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The US Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for the use of lacosamide in the treatment of adults with diabetic neuropathic pain.
The announcement from Belgian biopharmaceutical firm UCB said that the application related 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.”
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 characterised by a stabbing or burning sensation in the legs, feet, and/or hands.
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).
In placebo-controlled clinical trials of more than 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.