Janssen-Cilag International NV announced that Xeplion (paliperidone palmitate), a once monthly, long-acting injectable, antipsychotic, has received approval from the European Commission for the treatment of schizophrenia.

Schizophrenia is relatively common and the prevalence is similar around the world. The lifetime risk for schizophrenia is estimated to be one person in 100, and appears to be the same for men and women up to age 60 years. Schizophrenia is a devastating mental illness for both the patients and their families and friends, as it seriously impairs a person’s ability to think clearly, relate to others and to function properly in society.  While there is no cure, many people with the illness respond well to antipsychotic medicines, the mainstay of treatment for schizophrenia.

However, further relapses can have a terrible effect on the lives of patients with schizophrenia and their families. Frequent relapses and hospitalisation can increase the person’s isolation and make it even more difficult for them to find and keep a job. Prevention of future relapses is a crucial goal of therapy and patients who stay on continual treatment are more likely to achieve optimal outcomes.

Patients with schizophrenia who are non-adherent to medication are up to five times more likely to relapse than those patients who are adherent and continue on medication, significantly increasing the likelihood of hospitalisation, which in turn increases the overall cost of care.

“Relapse can have a devastating effect on patients with schizophrenia and more needs to be done to actively improve adherence to medication if we are to break the cycle of decline,” said Professor Fernando Cañas, Head of Department of Psychiatry, Hospital Dr Rodríguez Lafora, Madrid, Spain. “Long-acting injectable antipsychotics such as Xeplion can help patients to maintain continual treatment, thereby reducing the likelihood of relapse. 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.”

The efficacy of Xeplion was established in four double-blind placebo controlled studies in patients with an acute exacerbation of schizophrenia and a longer-term double blind  relapse prevention/maintenance study. Xeplion was superior to placebo in improving symptoms of schizophrenia as measured by the change in the positive and negative syndrome scale (PANSS) total scores from baseline to endpoint in the acute treatment trials and significantly delayed time to relapse vs. placebo in the longer-term maintenance study.

The most recent acute symptom control study was a multi-centre, randomised, placebo-controlled, double-blind, parallel-group study (n=636). All patients received a dose of 150 mg eq. on Day 1 in the deltoid muscle. From Day 8 and monthly thereafter, patients were assigned to one of three fixed doses of Xeplion (25, 100 and 150 mg eq) administered into either the deltoid or gluteal muscle for a period of 13 weeks. All three doses of Xeplion were superior to placebo in improving the PANSS total score at endpoint (the primary measure of efficacy). The results support efficacy across the entire duration of treatment, with onset of efficacy and significant improvement in PANSS compared to placebo observed from day 8 in some patients.  The results of the other studies also yielded significant results in favour of Xeplion.

The efficacy of Xeplion in maintaining symptomatic control and delaying relapse in schizophrenia was established in a longer-term, randomised, double-blind, placebo-controlled, flexible-dose  study involving 849  patients with schizophrenia.  A total of 410 stabilised patients were randomised to either Xeplion or to placebo until they experienced a relapse of schizophrenia symptoms in the variable length double-blind phase of the study. The trial was stopped early for efficacy reasons as a significantly longer time to relapse (p < 0.0001) was seen in patients treated with Xeplion compared to placebo.  During the double-blind phase of the study, fewer patients treated with Xeplion experienced a relapse (10% [n=15/156]) compared with those in the placebo group (34% [n=53/156]). The final analyses confirmed the results of the interim analysis.

 “Xeplion provides healthcare professionals with the opportunity to rethink their overall approach to how they treat schizophrenia by using long-acting therapies,” says Dr Christophe Tessier, Medical Affairs Director, Psychiatry, Janssen EMEA. “The approval of Xeplion demonstrates Janssen’s ongoing commitment to providing novel therapies for schizophrenia.  As a once monthly injection, Xeplion can help healthcare professionals address the issue of non-adherence to medication thus ensuring symptom control and allowing patients to focus on shaping their lives.”

Xeplion is a once-monthly, long-acting, injectable, atypical antipsychotic. Xeplion will be available in Europe in milligrams (mg) of paliperidone palmitate in dose strengths of 25, 50, 75, 100 and 150 mg. After the first two initiation injections, Xeplion can be administered in either the deltoid (arm) or gluteal (buttock) muscle.

Xeplion is indicated for maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone. In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, Xeplion may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed.

Janssen- Cilag International NV is one of the Janssen Pharmaceutical Companies of Janssen Pharmaceutical  which are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology (e.g. multiple myeloma and prostate cancer), immunology (e.g. psoriasis), neuroscience (e.g. schizophrenia, dementia and pain), infectious disease (e.g. HIV/AIDS, Hepatitis C and tuberculosis), and cardiovascular and metabolic diseases (e.g. diabetes).