The drug lurasidone (trade name Latuda) has been available since November 2014 for the treatment of adults with schizophrenia. The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in a dossier assessment whether this new drug offers an added benefit over the appropriate comparator therapy.
According to the findings, an added benefit is not proven: it is uncertain both in the acute treatment and in the prevention of relapse whether the effect lurasidone has on the symptoms of schizophrenia is as good as that of the appropriate comparator therapies.
Lurasidone in the acute treatment was investigated in three comparative studies (RCTs) and compared with risperidone, olanzapine or quetiapine XR. However, the dosages of lurasidone and of the appropriate comparator therapies in the studies deviated from the guideline and the respective Summary of Product Characteristics. It is uncertain whether this led to a potential over- or underestimation of effects. Hence there are doubts about the suitability of the studies for the benefit assessment.
The drug manufacturer based its conclusions on the added benefit of lurasidone for acute treatment solely on a reduction of side effects. These would only be relevant however if it was proven that lurasidone was as effective with regard to schizophrenia symptoms as the appropriate comparator therapies. This cannot be inferred from the manufacturer dossier.
For more details, go to: https://www.iqwig.de/en/press/press-releases/press-releases/lurasidone-in-schizophrenia-added-benefit-is-not-proven.6543.html