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Blood Levels of Paliperidone Extended-Release Tablets are Not,Increased by Common Antidepressant

eatment B: 20mg of paroxetine daily (Day 1-13) with 1 tablet of paliperidone ER 3mg on Day 10.

After completing their first treatment the patients took no medication for 14 days. Then patients who had received treatment A received treatment B and vice versa.

Four days after paliperidone ER administration, the investigators measured the maximum concentration of the drug in the body and total exposure over time to paliperidone ER. No clinically significant increase in paliperidone exposure was seen when paliperidone ER was administered together with paroxetine compared with paliperidone ER given alone.

There were no serious adverse events or clinically important changes in laboratory values, vital signs or cardiac parameters.

"These results demonstrate that prescribers can administer a CYP2D6- inhibiting antidepressant, paroxetine, with paliperidone ER without having to adjust the dose of paliperidone ER," Palumbo said. "This, when combined with once-daily oral dosing and well demonstrated efficacy, safety, and tolerability, adds to paliperidone ER's usefulness as a new option for the treatment of schizophrenia."

The study was sponsored by Janssen, L.P. Janssen is exclusively dedicated to mental health and committed to providing new treatment options, such as paliperidone ER, to patients with psychiatric illnesses.

About Schizophrenia

Worldwide, it is estimated that 1 person in every 100 develops schizophrenia, one of the most serious types of mental illness. In the United States, there are currently 2,000,000 people with schizophrenia, with men and women affected equally. The disease is marked by positive symptoms (hallucinations and delusions) and negative symptoms (depression, blunted emotions, and social withdrawal), as well by disorganized thinking.

Janssen, L.P., based in Titusville, N.J., is the only pharmaceutical company in the U.S. dedicated solely to mental health. The company currently mar
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