ATLANTA, Nov. 29 /PRNewswire/ -- UCB announced today that the U.S. Food
and 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, whose proposed trade name is Vimpat(TM).
"The fact that a high proportion of patients with diabetic neuropathic
pain do not achieve satisfactory pain relief with current management
options is a powerful stimulus to research and develop new therapies," said
Iris Loew- Friedrich, MD, PhD, Global Head of Development, UCB. "The FDA
acceptance for review means that a full assessment will be carried out on
lacosamide's potential to provide sustained pain relief in patients with
moderate to severe diabetic neuropathic pain."
In placebo-controlled clinical trials of over 800 people with diabetic
neuropathic pain, significant and sustained reductions in pain scores were
seen versus placebo. The pain relief achieved with lacosamide was
associated with reduced interference with sleep and general activities. The
most common adverse events of lacosamide (greater than or equal to 10%)
reported in these trials included dizziness, nausea, tremor and headache.
A similar filing made to the European Medicines Agency (EMEA) earlier
this year 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 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
stabbing 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: 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
UCB, Brussels, Belgium (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
SOURCE UCB, Inc.