Intramuscular paliperidone palmitate

Abstract

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.