Janssen files for European approval of new formulation of schizophrenia drug

Janssen has submitted an extension marketing authorisation application to the European Medicines Agency for a new formulation of its schizophrenia drug paliperidone palmitate.

The new once-every-three-months formulation has shown its safety and efficacy in two phase III clinical trials and could represent a more convenient new dosing option.

Paliperidone palmitate is currently approved as a once-monthly atypical long-acting injection treatment for schizophrenia in more than 80 countries. In the EU, it is sold under the brand name Xeplion.

The once-every-three-months formulation contains the same active substance as Xeplion, but with an extended dosing interval. If approved, it will be marketed as Trevicta in Europe.

Dr Andreas Schreiner, European therapeutic area leader for neuroscience and pain at Janssen, said: "This treatment has the potential to offer patients a new dosing schedule, which may result in improved care for many people with schizophrenia."

Earlier this month, the company announced a new worldwide license agreement with Alligator Bioscience to develop ADC-1013, an innovative immuno-oncology agent.