01-06-2011 | Adis Drug Evaluation
Oral Paliperidone
A Review of its Use in the Management of Schizoaffective Disorder
Published in: CNS Drugs | Issue 6/2011
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Oral paliperidone extended or prolonged release (Invega®) is an atypical antipsychotic, and is the first agent approved for the treatment of schizoaffective disorder. Paliperidone (or 9-hydroxyrisperidone) is the major active metabolite of the well known atypical antipsychotic risperidone, and its mechanism of action is thought to be the antagonism of dopamine D2 and serotonin 5-HT2a receptors.
The clinical efficacy of paliperidone was demonstrated in two 6-week, randomized, double-blind, placebo-controlled, multicentre trials in patients with schizoaffective disorder. One trial was flexible dose in design (3–12mg/day) and the other was fixed dose in design (3–6 and 9–12mg/day). Compared with placebo, the change from baseline at study end in the Positive and Negative Syndrome Scale (PANSS) total score (primary endpoint) was significantly greater with paliperidone 3–12mg/day in one trial and with 9–12mg/day (but not 3–6mg/day) in the other trial. However, pooled analyses reported a significantly greater change in PANSS total score across all paliperidone dosages than with placebo.
Paliperidone was generally well tolerated in the 6-week trials, and no unexpected adverse events were reported. The most commonly reported treatment-emergent adverse events were headache, tremor, dizziness, insomnia, nausea, akathisia, dyspepsia, hypertonia, somnolence and sedation.
Although long-term efficacy and tolerability data and comparisons with other antipsychotics are needed, paliperidone appears to be a useful agent for the short-term management of patients with schizoaffective disorder.