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=