Ph IIa results for UCB's lacosamide positive but fate of drug rests on further analysis

Belgian drugmaker UCB has reported positive but inconclusive results from the first-line analyses of a Phase IIa trial of lacosamide in fibromyalgia syndrome. The initial findings from this proof-of-concept study showed activity in FMS but require further analysis, the firm noted. A decision to start Phase IIb will be made by the end of the year. In the randomized, placebo-controlled and double-blind trial, assessing 400mg per day of oral lacosamide, the primary variable was a within-subject change in average daily pain score from baseline to the last two weeks of the treatment phase using an 11-point Likert scale. Based on the 158 patients in the full analysis set, an effect size of 0.5 in favor of lacosamide versus placebo was observed for the primary variable.