A long-acting atypical antipsychotic that is given every three months could soon receive FDA approval after Janssen R&D announced that a Phase III study of paliperidone palmitate significantly delayed time to relapse compared to placebo.
The randomized, double-blind, placebo-controlled, relapse prevention study randomized patients to either the three-month paliperidone palmitate (Invega Sustenna) treatment group (n=160) or to the placebo group (n=145).
All enrolled patients met the DSM-IV diagnosis of schizophrenia and had a Positive and Negative Syndrome Scale (PANSS) total score of less than 120 at screening and baseline. Prior to randomization, individuals were first stabilized with paliperidone palmitate one-month formulation during a 17-week, open-label transition period.
Patients who met criteria for clinical stability then received a single three-month paliperidone palmitate injection during a 12-week, open-label maintenance phase. Stable patients were then randomized to treatment with either three-month paliperidone palmitate or placebo. Patients remained in the double-blind phase (n=305) until they relapsed, withdrew from the study, or the study terminated.
An interim analysis showed that three-month paliperidone palmitate significantly delayed time to relapse compared to placebo (HR 3.45; 95% CI: 1.73–6.88; p=0.0002; median time to relapse for placebo group: 274 days), according to study results published in JAMA Psychiatry. Final analysis confirmed three-month paliperidone palmitate’s superiority over placebo for delaying time to relapse of schizophrenia symptoms (HR 3.81; 95% CI: 2.08–6.99; p<0.0001; median time to relapse for placebo group: 395 days).
Three-month paliperidone palmitate was granted Priority Review by the FDA in January. The agency has a regulatory action date — the day when it will render a decision on approval — for May 18, 2015.
One-month paliperidone palmitate won FDA approval in July 2009.
Berwaets J, et al. Efficacy and Safety of the 3-Month Formulation of Paliperidone Palmitate vs Placebo for Relapse Prevention of Schizophrenia. JAMA Psychiatry. 2015; doi:10.1001/jamapsychiatry.2015.0241.