Invega Sustenna paliperidone palmitate: Phase III data

A double-blind, international Phase III trial in 509 patients with schizophrenia was stopped early on the recommendation of an independent DMC after an interim analysis showed that a 3-month formulation of intramuscular Invega Sustenna met the primary endpoint of delaying time to first relapse in the double-blind portion of the trial vs. placebo. The interim analysis was conducted after 42 events, or 60% of projected relapses, occurred. The trial included a 17-week open-label transition portion and a 12-week fixed-dose, open-label maintenance portion prior to the double-blind, placebo-controlled portion. ...