In placebo-controlled clinical trials of over 800 people with diabetic neuropathic pain, significant and sustained reductions in pain scores were seen versus placebo.
A similar filing made to the European Medicines Agency in 2007 for the use of lacosamide in the treatment of diabetic neuropathic pain, was also accepted and is currently under review.
Iris Loew-Friedrich, global head of development, UCB, said: “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.”