New Data on Latuda for Schizophrenia Announced

New Data on Latuda for Schizophrenia Announced
New Data on Latuda for Schizophrenia Announced

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).

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  • 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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