The European Commission granted marketing authorization for Invega, an atypical antipsychotic medication for the treatment of schizophrenia. This once-daily medication is specifically designed to deliver paliperidone—the drug’s active ingredient—through the osmotic delivery system (OROS). In clinical trials, Invega demonstrated significant efficacy controlling the symptoms of schizophrenia compared to placebo and was generally well tolerated. Invega is the first treatment for schizophrenia approved in the EU that uses the OROS delivery system.

Invega will be marketed in Europe by Janssen-Cilag and in the U.S., the product is marketed by Janssen, L.P. as Invega Extended-Release Tablets. Both are subsidiaries of Johnson & Johnson.

The marketing authorization was granted based on efficacy and safety results of an extensive clinical development program that included: three six-week, placebo controlled clinical studies involving more than 1,600 patients with acute schizophrenia in 23 countries, a 40-week double blind, placebo controlled study in 207 patients examining time to relapse, and another study assessing safety and tolerability in 114 elderly patients suffering from schizophrenia.