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

Study shows paroxetine produced no significant drug interaction with paliperidone ER

SAN DIEGO, May 22, 2007 /PRNewswire/ -- After administration of paliperidone extended-release (ER) tablets, blood levels of the drug were not affected when given with a common antidepressant, according to new data presented today at the 160th Annual Meeting of the American Psychiatric Association. Paroxetine, a selective serotonin reuptake inhibitor (SSRI), is an antidepressant known to interact with several antipsychotic medications. This new study showed there was no clinically significant increase in paliperidone exposure when paroxetine was administered with paliperidone ER.(1)

Many medications prescribed for psychiatric illnesses are metabolized in the liver by a specific enzyme called CYP2D6. Administering more than one drug metabolized by CYP2D6 may cause drug-drug interactions. Paroxetine is a potent inhibitor of the CYP2D6 enzyme, and can inhibit the metabolism of some atypical antipsychotic drugs. Approximately 50 percent of patients with schizophrenia have at least one other psychiatric or medical condition requiring medication, most commonly depression.(2)

"Drug interactions frequently occur in patients with schizophrenia because this population is often treated for multiple medical and psychiatric conditions," said Dr. Joseph Palumbo, Franchise Medical Leader for Psychiatry, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. "Drug interactions are an under appreciated factor that can reduce optimal treatment outcomes in our patients. This study shows that paliperidone ER can be an important new option for patients with schizophrenia who also require treatment with an antidepressant metabolized through the CYP2D6 system."

    In this study 60 healthy male patients were randomized to receive either:

    -- Treatment A: 1 tablet of paliperidone ER 3mg (Day 1)

    -- or tr
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