FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs / Research and Development

Janssen Schizophrenia Drug Aces Phase III Trial

March 21, 2014

An independent data monitoring committee has stopped a Phase III trial of a schizophrenia drug developed by Janssen early after the treatment showed statistically significant results in delaying the time to relapse, the Johnson & Johnson subsidiary said Thursday.

The international, randomized and double-blind study evaluated a three-month formulation of paliperidone palmitate in patients whose schizophrenia had appeared more than one year prior to the start date of April 2012.

A one-month formulation of the drug is already approved by the FDA as a maintenance treatment of schizophrenia.

Janssen hopes that a final analysis of study results, along with discussions with the FDA, will support a late-2014 NDA submission. — Lena Freund

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