Johnson & Johnson's paliperidone ER improves schizophrenia symptoms, studies say

By Angela McDaniels

Seattle, Dec. 14 - Johnson & Johnson Pharmaceutical Research and Development LLC said its paliperidone extended release tablets were effective in significantly improving symptoms in patients with schizophrenia versus those treated with placebo in two clinical trials.

The investigational, once-a-day oral medication also demonstrated significant improvements in mean total scores of the Positive and Negative Syndrome Scale versus a placebo for all doses tested in both studies.

The scale is a multi-item inventory that measures positive symptoms, negative symptoms, disorganized thoughts, uncontrolled hostility/excitement and anxiety/depression.

Paliperidone ER also demonstrated improvements in the Personal and Social Performance Scale versus placebo in both trials, with statistical significance achieved in four of the five paliperidone ER treatment arms, the company said.

The Personal and Social Performance Scale is a clinician-rated scale that measures personal and social functioning in four domains of behavior: socially useful activities including work and study, personal and social relationships, self care and disturbing and aggressive behaviors.

Discontinuation rates due to adverse events for all paliperidone ER dose groups were comparable to the placebo, the company said.

Schizophrenia affects more than 2 million Americans and is characterized by symptoms such as hallucinations, delusions, social withdrawal and a diminished capacity for organized thought.

Paliperidone ER is the first anti-psychotic to use the patented OROS extended-release technology, the company said, which provides a steady release of medication over a 24-hour period. In addition, it is not extensively metabolized by the liver and is excreted largely unchanged through the kidney.

Johnson & Johnson submitted a New Drug Application for the drug to the Food and Drug Administration on Nov. 29. The paliperidone ER filing is based on an extensive global clinical development program that involved more than 1,600 patients in 23 countries, the company said.

If approved, paliperidone ER will be marketed in the United States by Janssen LP, a wholly owned subsidiary of Johnson & Johnson. The trade name for the product has yet to be determined.

Janssen is based in Titusville, N.J., and currently markets prescription medications for the treatment of schizophrenia and bipolar mania.

Based in New Brunswick, N.J., Johnson & Johnson is manufacturer of health care products for the consumer, pharmaceutical, medical devices and diagnostics markets.

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