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NEW ORLEANS — Paliperidone palmitate 1-month and 3-month (PP1M and PP3M) treatments have been linked to meaningful symptom improvement or remission in schizophrenia, according to research presented at the US Psych Congress, held September 16-19 in New Orleans, Louisiana.
Researchers from Janssen Pharmaceuticals conducted a post-hoc analysis of a phase 3 trial (ClinicalTrials.gov identifier: NCT01515423) examining the efficacy of PP1M vs PP3M in treating adults with schizophrenia.
Study participants (n=411) included adults with a DSM-IV diagnosis of schizophrenia, a Positive and Negative Syndrome Scale (PANSS) score between 70 and 120, and worsening schizophrenia symptoms.
During the study’s open-label phase, participants received PP1M for 17 weeks (150 mg eq on day 1; 100 mg eq on day 8; flexible doses [50, 75, 100, or 150 mg at weeks 5 and 9 and a repeat of the week 9 dose at week 13). Patients considered clinically stable at weeks 14 and 17 were entered into the double-blind study phase and randomly assigned to receive 1:1 fixed doses of either PP1M (50, 75, 100, or 150 mg) or PP3M (175, 263, 350, or 525 mg).
At the conclusion of the double-blind period, 63.3% of patients receiving PP3M achieved remission, with “significantly greater” improvements in PANSS, Clinical Global Impression (CGI), and PSP measures.
“Clinicians can obtain optimal clinical outcomes with PP3M by ensuring that their patients’ schizophrenia symptoms are well-managed for at least 12 weeks on PP1M prior to transition [to PP3M],” the researchers concluded.
Nash AI, Turkoz I, Savitz A, Matthews M, Kim E. Predictors of achieving remission in schizophrenia patients treated with paliperidone palmitate. Presented at: US Psych Congress; September 16-19, 2017; New Orleans, Lousiana.