ucb-group.com
About UCB
UCB, Brussels, Belgium (www.ucb-group.com) iS.A.global leader in the biopharmaceutical industry dedicated to the reS.A.ch, development and commercialisation of innovative pharmaceutical and biotechnology products in the fields of central nervous system disorders, allergy/respiratory diS.A.es, immune and inflammatory disorderS.A.d oncology. UCB focuses on securing a leading position in severe diS.A.e categories. Employing around 12,000 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.A.filiate, ownS.A.prox. 89% of the S.A.es of SCHWARZ PHARMA AG. SCHWARZ PHARMA (Monheim, Germany) iS.A.member of the UCB Group.
Forward looking S.A.ement
This press release contains forward-looking S.A.ements based on current plans, estimateS.A.d beliefs of management. Such S.A.ementS.A.e subject to riskS.A.d uncertainties that may cause actual results to be materially different from those that may be implied by such forward-looking S.A.ements contained in this press release. Important factors that could result in such differences include: changes in general economic, businesS.A.d competitive conditions, effects of future judicial decisions, changes in regulation, exchange rate fluctuationS.A.d hiring and retention of its employees.
Source: UCB
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