Importantly, the 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 program.
Paliperidone extended release (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.
The double-blind, parallel-group, dose-response study of 618 patients was designed to assess the efficacy, safety and effect on functioning of paliperidone ER at daily doses of 3mg, 9mg or 15mg versus placebo.
All three doses of paliperidone ER demonstrated significant improvements in mean total scores and in each of the five factor scores of the positive and negative syndrome scale (PANSS) versus placebo. All doses of paliperidone ER also demonstrated significant improvements in patient functioning versus placebo as measured by the PSP scale.
Additionally, discontinuation rates due to adverse events for all paliperidone ER dose groups were comparable to placebo.
Johnson & Johnson Pharmaceutical R&D submitted a new drug application to the FDA for paliperidone ER in November 2005 and Janssen-Cilag submitted a marketing authorization application to European health authorities seeking approval in May 2006.
The paliperidone ER filing is based on an extensive global clinical development program that involved more than 1,600 patients in 23 countries. Upon approval by regulatory authorities, the drug will be marketed in the US by Janssen and in Europe by Janssen-Cilag, both of which are wholly owned subsidiaries of Johnson & Johnson. The trade name for the product has not yet been determined.
“These data reinforce the findings of two other pivotal trials conducted for paliperidone ER,” said Dr David Walling, chief clinical officer for Collaborative NeuroScience and one of the study’s investigators. “If approved by the FDA, paliperidone ER may offer clinicians an important new treatment option with the potential to help patients control their symptoms and improve functioning.”