Schizophrenia patients across the European Union are to get access to a new treatment option after European regulators issued a green light for Johnson & Johnson's Xeplion.
Xeplion (paliperidone palmitate) is a long-acting, injectable antipsychotic, and, given that the drug is administered just once a month, there are high hopes that it will address the significant problem of poor medicines adherence and thereby improve the rate of disease relapse, a key goal of treatment.
An estimated one percent of the world’s population suffers from schizophrenia, and according to J&J unit Janssen-Cilag International, those patients who fail to stick with their medication are up to five times more likely to relapse, significantly increasing the likelihood of hospitalisation which increases the overall cost of care.
As Professor Fernando Cañas, Head of Department of Psychiatry, Hospital Dr Rodríguez Lafora, Madrid, Spain, explained, more needs to be done to actively improve adherence to medication to help break this cycle of decline.
"Long-acting injectable antipsychotics such as Xeplion can help patients to maintain continual treatment, thereby reducing the likelihood of relapse," he said. This is "imperative not only to reduce the suffering and cost burden associated with relapse in schizophrenia, but to improve the future outlook and overall quality of life for these patients".
Xeplion' approval comes on the back of four double-blind placebo controlled studies which showed that the drug was superior to placebo in improving symptoms of schizophrenia and delaying time to relapse versus placebo, and, importantly, that the medicine was generally well tolerated by patients.
The drug was approved across the pond by the US Food ad Drug Administration in 2009, where it is sold as Invega Sustenna and pulled in sales of around $424 million last year, though analysts have predicted that it will become a blockbuster.