Reboxetine: Phase III data; NDA under review, marketed in Europe

Data from two Phase III studies involving a total of 549 patients in Europe, Latin America and Australia showed that reboxetine had similar efficacy and adverse event rates as Eli Lilly's Prozac fluoxetine selective serotonin reuptake inhibitor. One of the studies was placebo-controlled and both included a Prozac arm. In the non-placebo-controlled trial, reboxetine gave a 19.2 point reduction in Hamilton Depression Scale score versus a 16.8 point reduction with Prozac. In the second trial, the reduction was 13.4 points with reboxetine, 13.3 points with Prozac and 8.7 points with placebo. Side effects of reboxetine included dry mouth, insomnia and constipation. ...