SMYRNA, Ga., April 16 /PRNewswire/ -- UCB presented efficacy and safety results from pooled analyses of Phase II and III double-blind, randomized, placebo-controlled clinical trials investigating lacosamide for the treatment of diabetic neuropathic pain. These data, which were presented at the 60th Annual Meeting of the American Academy of Neurology (AAN) in Chicago, showed that lacosamide significantly reduced pain in patients with diabetic neuropathic pain and was generally well-tolerated.
Lacosamide is currently under review with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) for the treatment of diabetic neuropathic pain and as adjunctive therapy for the treatment of partial onset seizures in adults with epilepsy.
"Neuropathy can be a painful and potentially debilitating complication of diabetes, and there is still a need for new treatment options," said Aziz Shaibani, M.D., F.A.C.P., lacosamide clinical investigator and director of the Nerve and Muscle Center of Texas in Houston. "These data showed that lacosamide reduced pain in patients with diabetic neuropathic pain and was generally well-tolerated."
Pooled Efficacy Analysis
Primary efficacy was evaluated among patients treated with 400 mg/day of lacosamide by examining the change in average daily pain score, from baseline to the last four weeks of maintenance in three Phase III, fixed-dose trials (SP742, SP743, SP768) and from baseline through the entire maintenance period in one Phase II, flexible-dose trial (SP614). The pain score was based on an 11-point Likert Scale ranging from zero (no pain) to 10 (worst possible pain).
The mean reduction in pain score reached the level of statistical significance in SP614, SP742 and SP768 (p=0.039, 0.01 and 0.0507, respectively). Significance was not reached for the primary endpoint in SP743, likely due to a strong placebo effect at the final visit.
Additionally, a meta-analysis of all Phase III, fixed-dose trials showed a significant mean reduction in pain score of -2.14 for the lacosamide group compared with -1.57 for placebo (p=0.0006). Results on the secondary outcome of pain reduction from baseline through the entire maintenance period were also statistically significant for all fixed-dose trials (p=<.001).
Pooled Safety Analysis
In these trials, the overall percentage of patients who discontinued treatment due to adverse events was similar between the placebo group and the lacosamide 200 and 400 mg/day groups (24.7 percent, 29.9 percent and 32.9 percent, respectively). The percentage was higher (55.4 percent) in the group receiving 600 mg/day of lacosamide.
Overall, treatment emergent adverse events (TEAEs) were reported by a similar percentage of patients in the placebo (72.9 percent) and in the pooled lacosamide groups (76.3 percent). The most frequently reported TEAEs in the pooled lacosamide group, which were greater than placebo, were dizziness (16.3 vs. 5.2 percent), nausea (10.3 vs. 6.2 percent), fatigue (6.7 vs. 4.1 percent) and tremor (6.5 vs. 1.0 percent). In addition, lacosamide had no effect on body weight in these trials.
Lacosamide has a dual mode of action and is the first agent of its kind to be clinically studied for the treatment of diabetic neuropathic pain. It selectively enhances slow inactivation of sodium channels and interacts with the collapsin-response mediator protein-2 (CRMP-2). Lacosamide is also being investigated for its potential as adjunctive therapy to treat partial onset seizures in adults with epilepsy.
Lacosamide oral tablet has been filed with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) for the treatment of diabetic neuropathic pain. Applications for marketing authorization for lacosamide are supported by data from placebo-controlled clinical trials of over 1,000 people with diabetic neuropathic pain. In these trials significant and sustained reductions in pain scores were seen versus placebo. The most common adverse events of lacosamide (greater than or equal to 10%) reported in these trials included dizziness and nausea.
About Diabetic Neuropathic Pain
Diabetic neuropathic pain is a painful and potentially debilitating complication of diabetes often characterized by a stabbing or burning sensation in the legs, feet and/or hands. It is caused by damage or dysfunction to the peripheral nervous system as a result of diabetes or impaired glucose tolerance. Diabetic neuropathic pain often substantially interferes with sleep, recreational activities, mobility, and normal work and social activities, and many patients with the condition experience a significantly reduced quality of life. 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.
UCB is a global leader in the biopharmaceutical industry dedicated to the research, development and commercialization of innovative pharmaceutical and biotechnology products in the fields of central nervous system disorders, allergy/respiratory diseases, immune and inflammatory disorders and oncology. Employing approximately 12,000 people in more than 40 countries, UCB achieved revenue of 3.6 billion euro in 2007. UCB is listed on the Euronext Brussels Exchange. Worldwide headquarters is located in Brussels, Belgium; U.S. headquarters is located in Atlanta, Georgia. For more information about UCB, visit www.ucb-group.com
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