The company said it anticipates receiving the marketing authorisation from the European Commission by mid-year 2007.
The paliperidone prolonged release tablets marketing authorisation application is based on an extensive global development program. Paliperidone prolonged release tablets uses the OROS extended-release technology developed by Alza Corporation. This technology is designed to release medication in a uniquely designed pattern over a 24-hour period, leading to smooth blood plasma levels.
“In clinical trials, paliperidone prolonged release tablets has demonstrated good efficacy and favourable safety and tolerability. Importantly, paliperidone prolonged release tablets also showed significant improvement in patient functioning and that is an important aspect in the treatment of schizophrenia,” said professor Andreas Heinz, director, Department of Psychiatry at Charite University Medical Center CCM in Germany.