UCB Announces FDA Filing for lacosamide in the Treatment of Diabetic Neuropathic...
UCB Announces FDA Filing for lacosamide in the Treatment of DiabeticNeuropathic PainU.S. Food and Drug Administration (FDA) has accepted for filing the New DrugApplication (NDA) for the use of lacosamide in the treatment of adults withdiabetic neuropathic pain.ATLANTA, Nov. 29 /PRNewswire/ -- UCB announced today that the U.S. Foodand Drug Administration (FDA) has accepted for filing the New Drug Application
(NDA) for the use of lacosamide in the treatment of diabetic neuropathic pain.The application relates to the tablet formulation of lacosamide, whoseproposed trade name is Vimpat(TM).
"The fact that a high proportion of patients with diabetic neuropathicpain do not achieve satisfactory pain relief with current management optionsis a powerful stimulus to research and develop new therapies," said Iris Loew-Friedrich, MD, PhD, Global Head of Development, UCB. "The FDA acceptance forreview means that a full assessment will be carried out on lacosamide'spotential to provide sustained pain relief in patients with moderate to severediabetic neuropathic pain."
In placebo-controlled clinical trials of over 800 people with diabeticneuropathic pain, significant and sustained reductions in pain scores wereseen versus placebo. The pain relief achieved with lacosamide was associatedwith reduced interference with sleep and general activities. The most commonadverse events of lacosamide (greater than or equal to 10%) reported in thesetrials included dizziness, nausea, tremor and headache.
A similar filing made to the European Medicines Agency (EMEA) earlier thisyear for the use of lacosamide in the treatment of diabetic neuropathic pain,was also accepted and is currently under review.
About Diabetic Neuropathic Pain: Diabetic Neuropathic Pain is a painfuland potentially debilitating condition, resulting from damage or dysfunctionto the peripheral nervous system as a result of diabetes or impaired glucosetolerance. The condition is often characterized by a stabbing or burningsensation in the legs, feet, and/or hands. With the overall prevalence ofdiabetes in the U.S. estimated at 20.8 million people, it is thought that asmany as 7.7 million have some degree of diabetic neuropathic pain.
About Lacosamide: Lacosamide has a novel and dual mode of action. Itselectively enhances slow inactivation of sodium channels and interacts withthe neuroplasticity-relevant target-collapsin-response mediator protein-2
(CRMP-2).
About UCB
UCB, Brussels, Belgium (www.ucb-group.com) is a global leader in thebiopharmaceutical industry dedicated to the research, development andcommercialisation of innovative pharmaceutical and biotechnology products inthe fields of central nervous system disorders, allergy/respiratory diseases,immune and inflammatory disorders and oncology. UCB focuses on securing aleading position in severe disease categories. Employing more than 10,000people in over 40 countries, UCB achieved revenue of 3.5 billion euro in 2006on a pro forma basis. UCB S.A. is listed on the Euronext Brussels Exchangeand, through its affiliate, owns approx. 89% of the shares of SCHWARZ PHARMAAG. SCHWARZ PHARMA (Monheim, Germany) is a member of the UCB Group.
Forward looking statement
This press release contains forward-looking statements based on currentplans, estimates and beliefs of management. Such statements are subject torisks and uncertainties that may cause actual results to be materiallydifferent from those that may be implied by such forward-looking statementscontained in this press release. Important factors that could result in suchdifferences include: changes in general economic, business and competitiveconditions, effects of future judicial decisions, changes in regulation,exchange rate fluctuations and hiring and retention of its employees.SOURCE UCB, Inc.Andrea Levin, Public Relations Manager of UCB, Inc., +1-770-970-8352, mobile:+1-404-483-7329, Andrea.levin@ucb-group.com; or Lindsey Smith of ChandlerChicco Agency, +1-212-229-8481, Mobile, +1-914-720- 4258, lsmith@ccapr.com
