Janssen’s Invega wins schizoaffective approval in Europe
pharmafile | January 6, 2011 | News story | Sales and Marketing | Invega, Janssen, paliperidone ER, schizoaffective disorder, schizophrenia
Janssen’s Invega has become the first drug to be licensed in Europe to treat schizoaffective disorder.
European regulators approved Invega (paliperidone ER) as a treatment for psychotic or manic symptoms of schizoaffective disorder, its symptoms are similar to schizophrenia and bipolar disorder but it’s now recognised as a separate disorder in its own right.
It is characterised by episodes of hypomania or psychosis, although symptoms experienced during this period are generally more moderate than in patients with bipolar disorder or schizophrenia.
Dr Christophe Tessier, medical affairs director, psychiatry, Janssen, said: “We are proud to be able to bring to market the first antipsychotic treatment for schizoaffective disorder in Europe – a difficult-to-diagnose condition associated with a high rate of hospitalisations and suicidal behaviour.”
In a phase III study, patients receiving the higher dose of Invega had a significant decrease in their symptom score compared with those receiving placebo (32.4 compared with 24.1), but the lower dose of the drug was not significantly different from placebo.
In a second study, patients treated with Invega who demonstrated prominent manic symptoms as measured by the Young Mania Rating Scale (YMRS) showed significant improvements in the symptoms of manic disorder when compared to placebo.
Both trials were international, randomised, double-blind, placebo-controlled, six-week studies in patients diagnosed with schizoaffective disorder.
In the first six-week study, 316 patients received one of two daily doses of Invega 6mg with the option to reduce to 3mg, or 12mg with the option to reduce to 9mg, or placebo.
In the second study, 311 patients were randomised to flexible doses of Invega, that were between three and 12 mg once daily either as monotherapy or in addition to treatment with mood stabilisers and/or antidepressants or placebo.
Dr Carla Canuso, Johnson & Johnson pharmaceutical R&D and lead investigator of the two studies, said: “These two studies combined represent the largest set of prospective data in patients with schizoaffective disorder and provide important insights into this understudied disease.
“Invega was proven to be effective both as a monotherapy and as an adjunctive therapy in reducing psychotic and manic symptoms and provides a welcome treatment option for this debilitating condition.”
Invega was developed as a follow-up to Janssen’s highly successful atypical antipsychotic Risperdal. It was first approved in Europe in 2007 and in 2009 won a licence from the FDA for the maintenance treatment of acute schizophrenia in adults.
Ben Adams
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