Human medicines European public assessment report (EPAR): Latuda, lurasidone, Date of authorisation: 21/03/2014, Revision: 26, Status: Authorised

Latuda has been investigated in six main studies. Three short-term studies compared Latuda with placebo (a dummy treatment) over 6 weeks in a total of 1,466 adults. The main measure of effectiveness was the change in symptoms, measured using a standard scale for schizophrenia called ‘positive and negative syndrome scale’ (PANSS). In these studies, Latuda was found to be more effective than placebo, lowering the PANSS score by up to 16 points more than placebo; however, this effect was not consistent for each dose studied and it was not possible to see a consistent pattern of greater improvement with higher doses. Further analyses of the results by the company supported the likelihood of short-term benefits of treatment with Latuda.

One of the short-term studies was continued to 12 months to look at the effect of continuing use of Latuda in 292 adults, compared with the medicine quetiapine; two other studies, involving 914 adults, looked at the long-term effects of Latuda compared with another schizophrenia medicine, risperidone, or with placebo. In these long-term studies, effectiveness was measured in terms of the percentage of patients whose condition worsened, and whose symptoms came back during treatment. In the extension study, Latuda was at least as effective as quetiapine, with the condition worsening in 21% of patients treated with Latuda within 1 year, compared with 27% of patients treated with quetiapine. Latuda was not found to be as effective as risperidone in the second study but the available data supported a long-term benefit. The last study showed that the condition worsened in 30% of patients treated with Latuda within one year, compared with 41% of patients receiving placebo.

A further study involved 326 patients aged 13 to 17 years with schizophrenia whose symptoms had worsened markedly in the previous 2 months. After 6 weeks, PANSS scores improved by over 18 points in patients taking Latuda compared with an improvement of 10.5 points in those receiving placebo. Continuing use of Latuda for up to 2 years led to further improvement in PANSS scores.