Extended-release paliperidone reduces positive and negative symptoms of schizophrenia and improves personal and social functioning

New data from a multinational phase III study indicate that extended-release paliperidone (paliperidone ER) effectively reduces positive and negative symptoms and improves personal and social performance in patients with schizophrenia, according to a presentation at the annual meeting of the American Psychiatric Association.

The current study is the first to incorporate the Personal and Social Performance (PSP) scale into a pivotal clinical trial. In addition, discontinuation rates due to adverse events for all paliperidone dose groups were comparable to those for placebo.

"These data reinforce the findings of two other pivotal trials conducted for paliperidone ER," said David P. Walling, PhD, 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."

Paliperidone ER is the first and only atypical antipsychotic to use the OROS(R) 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 ER is not extensively metabolized by the liver and is excreted largely unchanged through the kidney.

The current study was a double-blind, parallel-group, dose-response study of 618 patients that assessed efficacy, safety and effect on functioning of paliperidone ER at daily doses of 3 mg, 9 mg or 15mg.

All three doses of paliperidone ER demonstrated significant improvements in mean total scores and in each of the five factor scores of the Positive and Negative Syndrome Scale (PANSS) versus placebo.

All doses of paliperidone ER also demonstrated significant improvements in patient functioning versus placebo as measured by the PSP scale. The PSP scale 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.

 

 


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