A multinational, multicentre phase III study presented at the 159th annual meeting of the American Psychiatric Association showed that the investigational, once-a-day oral medication, Paliperidone extended release (ER) tablets, was effective in significantly reducing positive and negative symptoms in people suffering from schizophrenia versus those treated with placebo.
Importantly, this study also demonstrated improvement in patient functioning, as measured by the Personal and Social Performance scale (PSP) across a wide range of doses. This is the first time that the PSP scale has been incorporated into a pivotal clinical trial programme. Additionally, discontinuation rates due to adverse events for all Paliperidone ER dose groups were comparable to placebo.
"These data reinforce the findings of two other pivotal trials conducted for Paliperidone ER," said David P. Walling, chief clinical officer for Collaborative NeuroScience, and one of the study's investigators. "The results of this trial suggest both strong efficacy and good tolerability. If approved by the US FDA, Paliperidone ER may offer clinicians an important new treatment option with the potential to help patients control their symptoms and improve functioning," he added.
Paliperidone ER, a new chemical entity, is the first and only atypical antipsychotic to use the OROS extended release technology. This technology provides a continuous release of medication over a 24-hour period, leading to minimal peaks and troughs in plasma concentrations. Moreover, Paliperidone ER is not extensively metabolized by the liver and is excreted largely unchanged through the kidney.
Johnson & Johnson Pharmaceutical Research and Development, LLC, submitted a new drug application to the US FDA on November 29, 2005. And, earlier this month, Janssen-Cilag, NV, submitted a Marketing Authorization Application to European health authorities seeking approval. Paliperidone ER will be marketed in the United States by Janssen, L.P., and in Europe by Janssen-Cilag. Both companies, and Johnson & Johnson Pharmaceutical Research and Development, LLC, are wholly owned subsidiaries of Johnson & Johnson. The trade name for the product has not yet been determined.