Intramuscular paliperidone palmitate.
Author(s): Hoy SM, Scott LJ, Keating GM.
Affiliation(s): Adis, a Wolters Kluwer Business, Auckland, New Zealand. demail@adis.co.nz
Publication date & source: 2010, CNS Drugs. , 24(3):227-44
Intramuscular paliperidone palmitate is a long-acting, atypical antipsychotic
that is indicated in the US for the acute and maintenance therapy of adult
patients with schizophrenia. Paliperidone is the major active metabolite of
risperidone. The noninferiority of flexible doses of intramuscular paliperidone
palmitate 39-156 mg to flexible doses of intramuscular long-acting risperidone
25-50 mg was not established in an initial 53-week study. However, these data
were utilized to optimize the intramuscular paliperidone palmitate dosage
regimen. In four randomized, double-blind studies, intramuscular paliperidone
palmitate 39-234 mg was generally effective in the treatment of adult patients
with acute schizophrenia, inducing significantly greater improvements from
baseline in the mean Positive and Negative Syndrome Scale (PANSS) total score
than placebo (primary endpoint). In general, intramuscular paliperidone palmitate
recipients achieved significantly better outcomes than placebo recipients with
regard to the PANSS subscale, PANSS factor, Personal and Social Performance scale
and Clinical Global Impressions-Severity scale scores. As maintenance therapy,
intramuscular paliperidone palmitate 39-156 mg was significantly more effective
than placebo in delaying the time to the first relapse of schizophrenia symptoms
in adult patients, according to the results of a randomized, double-blind study.
The beneficial effects of intramuscular paliperidone palmitate therapy on the
PANSS total score were sustained in a 52-week noncomparative extension phase of
the maintenance therapy study. Intramuscular paliperidone palmitate 39-234 mg was
generally well tolerated in adult patients with schizophrenia.
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