Paliperidone ER: Reformulated antipsychotic for schizophrenia Tx
Risperidone’s metabolite behaves well but differently in once-daily delivery.
The study was halted at a planned interim analysis because time-to-recurrence was significantly longer for patients receiving paliperidone ER compared with placebo (P
Final analysis of the 179 patients who completed the study confirmed the interim findings. Ongoing treatment maintained improvement in patients’ acute symptoms, functioning, and quality-of-life measures.
Table 4
Studies of paliperidone ER in schizophrenia subpopulations
| Patient population | Study design | Findings |
|---|---|---|
| Recently diagnosed | 413 patients diagnosed within 5 years of study entry compared with 893 patients who had been ill ≥5 years*18,19 | Tolerability was similar, but recently diagnosed patients were more likely to experience movement disorders and somnolence |
| Age ≥65 years | 114 schizophrenia patients age ≥65 given paliperidone ER, 3 to 12 mg/d, or placebo in 6-week, double-blind, randomized, placebo-controlled trial20 | Rates of cardiovascular, cerebrovascular, neuromotor, and metabolic changes similar to placebo, except for tachycardia (16% with paliperidone vs 0% with placebo) |
| Severely ill | 217 patients with marked to severe symptoms (baseline total PANSS score ≥105)*21 | Patients treated with paliperidone showed significantly greater improvement vs placebo in mean total PANSS score (–26.7 vs –5.7) and other measures |
| Substantial negative symptoms | 299 patients with predominant negative symptoms from 3 acute efficacy trials*22 | Patients treated with paliperidone showed significant improvements vs placebo on primary and secondary measures of negative symptoms |
| Sleep problems | 36 patients age 18 to 45 diagnosed with schizophrenia and schizophrenia-related insomnia*23 | In stable patients, paliperidone improved sleep architecture, continuity, and patient-rated sleep quality without producing or worsening daytime sleepiness |
| * Studies marked with asterisks represent post hoc analyses of data from the 3 clinical trials on which the FDA based its approval of paliperidone ER. | ||
| PANSS: Positive and Negative Syndrome Scale | ||
- Paliperidone extended release. Prescribing information. www.invega.com.
- Johnson & Johnson. U.S. District Court upholds Risperdal® (risperidone) patent (press release). October 16, 2006. www.jnj.com/news/jnj_news/20061016_094453.htm.
- Carbamazepine • Tegretol
- Lorazepam • Ativan
- Olanzapine • Zyprexa
- Paliperidone ER • Invega
- Risperidone • Risperdal
Dr. Rado and Dr. Dowd receive research support from Neuronetics, sanofi-aventis, Janssen Pharmaceutica, and Solvay.
Dr. Janicak receives research support from Astra-Zeneca, Bristol-Myers Squibb, Janssen Pharmaceutica, Neuronetics, Solvay, and sanofi-aventis. He is a consultant to Astra-Zeneca, Bristol-Myers Squibb, Janssen Pharmaceutica, Neuronetics, and Solvay, and a speaker for Abbott Laboratories, Astra-Zeneca, Bristol-Myers Squibb, Janssen Pharmaceutica, and Pfizer.
