Xeplion(paliperidone palmitate)
Psychiatry· 433 cited findings· 1 source document
Company: Johnson & Johnson →
What the regulatory reviews say
Xeplion (paliperidone palmitate) is indicated for the treatment of adult patients with schizophrenia. The Marketing Authorisation application was submitted on 3 December 2009, with a CHMP positive opinion for Marketing Authorisation issued on 16 December 2010. The Marketing Authorisation in the United States was granted on 31 July 2009. The onset of efficacy for paliperidone palmitate is 8 days.
In efficacy studies, the relapse rate was 34.0%. Subjects experiencing recurrence ranged from 9.6% to 47.8%, with a time to recurrence p-value of <0.0001. The PANSS total score change from baseline (LS mean difference) was -8.6 to -14.0, and the CGI-S score change from baseline (LS mean difference) was -0.2. The CGI-S score change from baseline had p-values of <0.0001 to 0.004. The responder rate had a p-value of <0.001.
Safety data includes 3605 subjects exposed to paliperidone palmitate, with a cumulative exposure of 1559.8 to 1704.8 patient-years. The treatment-emergent adverse events rate was 70% to 75%.
Key figures — cited to the source page
| Relapse rate | 34.0 | Johnson & Johnson — Xeplion EMA EPAR public assessment repor, p.94 |
| Time to recurrence (p-value) | <0.0001 | Johnson & Johnson — Xeplion EMA EPAR public assessment repor, p.88 |
| PANSS total score change from baseline (LS mean difference) | -14.0 | Johnson & Johnson — Xeplion EMA EPAR public assessment repor, p.68 |
| CGI-S score change from baseline (p-value) | <0.0001 | Johnson & Johnson — Xeplion EMA EPAR public assessment repor, p.89 |
| Treatment-emergent adverse events rate | 75 | Johnson & Johnson — Xeplion EMA EPAR public assessment repor, p.99 |
| Number of subjects exposed to paliperidone palmitate | 3605 | Johnson & Johnson — Xeplion EMA EPAR public assessment repor, p.99 |
| CHMP positive opinion for Marketing Authorisation | 16 December 2010 | Johnson & Johnson — Xeplion EMA EPAR public assessment repor, p.4 |
| Onset of efficacy for paliperidone palmitate | 8 | Johnson & Johnson — Xeplion EMA EPAR public assessment repor, p.97 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.