Johnson& Johnson's paliperidone tablets show efficacy in treating schizophrenia patients

By Elaine Rigoli

Tampa, Fla., May 23 - Johnson & Johnson said Tuesday that a multinational, multi-center phase 3 study presented at the American Psychiatric Association annual meeting showed that the investigational, once-a-day oral medication paliperidone extended-release (ER) tablets were effective in significantly reducing positive and negative symptoms in people suffering from schizophrenia versus those treated with a placebo.

Importantly, this study also demonstrated improvement in patient functioning, the company said in a news release.

"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 U.S. Food and Drug Administration, 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 atypical antipsychotic to use the OROS extended-release technology, the release said.

This technology provides a continuous release of medication over a 24-hour period, leading to minimal peaks and troughs in plasma concentrations, the release noted.

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 Food and Drug Administration Nov. 29, 2005. Earlier this month, Janssen-Cilag, NV submitted a Marketing Authorization Application to European health authorities seeking approval.

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 United States by Janssen, LP and in Europe by Janssen-Cilag.

Both companies, and J&J Pharmaceutical Research and Development, are wholly owned subsidiaries of Johnson & Johnson.

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