RxTrials Institute Drug Pipeline Alert

Janssen-Cilag announced that the European Commission granted marketing authorization for Invega, a schizophrenia treatment.

Once-daily Invega (paliperidone prolonged-release tablets), a new atypical antipsychotic medication for the treatment of schizophrenia is specifically designed to deliver paliperidone — the active ingredient in Invega — through an osmotic delivery system, according to Janssen-Cilag.

The decision of the European Medicines Agency to grant a marketing authorization for Invega in the EU is based on: three six-week, placebo-controlled clinical studies involving more than 1,600 patients with acute schizophrenia in 23 countries; a long-term (40 weeks) double blind, placebo-controlled study looking at prevention of symptom recurrence in 207 randomized patients; and another double blind, placebo-controlled study assessing safety and tolerability in 114 elderly patients.

The recommended dose of paliperidone prolonged-release tablets is 6 mg administered in the morning, taken in a consistent manner with or without food.