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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