Xeplion: new monthly injectable atypical antipsychotic

Xeplion is indicated for the maintenance treatment of schizophrenia in patients stabilised on paliperidone or risperidone, and those with mild to moderate psychotic symptoms who previously responded to oral paliperidone or risperidone.

Xelpion does not require refrigeration, reconstitution or oral antipsychotic supplementation
Xelpion does not require refrigeration, reconstitution or oral antipsychotic supplementation

(paliperidone palmitate) is slowly hydrolysed to paliperidone in the body. Paliperidone predominantly blocks serotonergic 5HT2 and dopaminergic D2 receptors.1

The efficacy of paliperidone palmitate for the acute treatment of schizophrenia was assessed in four (one 9-week and three 13-week) double-blind studies. Patients received placebo or paliperidone palmitate doses equivalent to paliperidone 25mg, 50mg, 100mg or 150mg by gluteal or deltoid injection on days 1, 8 and 36 (with additional dose on day 64 in the 13-week studies). In all studies, a significantly greater decrease in Positive and Negative Syndrome Scale (PANSS) score from baseline was seen for paliperidone palmitate than for placebo, except among patients receiving the 50mg dose in one study.2,3,4,5

In a double-blind extension study (n=410), patients receiving paliperidone palmitate had a longer time to relapse than placebo at both interim and final analysis (both p<0.0001).6


  1. Xeplion Summary of Product Characteristics, March 2011.
  2. Pandina GJ et al. J Clin Psychopharmacol 2010; 30: 235–44.
  3. Nasrallah HA et al. Neuropsychopharmacol 2010; 35: 207–82.
  4. Gopal S et al. Int Clin Psychopharmacol 2010; 25: 247–56
  5. Kramer M et al. Int J Neuropsychopharmacol 2010; 13: 635–47.
  6. Hough D et al. Schizophr Res 2010; 116: 107–17.

View Xeplion drug record

Further Information: Janssen

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