Janssen-Cilag International NV (Janssen) has submitted an extension Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for paliperidone palmitate once-every-three-months formulation for the treatment of schizophrenia. If approved, it will be the first antipsychotic schizophrenia medication to be administered four times a year.

"This treatment has the potential to offer patients a new dosing schedule, which may result in improved care for many people with schizophrenia. We look forward to working with the EMA to make this long-acting therapy available for the treatment of patients with schizophrenia in Europe," said Dr Andreas Schreiner, European therapeutic area leader, neuroscience and pain, Janssen.

The European filing of paliperidone palmitate once-every-three-months is based on two phase 3 studies. The first, which was the basis for the US Food and Drug Administration (FDA) submission, is a randomised, multi-centre, double-blind, placebo-controlled relapse prevention study in more than 500 patients with schizophrenia. The second is a randomised, double-blind non-inferiority clinical trial of paliperidone palmitate once-every-three-months and once-monthly formulations. The results will be presented at a scientific congress later this year.

Paliperidone palmitate once-monthly (marketed as Xeplion in the European Union) is an atypical long-acting injection to treat schizophrenia and is now approved in more than 80 countries. It can help people with schizophrenia to maintain continuous treatment, control their symptoms and avoid relapse. This may allow people with the condition to focus on shaping their future and living their life, which can include returning to work or study, independent living and social relationships. Paliperidone palmitate once-every-three-months formulation, which obtained FDA priority review and is currently approved and launched in the US (and marketed as Invega Trinza) for patients previously treated with the once-monthly formulation, contains the same active substance as Xeplion but with an extended dosing interval. If approved, it will be marketed as Trevicta in Europe.

Schizophrenia is a complex illness in which a person has difficulties in their thought processes, leading to hallucinations, delusions, disordered thinking and unusual speech or behaviour (known as psychotic symptoms). These symptoms mean that people with schizophrenia can find it difficult to interact with others and may withdraw from everyday activities and the outside world. In addition, many people with schizophrenia find it difficult to take their medication continuously, and even short interruptions can lead to a relapse. If approved, this additional once-every-three-months treatment option would offer healthcare professionals the ability to give suitable patients greater independence by enabling them to focus less on taking their medication and more on other aspects of their treatment plan.

Schizophrenia affects people from all countries, socio-economic groups and cultures. Its prevalence is similar around the world - almost one person in every 100 will develop schizophrenia before they reach the age of 60, with men and women equally at risk.

There is no single cause of schizophrenia. Different factors acting together are thought to contribute to the development of the illness. Both genetic and environmental factors seem to be important. The symptoms of schizophrenia can include hallucinations, delusions, lack of emotional response, social withdrawal/depression, apathy and a lack of drive or initiative.

While schizophrenia is typically a lifelong condition, it is important to remember that there are treatments available that allow people with schizophrenia to get better. Clinical guidelines recommend that the optimal treatment package for people with schizophrenia is a combination of medication along with psychotherapy, psycho-education and self-help. Beyond simply controlling symptoms, effective treatment may allow people with the condition to enjoy a more fulfilling, well rounded life, which may include returning to work or study, independent living and social relationships, which in turn can aid their recovery.