UCB has announced that the 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
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
bDiabetic 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 protein-2
(CRMP-2).
About UCB
UCB, Brussels, Belgium, 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.
For more information, visit http://www.ucb-group.com or call
770/970.8352.
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