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.
It is hoped that the new three-month version will go even further in boosting treatment adherence rates. As Janssen notes, patients with acute illness often do not have insight about their disease, which contributes their not taking medication or using treatment services, potentially leading to relapse.
“This innovative three-month formulation has the potential to positively affect the care of many people with schizophrenia,” commented Husseini Manji, head of neuroscience at Janssen R&D. “The option for this dosing schedule would offer a welcome new choice for patients and may provide benefits to society.”
