Janssen’s monthly antipsychotic approved in Europe
pharmafile | March 9, 2011 | News story | Sales and Marketing | Janssen, Xeplion, antipsychotic, injectible antipsychotic, paliperidone palmitate, schizophrenia
Janssen’s injectable antipsychotic Xeplion has been approved by the European Commission for the treatment of schizophrenia.
There is no cure for the mental illness but patients who cannot stick with treatment are up to five times more likely to relapse – increasing the chance of hospitalisation – than those patients who are adherent.
Antipsychotic medicines are the cornerstone of schizophrenia therapy and the attraction for regulators is that Xeplion (paliperidone palmitate) is a once-monthly, long-acting drug.
“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,” says Christophe Tessier, Janssen EMEA’s medical affairs director, psychiatry.
This approval is another boost for Janssen. Its oral, daily treatment Invega (paliperidone ER), which has the same active ingredient as Xeplion, became the first drug to be licensed in Europe to treat schizoaffective disorder in January.
In four double-blind placebo-controlled studies in patients with an acute exacerbation of schizophrenia, Xeplion was superior to placebo.
It improved symptoms measured by the change in the positive and negative syndrome scale (PANSS) total scores from baseline to endpoint.
Prevention of future relapses is a key goal of therapy, and in a further study, Xeplion “significantly” delayed time to relapse versus placebo.
During the double-blind phase, 10% of patients treated with Xeplion experienced a relapse compared with 34% in the placebo group.
“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 Fernando Cañas, head of psychiatry at Madrid’s Hospital Dr Rodríguez Lafora.
There has been significant activity in this therapy area in recent months, with NICE doing a u-turn on Bristol-Myers Squibb’s and Otsuka Pharmaceuticals’ Abilify (aripiprazole) by recommending it as a schizophrenia treatment for young people.
It is to be used in 15 to 17 year olds as an alternative to Johnson and Johnson’s Risperdal, because of intolerance or contraindications to that drug.
The lifetime risk for schizophrenia worldwide is estimated to be one person in 100 for men and women up to 60 years of age.
Adam Hill
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