UCB has announced that US Food and Drug Administration (FDA) accepted 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.
"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 (>=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.
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 US estimated at 20.8 million people, it is thought that as many as 7.7 million have some degree of diabetic neuropathic pain.
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).
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.