Johnson & Johnson group Janssen has filed an application in the US to market a three-month injectable formulation of paliperidone palmitate for the treatment of schizophrenia.

The move is a huge step towards providing patients with the first and only long-acting atypical antisphychotic that has a four times a year dosing schedule.

The filing comes on the back of data from a Phase III relapse prevention study of the drug involving more than 500 patients, which was halted and unblinded early on the advice of an independent data monitoring committee, because a statistically significant difference from placebo in delaying time to relapse was observed.

Also, the study showed the safety profile of paliperidone palmitate three-months to be consistent with that of its once-monthly predecessor Invega Sustenna (paliperidone palmitate), approved by the US Food and Drug Administration back in 2009.

For more details, go to: http://www.pharmatimes.com/Article/14-11-19/Janssen_files_four-times-a-year_schizophrenia_shot.aspx