Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.An FDA advisory committee review of Johnson & Johnson's new drug application for the schizophrenia treatment paliperidone ER has been cancelled after the agency's Division of Psychiatry Products said that it has not yet identified any issues with the application that require feedback.
Subscribe to our email newsletter
Paliperidone, 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 is not extensively metabolized by the liver and is excreted largely unchanged through the kidney.
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, paliperidone ER will be marketed in the US by Janssen, L.P. and in Europe by Janssen-Cilag. Both companies are wholly owned subsidiaries of Johnson & Johnson. The trade name for the product has not yet been determined.