Takeda and Sunovion announced new data on the short and long-term efficacy, safety, and tolerability of lurasidone (Latuda; Sunovion) in adults with schizophrenia. The evidence was presented during multiple poster sessions at the 27th European College of Neuropsychopharmacology (ECNP).
Results presented in the poster sessions include:
- In a multi-regional, double-blind study of adult patients with schizophrenia and without metabolic syndrome at baseline, after 12 months of treatment the risk of developing metabolic syndrome was reduced by 48% in patients treated with flexibly dosed once-daily Latuda (37-111mg/day) relative to patients treated with flexibly dosed risperidone (2–6mg/day) (HR 0.52; 95% CI, 0.24–1.15). Metabolic syndrome prevalence decreased in patients who completed 12 months of risperidone treatment and switched to Latuda in a six-month open label extension study; after 12 months of double-blind risperidone treatment, the prevalence of metabolic syndrome was 48.4% and was reduced to 38.5% after six months of open-label Latuda treatment.
- Latuda was found to be a well-tolerated and efficacious option for adult patients switching to Latuda after 12 months of double-blind treatment with risperidone in a six-month open-label extension (OLE) study. Switching to Latuda was associated with a mean change in weight of -2.9kg; patients who continued using Latuda experienced a -0.6kg mean weight loss after an additional six months of treatment at the study endpoint. In addition, a decrease in prolactin levels was also observed in patients who switched from risperidone to Latuda (median change from open-label extension study baseline to endpoint: men, -11.2ng/mL; women, -30.8ng/mL).
- A post-hoc analysis of a six-week, double-blind study found that daytime sleepiness improved in adult patients with schizophrenia taking Latuda and placebo, but worsened in the quetiapine XR (Seroquel XR; AstraZeneca) group compared to placebo (P=0.001) and to either dose of Latuda (P<0.01).
- A post-hoc analysis of patients with prominent negative symptoms showed that Latuda was associated with significantly greater Week 6 improvement in Positive and Negative Syndrome Scale (PANSS) score vs. placebo on the PANSS-negative subscale score (-6.3 vs. -4.5; P<0.01).
- In a 12-month blinded, controlled study of adult patients with schizophrenia, Latuda 37–148mg/day was demonstrated to be non-inferior to Seroquel XR 600–800mg/day in prevention of relapse. The probability of relapse was 23.7% for patients receiving Latuda and 33.6% for Seroquel XR. Remission rates based on full Remission in Schizophrenia Working Group (RSWG) criteria requiring improvement for at least six months were 61.9% for Latuda and 46.8% for Seroquel XR (P=0.056).
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