Drug updated on 11/1/2024
| Dosage Form | Injection (intramuscular; 39 mg/0.25 mL, 78 mg/0.5 mL, 117 mg/0.75 mL, 156 mg/mL, or 234 mg/1.5 mL) |
| Drug Class | Atypical antipsychotics |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for treatment of schizophrenia in adults
- Indicated for treatment of schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants.
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Summary
- This summary is based on the review of eight systematic review(s)/meta-analysis(es). [1-8]
- Paliperidone palmitate (PP1M) significantly reduced PANSS (Positive and Negative Syndrome Scale) total scores, with short-term, medium-term, and long-term reductions of -21.69, -14.98, and -17.88, respectively; approximately 50% of patients reported at least a 30% reduction in PANSS scores at short-term follow-up.
- Long-term relapse and hospitalization rates for patients on PP1M were 12% and 18%, respectively, with noted reductions in inpatient visits and hospital stay lengths for those who transitioned from oral antipsychotics.
- PP1M demonstrated significant PANSS score reductions compared to placebo. Comparisons with paliperidone extended-release (PAL-ER) showed no significant differences in PANSS scores or all-cause discontinuation, although PAL-ER was associated with higher blood prolactin levels.
- Adverse Events: Low rates of treatment discontinuation and adverse events were observed, with no new or unexpected adverse effects from combining two LAI antipsychotics. Increased blood prolactin levels were noted for both PP1M and PAL-ER compared with placebo in both females and males.
- Comparative Safety: PAL-ER was associated with a more significant increase in blood prolactin levels compared to PP1M, with no other significant differences in safety outcomes. Dual LAI therapy with PP1M showed no new or unexpected adverse effects, suggesting an acceptable safety profile.
- Acute stage patients with schizophrenia and those with shorter illness duration showed better improvements in PANSS and CGI-S scores. Adolescents (12-17 years) with schizophrenia spectrum disorders demonstrated symptom improvement with an acceptable safety profile. Patients switching from oral antipsychotics to PP1M, especially with early initiation and switching due to factors other than lack of efficacy, exhibited enhanced PSP score improvements.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Invega Sustenna (paliperidone palmitate) Prescribing Information. | 2024 | Janssen Pharmaceuticals, Inc., Titusville, NJ |