UCB said a phase III trial evaluating its drug lacosamide (400 mg per day) for the treatment diabetic neuropathic pain showed positive results. With a standard titration regimen, the trial met its primary objective with sustained and statistically significant reduction in average daily pain scores.
"These new results add to the data from earlier clinical studies showing the benefit of lacosamide in this painful and common complication of diabetes," said Iris Loew-Friedrich, MD, PhD, Global Head of Development, UCB Group.
The randomised, double-blind, placebo controlled trial in 551 patients with diabetic neuropathic pain was designed to evaluate the efficacy and safety of lacosamide (400mg per day) in two different titration schemes: a standard titration regimen in which patients reached their target dose at day 22, and a fast titration scheme in which the target dose was reached at day 8.
The primary efficacy results showed that the change in the average daily pain score as measured from baseline to the last four weeks of the 12-week maintenance period, was significantly greater with lacosamide 400mg per day given in standard titration than placebo. The change in pain score with the lacosamide fast titration regimen was numerically better than placebo but did not reach statistical significance. The median time to achieve sustainable pain relief was 10 and 11 days for the lacosamide standard and fast titration regimens, respectively compared with 31 days for the placebo group. Lacosamide was generally well tolerated. The incidences of adverse events were higher in the lacosamide fast titration group than in the standard titration group. The most common adverse events in this trial were dizziness, nausea, headache, nasopharyngitis and vertigo.
The results from the trial will support the dossiers filed for lacosamide in diabetic neuropathic pain which were submitted to the European and US regulatory authorities earlier this year. Data from this trial will be submitted for presentation at upcoming international scientific meetings.
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.