Date: 2012-06-12
Type of information: Initiation of preclinical development
phase: 3
Announcement: initiation
Company: Alkermes (USA - Ireland) Janssen Research & Development (J&J - USA)
Product: Three-Month Formulation of Invega® Sustenna® (paliperidone palmitate)
Action mechanism:
Disease: schizophrenia
Therapeutic area: CNS diseases - Mental diseases
Country:
Trial
details: Two phase 3 studies of the three-month formulation of Invega® Sustenna® have been initiated and are expected to enroll approximately 1,800 patients with schizophrenia.
The first study is a randomized, multicenter, double-blind, parallel-group, fixed-dose, relapse-prevention study and will explore the efficacy, safety and tolerability of the three-month formulation oInvega® Sustenna®, compared to placebo. Approximately 500 patients with schizophrenia will be enrolled in the study. The primary efficacy endpoint of the study is time to first relapse event during the double-blind phase.
The second phase 3 study is a randomized, double-blind, parallel-group, multicenter, non-inferiority study comparing the three-month and one-month formulations of Invega® Sustenna®. Approximately 1,300 patients with schizophrenia will be enrolled in the study. The primary efficacy endpoint of the study is the percentage of patients who have not relapsed at the end of the 48-week, double-blind portion of the study.
Latest
news: Alkermes has announced that Janssen Research & Development has initiated a phase 3 clinical research program for a three-month formulation of Invega® Sustenna® (paliperidone palmitate), an injectable medicine for the treatment of schizophrenia.
The investigational product is being developed by Janssen Pharmaceutica, NV, licensee to Alkermes\' proprietary technology for nanoparticles. Two phase 3 studies are expected to enroll approximately 1,800 patients with schizophrenia and will assess the efficacy, safety and tolerability of the three-month injectable formulation. These clinical studies are expected to be completed in the second half of calendar 2014.
Invega® Sustenna® was approved as a once-monthly injectable medication for schizophrenia in the U.S. in 2009. It was also approved in the EU in 2011, where it is available under the trade name Xeplion®. Invega® Sustenna® is marketed worldwide by the Janssen Pharmaceutical Companies and it incorporates Alkermes' proprietary technology for nanoparticles, and Alkermes earns a royalty on worldwide sales of the product.
