Janssen Research & Development LLC announced that following an Independent Data Monitoring Committee (IDMC) recommendation based on positive efficacy, it has halted early a Phase 3 clinical study of paliperidone palmitate three-month formulation, an investigational treatment for symptoms of schizophrenia in adults.
“We are really excited about this news because a medication’s ability to delay time to relapse in schizophrenia has significant clinical and societal implications,” said Husseini Manji, global head, neuroscience, Janssen Research & Development. “Being able to delay relapse can prove to be beneficial clinically to patients, to their caregivers and to the community.”
The international, randomized, multicenter, double-blind clinical trial evaluated the efficacy of paliperidone palmitate three-month formulation compared with placebo in delaying time to first occurrence of relapse of symptoms of schizophrenia. Study patients who were randomized to treatment were first stabilized with Invega Sustenna (paliperidone palmitate one-month formulation), an approved treatment for schizophrenia, prior to receiving the investigational three-month formulation.
The primary outcome measure of the study was the time to first relapse event in the double-blind phase of the study. Time to relapse is defined as the time between randomization to treatment in the double-blind phase and the first documentation of a relapse. The study began in April 2012 and 509 patients were enrolled.
The planned interim analysis was conducted after 60% (42 events) of projected relapses occurred. The primary analysis of this study will be based on the interim results of the efficacy endpoint of time to first relapse. Events experienced by study patients after the decision to stop the study will be included in an additional analysis of the primary efficacy endpoint.
The study results will be presented at a future medical congress and will also be submitted for publication in a peer-reviewed journal.
The recommendation to stop and unblind the clinical study at this interim analysis was made by an independent data monitoring committee based on pre-specified criteria, specifically, achieving a statistically significant difference from placebo in delaying time to relapse based upon the interim analysis after 42 relapse events have occurred.
Study investigators will have the opportunity to switch patients enrolled in the study to standard of care treatment for schizophrenia.
Following a final analysis of the study and discussions with the U.S. Food and Drug Administration (FDA), Janssen Research & Development LLC plans to file a New Drug Application with the FDA for paliperidone palmitate 3 month formulation by the end of 2014.
Invega Sustenna and the paliperidone palmitate three-month formulation utilize Alkermes’ proprietary NanoCrystal technology, which enables solubility of poorly water-soluble compounds.
Date: March 20, 2014
Source: Johnson & Johnson